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Background: Medical internet interventions such as asynchronous apps and synchronous digital live seminars can be effective behavior change interventions. The research question of this study was whether digital interventions based on the Health Action Process Approach can improve pregnant women's safe communication and patient safety in obstetric care. Objective: This study aims to compare a digital live seminar with a web-based application intervention and a passive control group and to identify which social cognitive variables determine safe communication behavior and patient safety. Methods: In total, 657 pregnant women were recruited, and hereof, 367 expectant mothers from 2 German university hospitals participated in the pre-post study (live seminar: n=142; web-based app: n=81; passive control group: n=144). All interventions targeted intention, planning, self-efficacy, and communication of personal preferences. The 2.5-hour midwife-assisted live seminar included exercises on empathy and clear communication. The fully automated web-based application consisted of 9 consecutive training lessons with the same content as that of the live seminar. Results: Controlled for sociodemographic characteristics, repeated measures analyses of covariance revealed that pregnant women significantly improved their self-reported communication behavior in all groups. The improvement was more pronounced after the digital live seminar than after the web-based application (P<.001; ηp²=0.043). Perceived patient safety improved more for pregnant women participating in the live seminar than for those participating in the web-based application group (P=.03 ηp²=0.015). A regression analysis revealed that social cognitive variables predicted safe communication behavior. Conclusions: Overall, the web-based application intervention appeared to be less effective than the digital live training in terms of communication behavior. Application interventions addressing communication behaviors might require more face-to-face elements. Improving intention, coping planning, and coping self-efficacy appeared to be key drivers in developing safe communication behavior in pregnant women. Future research should include social learning aspects and focus on the practical application of medical internet interventions when aiming to improve pregnant women's communication and patient safety in obstetrics. [ABSTRACT FROM AUTHOR]

Background: Loneliness, or perceived social isolation, is prevalent in both the general population and clinical practice. Although loneliness has repeatedly been associated with mental and physical health, research on interventions that reduce loneliness effectively is still rather scarce. Objective: This study aims to evaluate the efficacy of a guided and an unguided version of the same internet-based cognitive behavioral self-help program for loneliness (SOLUS-D) for adults. Methods: A total of 250 participants will be randomly assigned to 1 of 2 intervention groups (SOLUS-D with guidance or SOLUS-D without guidance) or a wait-list control group (2:2:1 allocation ratio). Adult participants experiencing high levels of loneliness will be recruited from the general population. Individuals currently experiencing at least moderately severe depressive symptoms, an ongoing severe substance use disorder, previous or current bipolar or psychotic disorder, or acute suicidality will be excluded from the trial. Assessments will take place at baseline, 5 weeks (midassessment), and 10 weeks (postassessment). The primary outcome is loneliness assessed using the 9-item University of California, Los Angeles Loneliness Scale at the posttreatment time point. Secondary outcomes include depressive symptoms, symptoms of social anxiety, satisfaction with life, social network size, and variables assessing cognitive bias and social behavior. The maintenance of potentially achieved gains will be assessed and compared at 6 and 12 months after randomization in the 2 active conditions. Potential moderators and mediators will be tested exploratorily. Data will be analyzed on an intention-to-treat basis. Results: Recruitment and data collection started in May 2021 and are expected to be completed by 2022, with the 12-month follow-up to be completed by 2023. As of the time of submission of the manuscript, 134 participants were randomized. Conclusions: This 3-arm randomized controlled trial will add to the existing research on the efficacy of loneliness interventions. Furthermore, it will shed light on the role of human guidance in internet-based treatments for individuals with increased levels of loneliness and the possible mechanisms of change. If SOLUS-D proves effective, it could provide a low-threshold, cost-efficient method of helping and supporting individuals with increased levels of loneliness. [ABSTRACT FROM AUTHOR]

Background and Aims: Alcohol consumption is increasing among older adults. Rethink My Drink is a brief internet-delivered intervention to reduce alcohol consumption and related harms, adapted specifically for older adults. This protocol for a large-scale randomised controlled trial will evaluate whether Rethink My Drink is effective in reducing alcohol consumption and cognitive decline in a sample of older risky drinkers, compared with an active control. Design: 1:1 parallel group, randomised controlled trial. Setting: Online trial in Australia. Participants: Hazardous or harmful drinkers (defined as those scoring =5 on the Alcohol Use Disorders Identification Test [AUDIT]) age 60 to 75 years old (n = 842). Participants will be recruited from August 2021 to August 2022 through online social media advertisements and community networks. Intervention and Comparator: Participants will be randomly allocated to receive access to Rethink My Drink (intervention) or Alcohol: The Facts (comparator), an online patient information booklet provided by New South Wales (NSW) Health. Measurements: Primary outcomes include (i) average weekly standard drinks and (ii) rate of cognitive decline. Secondary outcomes include (i) typical quantity of drinks per drinking day; (ii) heavy episodic drinking; (iii) age-specific risky drinking; (iv) alcoholrelated harms; (v) subjective cognitive complaints; and (vi) quality of life. All primary and secondary outcomes will be assessed at baseline, post-intervention (4 weeks) and 12 months. Effectiveness will be evaluated using multilevel linear regression, adjusting for baseline demographic differences. Bonferroni adjustments will be used to control for multiple comparisons. Multiple imputation, regression weighting and sensitivity analyses will assess the effect of attrition. Comments: This will be the first large-scale trial, internationally, to examine whether a brief internet-delivered intervention is effective in reducing alcohol consumption and cognitive decline among older adults. If successful, the intervention will provide an accessible and highly scalable treatment to reduce risky alcohol consumption in older adulthood. [ABSTRACT FROM AUTHOR]

Importance: In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment.Objective: To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder.Design, Setting and Participants: A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020.Interventions: Participants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment.Main Outcomes and Measures: The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS.Results: Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group).Conclusions and Relevance: Among children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings.Trial Registration: ClinicalTrials.gov Identifier: NCT03263546. [ABSTRACT FROM AUTHOR]

Background: Mental disorders are highly prevalent among university students. Distance-learning students are particularly burdened and have limited access to conventional university health services. Interventions for stress are sought after in distance learners and may help increase treatment coverage. Internet-based interventions have been shown to be effective in preventing and treating depression, but it remains unclear if interventions directed at academic stress also have this potential. Aim: The trial presented here investigates the effectiveness of an Internet- and App-based stress intervention in distance-learning students with elevated levels of depression. Methods: A sample of N = 200 students of a large German distance university with elevated levels of depression [Center for Epidemiological Studies' Depression Scale (CES-D) ≥ 16] will be randomly assigned to either an Internet- and App-based stress management intervention group (IG) or a control group (CG) receiving an Internet-based psychoeducational program for academic stress. The IG consists of eight Internet-based sessions promoting stress management skills using cognitive–behavioral and problem-solving techniques. A mobile App will be employed to facilitate training transfer. Self-report data will be assessed at baseline (T0), post-treatment (T1; 7 weeks), and 3-month follow-up (T2). Potential moderators will be assessed at baseline. The primary outcome is depression (CES-D) post-treatment. Secondary outcomes include mental health outcomes, modifiable risk and protective factors, and academic outcomes. Data will be analyzed on an intention-to-treat principle along with sensitivity analyses to assess the robustness of findings. Additional health economic analyses will be conducted. Discussion: Results will provide the basis to assess the acceptance and effectiveness of Internet-delivered stress interventions in distance-learning students with symptoms of depression. Ethics and dissemination: The study has been reviewed and approved by the University of Erlangen-Nuremberg ethics committee (Erlangen, Germany; 33_17 Bc). Results of the study will be disseminated through peer-reviewed publications. Trial Registration: German Clinical Trial Registration (DRKS), identifier DRKS00011800 [ABSTRACT FROM AUTHOR]

Background: The development of efficacious, cost-effective, and widely accessible programs for the prevention of eating disorders (EDs) is crucial in order to reduce the ED-related burden of illness. Programs using dissonance-based and cognitive behavioral approaches are most effective for the selective prevention of ED. Internet-based delivery is assumed to maximize the reach and impact of preventive efforts. However, the current evidence for Internet-based ED prevention is limited. The present trial evaluates the efficacy and cost-effectiveness of two new interventions (based on dissonance theory and principles of cognitive behavioral therapy (CBT)) that are implemented as add-ons to the existing Internet-based ED prevention program ProYouth.Methods: The trial is one of five sub-projects of the German multicenter consortium ProHEAD. It is a three-arm, parallel, randomized controlled superiority trial. Participants will be randomized to (1) the online program ProYouth (active control condition) or (2) ProYouth plus a structured dissonance-based module or (3) ProYouth plus a CBT-based chat group intervention. As part of ProHEAD, a representative school-based sample of N = 15,000 students (≥ 12 years) will be screened for mental health problems. N = 309 participants at risk for ED (assessed with the Weight Concerns Scale (WCS) and the Short Evaluation of Eating Disorders (SEED)) will be included in the present trial. Online assessments will be conducted at baseline, at end of intervention (6 weeks), at 6 months follow-up, and - as part of ProHEAD - at 12 and 24 months follow-up. The primary outcome is ED-related impairment (assessed with the Child version of the Eating Disorder Examination-Questionnaire (ChEDE-Q)) at the end of the intervention. Secondary outcomes include ED-related symptomatology at follow-up, ED-related stigma, ED-related help-seeking, and acceptance of and compliance with the interventions. For the health economic evaluation data on costs of the interventions, healthcare utilization and health-related quality of life will be assessed.Discussion: This is the first study augmenting a flexible prevention approach such as ProYouth with structured evidence-based modules in order to overcome some of the key limitations in the current practice of ED prevention.Trial Registration: German Clinical Trials Register (DRKS), DRKS00014679 . Registered on 25 April 2018. [ABSTRACT FROM AUTHOR]

Background: Clinical guidelines recommend psychosocial care as an integral part of medical treatment, but access is often limited. Technology-based approaches provide an attractive opportunity to optimize health outcomes and quality of life in people with chronic somatic diseases e.g. by means of Internet- and mobile-based interventions (IMIs). The present article provides an overview on the basics of IMIs, applications and their evidence base for people living with chronic somatic diseases. Methods: We conducted a selective literature search in the PubMed and Cochrane databases. Reviews which included randomized controlled trials investigating psychological IMIs were discussed pertaining to their relevance for the population described. Results: IMIs lead to a change in unfavorable behavior connected to chronic somatic diseases. IMIs can foster protective factors like balanced physical activity or risk factors like smoking or alcohol consumption. However, studies reveal small effect sizes of d=0.25 for physical activity and an averaged effect size of d=0.20 for smoking and alcohol consumption. Additionally, IMIs can be used for the (co-)treatment of chronic somatic diseases, for instance to increase disease-specific selfefficacy in patients with diabetes (d=0.23). Studies included in meta-analyses are often highly heterogenous and are investigated in research contexts with limited health care services relevance. Conclusion: IMIs are potentially effective when aiming at lifestyle changes and supporting medical treatment in people with chronic somatic diseases. However, results are still heterogenous and the evidence base is limited regarding specific settings, compounding the discussion of possible ways of implementing IMIs into our healthcare systems. [ABSTRACT FROM AUTHOR]

Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed. [ABSTRACT FROM AUTHOR]

Background: Behavioral and psychological symptoms of dementia (BPSD) are universal and associated with multiple negative outcomes. This pilot randomized controlled trial (RCT) evaluated the effect of using the WeCareAdvisor, an innovative web-based tool developed to enable family caregivers to assess, manage, and track BPSD.Methods: This RCT enrolled 57 dementia family caregivers from community and clinical settings in Ann Arbor, Michigan and Baltimore, Maryland. Participants were randomly assigned to immediate use of the WeCareAdvisor tool (WCA, n = 27) or a Waitlist control group (n = 30) that received the tool after a one-month waiting period. Outcomes for the caregiver and the person they were caring for were assessed at baseline (T0) and one-month followup for both the WCA (T1) and Waitlist control (T2) groups.Results: Caregiver mean age was 65.9 ± 14.0 years old. About half (49%) were spouses. Baseline characteristics were comparable between groups except for mean caregiver confidence which was higher in the control group (WCA 35.0 ± 10.0 vs. Waitlist control 39.7 ± 6.9, p = 0.04). There were no significant differences between the WCA and control groups in characteristics of the person with dementia. After their one-month of tool use (T1), WCA caregivers showed significant within group improvement in caregiver distress (- 6.08 ± 6.31 points, t = - 4.82, p < 0.0001) and behavioral frequency (- 3.60 ± 5.05, t = - 3.56, p = 0.002), severity (- 3.24 ± 3.87, t = - 4.19, p = 0.0003) and total behavioral score (- 6.80 ± 10.73, t = - 3.17, p = 004). In the same timeframe, Waitlist control caregivers showed a significant decrease in confidence (- 6.40 ± 10.30, t = - 3.40, p = 0.002). The WCA group showed greater improvement in distress compared to the Waitlist group (T0-T1; t = - 2.49, p = 0.02), which remained significant after adjusting for site and baseline distress. There were no significant between-group differences in caregiver confidence or other secondary outcomes. After their one month of tool use (T2), the Waitlist group also showed significant improvement in caregiver distress (- 3.72 ± 7.53, t = - 2.66, p = 0.013), stress (- 0.41 ± 1.02, t = - 2.19, p = 0.037), confidence (4.38 ± 5.17, t = 4.56, p < 0.0001), burden (- 2.76 ± 7.26, t = - 2.05, p = 0.05), negative communication (- 1.48 ± 2.96, t = - 2.70, p = 0.012) and behavioral frequency (- 1.86 ± 4.58, t = - 2.19, p = 0.037); distress remained significant after adjustment.Conclusions: In this pilot RCT, WCA use resulted in a significant decrease in caregiver distress. Future research will identify whether longer use of WCA can impact other caregiver and behavioral outcomes.Trial Registration: Clinicaltrials.gov identifier NCT02420535 (Date of registry: 4/20/2015, prior to the start of the clinical trial). [ABSTRACT FROM AUTHOR]

eHealth is an innovative method of delivering therapeutic content with the potential to improve access to third-wave behaviural and cognitive therapies. This systematic review and meta-analysis aimed to determine the efficacy and acceptability of third-wave eHealth treatments in improving mental health outcomes. A comprehensive search of electronic bibliographic databases including PubMed, PsycINFO, Web of Science, and CENTRAL was conducted to identify randomized controlled trials of third-wave treatments in which eHealth was the main component. Twenty-one studies were included in the review. Meta-analyses revealed that third-wave eHealth significantly outperformed inactive control conditions in improving anxiety, depression, and quality-of-life outcomes and active control conditions in alleviating anxiety and depression with small to medium effect sizes. No statistically significant differences were found relative to comparison interventions. Findings from a narrative synthesis of participant evaluation outcomes and meta-analysis of participant attrition rates provided preliminary support for the acceptability of third-wave eHealth. Third-wave eHealth treatments are efficacious in improving mental health outcomes including anxiety, depression, and quality of life, but not more so than comparison interventions. Preliminary evidence from indices of participant evaluation and attrition rates supports the acceptability of these treatments. [ABSTRACT FROM AUTHOR]

Background: Previous research suggests that providing information to women newly diagnosed with breast cancer, during the gap between cancer diagnosis and their first surgeon consultation, may support decision making. Our objective was to compare patients' knowledge after the pre-consultation delivery of standard websites vs a web-based decision aid (DA).Study Design: We randomized women with stage 0 to III breast cancer, within an academic and community breast clinic, to be emailed a link to selected standard websites (National Cancer Institute, American Cancer Society, Breastcancer.org,) vs the Health Dialog DA (Clinicaltrials.govNCT03116035). Patients seeking second opinions, diagnosed by excisional biopsy, or without an email address, were ineligible. Pre-consultation knowledge was assessed using the Breast Cancer Surgery Decision Quality Instrument. We compared differences in knowledge using t-test.Results: Median patient age was 59 years, 99% were white, and 65% had a college degree or higher, with no differences in demographics between study arms. Knowledge was higher in patients who received the DA (median 80% vs 66% correct, p = 0.01). Decision-aid patients were more likely to know that waiting a few weeks to make a treatment decision would not affect survival (72% vs 54%, p < 0.01). Patients in both arms found the information helpful (median score 8 of 10).Conclusions: Although patients found receipt of any pre-consultation information helpful, the DA resulted in improved knowledge over standard websites and effectively conveyed that there is time to make a breast cancer surgery decision. Decreasing the urgency patients feel may improve the quality of patient-surgeon interactions and lead to more informed decision-making. [ABSTRACT FROM AUTHOR]

Background: Even though there is an increasing number of studies on the efficacy of Internet-based interventions (IBI) for depression, experimental trials on the benefits of added guidance by clinicians are scarce and inconsistent. This study compared the efficacy of semistandardized feedback provided by psychologists with fully standardized feedback in IBI.Methods: Participants with mild-to-moderate depression (n = 1,089, 66% female) from the client pool of a health insurance company participated in a cognitive-behavioral IBI targeting depression over 6 weeks. Individuals were randomized to weekly semistandardized e-mail feedback from psychologists (individual counseling; IC) or to automated, standardized feedback where a psychologist could be contacted on demand (CoD). The contents and tasks were identical across conditions. The primary outcome was depression; secondary outcomes included anxiety, rumination, and well-being. Outcomes were assessed before and after the intervention and 3, 6, and 12 months later. Changes in outcomes were evaluated using latent change score modeling.Results: Both interventions yielded large pre-post effects on depression (Beck Depression Inventory-II: dIC = 1.53, dCoD = 1.37; Patient Health Questionnaire-9: dIC = 1.20, dCoD = 1.04), as well as significant improvements of all other outcome measures. The effects remained significant after 3, 6, and 12 months. The groups differed with regard to attrition (IC: 17.3%, CoD: 25.8%, p = 0.001). Between-group effects were statistically nonsignificant across outcomes and measurement occasions.Conclusion: Adding semistandardized guidance in IBI for depression did not prove to be more effective than fully standardized feedback on primary and secondary outcomes, but it had positive effects on attrition. [ABSTRACT FROM AUTHOR]

Objective: This randomized controlled trial aimed at evaluating the efficacy of an internet-based cognitive behavioral stress management program (IB-CBSM) for pregnant women with preterm labor (PTL) on birth outcome and stress-related psychological and biological parameters.Methods: 93 pregnant women with PTL (gestational age 18-32) were assigned to either the IB-CBSM (n=50) or a control group (CG) based on distraction (n=43). Participants in both groups worked through six weekly modules. Birth outcome measures included gestational age, neonatal weight and length at birth and the rate of preterm birth (PTB). Questionnaires assessed psychological wellbeing and the activity of the HPA-axis was measured with the cortisol awakening reaction (CAR), both before (T1) and after the intervention (T2).Results: Birth outcome and psychological wellbeing did not differ between IB-CBSM and CG. However, psychological wellbeing was higher after both interventions (PSS: ηp2=0.455, STAIX1: ηp2=0.455, STAIX2: ηp2=0.936, PRAT: ηp2=0.465, EPDS: ηp2=0.856). Cortisol levels were stable and did not alter differently between groups from T1 to T2. Higher cortisol levels were associated with lower gestational age at birth, whereas no significant correlations were found between weight and length at birth.Conclusions: Although there were no significant differences between the two groups and birth outcome, psychological and biological parameters, both interventions (CBSM and CG) showed equivalent effects and proved to be beneficial with regard to psychosocial distress and well-being. Further research is needed to investigate CBSM and distraction interventions for pregnant women at risk for PTB together with a non-intervention control condition. [ABSTRACT FROM AUTHOR]

Major depression occurs in 5-10% of pregnancies and is associated with many negative effects for mother and child, yet treatment options are scarce. To our knowledge, this is the first published randomised controlled trial on Internet delivered Cognitive Behavior Therapy (ICBT) for this group.Objective: To test the efficacy of a pregnancy adapted version of an existing 10-week ICBT-program for depression as well as assessing acceptability and adherence DESIGN: Randomised controlled trial.Setting: Online and telephone.Population or Sample: Self-referred pregnant women (gestational week 10-28 at intake) currently suffering from major depressive disorder.Methods: 42 pregnant women (gestational week 12-28) with major depression were randomised to either treatment as usual (TAU) provided at their antenatal clinic or to ICBT as an add-on to usual care.Main Outcome Measures: The primary outcome was depressive symptoms measured with the Montgomery-Åsberg depression rating scale-self report (MADRS-S). The Edinburgh Postnatal Depression Scale and measures of anxiety and sleep were used. Credibility, satisfaction, adherence and utilization were also assessed.Results: The ICBT group had significantly lower levels of depressive symptoms post treatment (p < 0.001, Hedges g =1.21) and were more likely to be responders (i.e. achieve a statistically reliable improvement) (RR = 0.36; p = 0.004). Measures of treatment credibility, satisfaction, utilization, and adherence were comparable to implemented ICBT for depression.Limitations: Small sample size and no long-term evaluation.Conclusion: Pregnancy adapted ICBT for antenatal depression is feasible, acceptable and efficacious. These results need to be replicated in larger trials to validate these promising findings. [ABSTRACT FROM AUTHOR]

Background: Severe fatigue is a common and distressing symptom affecting approximately one in four survivors of breast cancer. The current study examined the efficacy of Internet-based cognitive behavioral therapy (ICBT) for severe fatigue in survivors of breast cancer compared with care as usual (CAU).Methods: The authors conducted a parallel-group randomized controlled trial. Severely fatigued, disease-free survivors of breast cancer who had completed cancer treatment at least 3 months previously were eligible. Participants were randomly allocated to ICBT or CAU using computer-generated stratified block randomization. The primary outcome of fatigue severity was assessed at baseline and after 6 months, as were the secondary outcomes of functional impairment, psychological distress, and quality of life. Statistical effects were tested with analyses of covariance (intention-to-treat analysis).Results: Participants were recruited between January 2014 and March 2016 and assigned to ICBT (66 patients) or CAU (66 patients). Compared with the participants who had received CAU, those who had received ICBT reported lower fatigue scores at 6 months (mean difference [Δ], 11.5; 95% confidence interval [95% CI], 7.7-15.3) and a large effect size (Cohen d = 1.0), with the majority of patients (73%) demonstrating clinically significant improvement. ICBT also was found to lead to lower functional impairment (Δ, 297.8; 95% CI, 145.5-450.1) and psychological distress scores (Δ, 5.7; 95% CI, 3.4-7.9) and higher quality-of-life scores (Δ, 11.7; 95% CI, 5.8-17.7) compared with CAU, with medium to large effect sizes (Cohen d = 0.6-0.8).Conclusions: ICBT appears to be effective in reducing severe fatigue and related symptoms and meets the current need for easy accessible and more efficient evidence-based treatment options for severely fatigued survivors of breast cancer. Cancer 2017;123:3825-34. © 2017 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: Depression in multiple sclerosis (MS) patients is common but may stay untreated. Physical limitations impede face-to-face treatment. Internet-based treatment is therefore a promising tool for treating depression in MS. Objectives: To investigate effectiveness of a guided Internet-based problem-solving treatment (IPST) for depressed MS patients. Methods: MS patients with moderate or severe depressive symptoms were randomly assigned to IPST or a wait list control. Primary outcome was the change in depressive symptoms defined by a change in sum score on the Beck Depression Inventory Second Edition (BDI-II). Assessments took place at baseline (T0), within a week after the intervention (T1), and at 4 months follow-up (T2). Analyses were based on the intention-to-treat principle. Results: A total of 171 patients were randomized to IPST (n = 85) or a wait list control (n = 86). T1 was completed by 152 (89%) and T2 by 131 patients (77%). The IPST group and wait list control showed large significant improvements in depressive symptoms, but no differences were found between groups at T1 (d = 0.23; 95% confidence interval (CI) = (−4.03, 1.08); p = 0.259) and T2 (d = 0.01; 95% CI = (−2.80, 2.98); p = 0.953). Conclusion: We found no indication that IPST for MS patients with moderate or severe depression is effective in reducing depressive symptoms compared to a waiting list. Large improvements in the wait list control were unexpected and are discussed. [ABSTRACT FROM AUTHOR]

Background: Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC).Methods/design: The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects.Discussion: This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions.Trial Registration: ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015). [ABSTRACT FROM AUTHOR]

Introduction Self-help computer-based programs are easily accessible and cost-effective interventions with a great recruitment potential. However, each program is different and results of meta-analyses may not apply to each new program; therefore, evaluations of new programs are warranted. The aim of this study was to assess the marginal efficacy of a computer-based, individually tailored program (the Coach) over and above the use of a comprehensive Internet smoking cessation website. Methods A two-group randomized controlled trial was conducted. The control group only accessed the website, whereas the intervention group received the Coach in addition. Follow-up was conducted by e-mail after three and six months (self-administrated questionnaires). Of 1120 participants, 579 (51.7%) responded after three months and 436 (38.9%) after six months. The primary outcome was self-reported smoking abstinence over four weeks. Results Counting dropouts as smokers, there were no statistically significant differences between intervention and control groups in smoking cessation rates after three months (20.2% vs. 17.5%, p = 0.25, odds ratio (OR) = 1.20) and six months (17% vs. 15.5%, p = 0.52, OR = 1.12). Excluding dropouts from the analysis, there were statistically significant differences after three months (42% vs. 31.6%, p = 0.01, OR = 1.57), but not after six months (46.1% vs. 37.8%, p = 0.081, OR = 1.41). The program also significantly increased motivation to quit after three months and self-efficacy after three and six months. Discussion An individually tailored program delivered via the Internet and by e-mail in addition to a smoking cessation website did not significantly increase smoking cessation rates, but it increased motivation to quit and self-efficacy. [ABSTRACT FROM AUTHOR]

Background: The aim of the study was to evaluate the feasibility and effects of an internet-based information and self-help program with therapist contact for parents of children and adolescents with burns. The program aimed to reduce parents' symptoms of general and posttraumatic stress.Methods: Participants were parents of children treated for burns between 2009-2013 at either of the two specialized Swedish Burn centers. Sixty-two parents were included in a two-armed, randomized controlled trial with a six-week intervention group and a wait-list control group, including a pre and post-assessment, as well as a 3 and 12-month follow-up. The intervention contained psychoeducation, exercises and homework assignments, and the intervention group received weekly written feedback from a therapist. The main outcome was stress (post-traumatic stress, general stress and parental stress).Results: The program had a beneficial effect on posttraumatic stress in the short term, but did not affect general stress or parental stress. The parents rated the program as being informative and meaningful, but some of them thought it was time-consuming.Conclusion: The program has the potential to support parents of children with burns. The intervention is easily accessible, cost-effective and could be implemented in burn care rehabilitation. [ABSTRACT FROM AUTHOR]

This study investigated moderators of intervention response in a fully automated Internet-based monitoring and feedback intervention (‘Featback’) with different levels of therapist support for individuals with eating disorder (ED) symptoms. This study was part of a randomized controlled trial comparing four conditions: 1) Featback, 2) Featback with low-intensity (weekly) therapist support, 3) Featback with high-intensity (three times a week) therapist support, and 4) a waiting list. A total of 273 participants completed baseline and post-intervention assessments. The outcome measure was ED psychopathology. Model-based recursive partitioning was applied. Baseline levels of ED psychopathology were found to moderate intervention response. Specifically, in terms of improvement in symptoms of anorexia nervosa, participants with higher baseline levels of anorectic psychopathology showed better outcomes in the waiting list condition and the Featback conditions with low- and high-intensity therapist support in comparison with Featback without therapist support. In terms of improvement in symptoms of bulimia nervosa, participants with mild to moderate bulimic symptoms had better outcomes in the Featback conditions compared with the waiting list. Thus, the fully automated Internet-based intervention with and without therapist support may be particularly suitable in improving mild to moderate bulimic psychopathology, whereas the intervention without therapist support may be less effective in improving severe anorectic psychopathology. Further investigating differential intervention responses is important, as this could help to optimize the delivery and dissemination of E-health interventions and therapist support, which in turn could help moving toward personalized (E-)care. [ABSTRACT FROM AUTHOR]

Background: Suicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicidal thoughts among people at risk of suicide. The Danish Self-help Online against Suicidal thoughts (SOS) trial is a partial replication of a previously conducted Dutch trial.Methods and Design: A randomized, waiting-list controlled trial with 1:1 allocation ratio will be carried out. A total of 438 people with suicidal thoughts will be recruited from the Danish suicide hotline, The Lifeline's, website and allocated to the intervention condition (N = 219) or the control condition (N = 219). The intervention condition consists of a 6-week, Internet-based self-help therapy intervention. The format of the intervention is self-help, but the participants can be guided by the trial manager. The control condition consists of a waiting-list assignment for 32 weeks. The primary outcomes are frequency and intensity of suicidal thoughts. Secondary outcome measures include depressive symptoms, hopelessness, worrying, quality of life, costs related to health care utilization and production loss. Number of deliberate self-harm episodes, suicides and deaths will, as well as the participant's evaluation of the intervention and the experience of negative effects, be investigated. Assessments will be conducted over the intervention website through self-report questionnaires at baseline, 2 weeks, 4 weeks, 6 weeks and 32 weeks (6 months post intervention).Discussion: If we find the intervention to be linked to reductions in suicidal thoughts, this will strengthen the evidence that online self-help interventions are relevant tools for people with suicidal thoughts.Trial Registration: ClinicalTrials.gov, NCT02872610 . Registered on 9 August 2016. [ABSTRACT FROM AUTHOR]

Background: Internet-based self-help psychotherapy (IBT) could be an important alternative or supplement to ordinary face-to-face therapy. The findings of randomised controlled trials indicate that the effects of various IBT programmes for anxiety disorders seem better than no intervention and in some instances are equivalent to usual therapy. In Denmark, IBT is part of future treatment plans in mental health care services, but the verification level of the current clinical scientific knowledge is insufficient. The objective of this trial is feasibility assessment of benefits and harms of the Internet-based cognitive behavioural therapy (ICBT) programme FearFighter™ versus no intervention for anxiety disorders in adults. Methods and design: We will conduct an investigator-initiated, feasibility randomised controlled trial. Sixty-four participants are expected to be recruited via an advertisement posted on the homepage of the Student Counselling Service in Denmark. The inclusion criterion for participation in the trial will be the presence of anxiety disorder as assessed with the Mini International Neuropsychiatric Interview. The exclusion criteria will be suicidal risk, an ongoing episode of bipolar disorder or psychosis, concurrent psychological treatment for the anxiety disorder, considered unable to attend the intervention as planned (due to vacation, work/study placement, sickness, or similar occurrences), or lack of informed consent. The intervention group will be offered nine sessions with the ICBT programme FearFighter™ and a weekly telephone contact to support compliance. The control group will receive no intervention. We define the feasibility outcomes as follows: the fraction of randomised participants out of the eligible people (the lower 95% confidence interval (CI) ≥ 50%); and the fraction of compliant participants (those receiving at least six out of nine sessions) in the intervention group (the lower 95% CI ≥ 60%). The exploratory clinical outcomes are the number of participants no longer meeting the diagnostic criteria for an anxiety disorder at the end of the trial and level of distress (Beck Anxiety Inventory, Symptom Checklist-90-R, WHO Well-Being Index, Sheehan Disability Scale); the number of severe adverse events; and the occurrence of any psychological treatment outside the trial. To prevent bias in design, and in the gathering and analysis of data throughout the trial, we will follow the SPIRIT 2013 statement which defines standard protocol items for clinical trials. Discussion: Based on our findings, we will discuss the feasibility of a future randomised controlled trial examining the benefits and harms of FearFighter™ versus no intervention for anxiety disorders in adults. [ABSTRACT FROM AUTHOR]

Background: Mental illness is a substantial and rising contributor to the global burden of disease. Access to and utilization of mental health care, however, is limited by structural barriers such as specialist availability, time, out-ofpocket costs, and attitudinal barriers including stigma. Innovative solutions like virtual care are rapidly entering the health care domain. The advancement and adoption of virtual care for mental health, however, often occurs in the absence of rigorous evaluation and adequate planning for sustainability and spread. Methods: A pragmatic randomized controlled trial with a nested comparative effectiveness arm, and concurrent realist process evaluation to examine acceptability, effectiveness, and cost-effectiveness of the Big White Wall (BWW) online platform for mental health self-management and peer support among individuals aged 16 and older who are accessing mental health services in Ontario, Canada. Participants will be randomized to 3 months of BWW or treatment as usual. At the end of the 3 months, participants in the intervention group will have the opportunity to opt-in to an intervention extension arm. Those who opt-in will be randomized to receive an additional 3 months of BWW or no additional intervention. The primary outcome is recovery at 3 months as measured by the Recovery Assessment Scale-revised (RAS-r). Secondary outcomes include symptoms of depression and anxiety measured with the Personal Health Questionnaire-9 item (PHQ-9) and the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7) respectively, quality of life measured with the EQ-5D-5L, and community integration assessed with the Community Integration Questionnaire. Cost-effectiveness evaluations will account for the cost of the intervention and direct health care costs. Qualitative interviews with participants and stakeholders will be conducted throughout. Discussion: Understanding the impact of virtual strategies, such as BWW, on patient outcomes and experience, and health system costs is essential for informing whether and how health system decision-makers can support these strategies system-wide. This requires clear evidence of effectiveness and an understanding of how the intervention works, for whom, and under what circumstances. This study will produce such effectiveness data for BWW, while simultaneously exploring the characteristics and experiences of users for whom this and similar online interventions could be helpful. [ABSTRACT FROM AUTHOR]

There is significant interest in the potential of Internet-delivered pain management programs for adults with chronic pain. Understanding the characteristics of people who do and do not benefit from Internet-delivered programs will help to guide their safe and effective use. Using a large sample from a previous randomised controlled trial of an established Internet-delivered pain management program, the Pain Course, this study (n = 463) examined whether several demographic, clinical, psychological, and treatment-related variables could be used to predict clinical response in levels of disability, depression, anxiety, or average pain. Multiple univariate and multivariate stepwise logistic regressions were used to identify unique predictors of clinical improvement, which, consistent with recommendations, was defined as a ≥30% reduction in symptoms or difficulties from baseline. Several unique predictors of clinical improvement were found. However, no particularly decisive or dominant predictors emerged that were common across time points or across the outcome domains. Reflecting this, the identified predictors explained only 18.1%, 13.7%, 7.6%, and 9.5% of the variance in the likelihood of making a clinical improvement in disability, depression, anxiety, and average pain levels, respectively. The current findings suggest that a broad range of patients may benefit from emerging Internet-delivered pain management programs and that it may not be possible to predict who will or will not benefit on the basis of patients' demographic, clinical, and psychological characteristics. [ABSTRACT FROM AUTHOR]

Objective: This experiment tested the effects of an individualized risk-based online mammography decision intervention. The intervention employs exemplification theory and the Elaboration Likelihood Model of persuasion to improve the match between breast cancer risk and mammography intentions.Methods: 2918 women ages 35-49 were stratified into two levels of 10-year breast cancer risk (<1.5%; ≥1.5%) then randomly assigned to one of eight conditions: two comparison conditions and six risk-based intervention conditions that varied according to a 2 (amount of content: brief vs. extended) x 3 (format: expository vs. untailored exemplar [example case] vs. tailored exemplar) design. Outcomes included mammography intentions and accuracy of perceived breast cancer risk.Results: Risk-based intervention conditions improved the match between objective risk estimates and perceived risk, especially for high-numeracy women with a 10-year breast cancer risk ≤1.5%. For women with a risk≤1.5%, exemplars improved accuracy of perceived risk and all risk-based interventions increased intentions to wait until age 50 to screen.Conclusion: A risk-based mammography intervention improved accuracy of perceived risk and the match between objective risk estimates and mammography intentions.Practice Implications: Interventions could be applied in online or clinical settings to help women understand risk and make mammography decisions. [ABSTRACT FROM AUTHOR]

Background: Regular physical activity (PA) is recommended for persons with chronic obstructive pulmonary disease (COPD). Interventions that promote PA and sustain long-term adherence to PA are needed.Objective: We examined the effects of an Internet-mediated, pedometer-based walking intervention, called Taking Healthy Steps, at 12 months.Methods: Veterans with COPD (N=239) were randomized in a 2:1 ratio to the intervention or wait-list control. During the first 4 months, participants in the intervention group were instructed to wear the pedometer every day, upload daily step counts at least once a week, and were provided access to a website with four key components: individualized goal setting, iterative feedback, educational and motivational content, and an online community forum. The subsequent 8-month maintenance phase was the same except that participants no longer received new educational content. Participants randomized to the wait-list control group were instructed to wear the pedometer, but they did not receive step-count goals or instructions to increase PA. The primary outcome was health-related quality of life (HRQL) assessed by the St George's Respiratory Questionnaire Total Score (SGRQ-TS); the secondary outcome was daily step count. Linear mixed-effect models assessed the effect of intervention over time. One participant was excluded from the analysis because he was an outlier. Within the intervention group, we assessed pedometer adherence and website engagement by examining percent of days with valid step-count data, number of log-ins to the website each month, use of the online community forum, and responses to a structured survey.Results: Participants were 93.7% male (223/238) with a mean age of 67 (SD 9) years. At 12 months, there were no significant between-group differences in SGRQ-TS or daily step count. Between-group difference in daily step count was maximal and statistically significant at month 4 (P<.001), but approached zero in months 8-12. Within the intervention group, mean 76.7% (SD 29.5) of 366 days had valid step-count data, which decreased over the months of study (P<.001). Mean number of log-ins to the website each month also significantly decreased over the months of study (P<.001). The online community forum was used at least once during the study by 83.8% (129/154) of participants. Responses to questions assessing participants' goal commitment and intervention engagement were not significantly different at 12 months compared to 4 months.Conclusions: An Internet-mediated, pedometer-based PA intervention, although efficacious at 4 months, does not maintain improvements in HRQL and daily step counts at 12 months. Waning pedometer adherence and website engagement by the intervention group were observed. Future efforts should focus on improving features of PA interventions to promote long-term behavior change and sustain engagement in PA.Clinicaltrial: Clinicaltrials.gov NCT01102777; https://clinicaltrials.gov/ct2/show/NCT01102777 (Archived by WebCite at http://www.webcitation.org/6iyNP9KUC). [ABSTRACT FROM AUTHOR]

Background: Brief interventions in primary healthcare are cost-effective in reducing drinking problems but poorly implemented in routine practice. Although evidence about implementing brief interventions is growing, knowledge is limited with regard to impact of initial role security and therapeutic commitment on brief intervention implementation.Methods: In a cluster randomised factorial trial, 120 primary healthcare units (PHCUs) were randomised to eight groups: care as usual, training and support, financial reimbursement, and the opportunity to refer patients to an internet-based brief intervention (e-BI); paired combinations of these three strategies, and all three strategies combined. To explore the impact of initial role security and therapeutic commitment on implementing brief interventions, we performed multilevel linear regression analyses adapted to the factorial design.Results: Data from 746 providers from 120 PHCUs were included in the analyses. Baseline role security and therapeutic commitment were found not to influence implementation of brief interventions. Furthermore, there were no significant interactions between these characteristics and allocated implementation groups.Conclusions: The extent to which providers changed their brief intervention delivery following experience of different implementation strategies was not determined by their initial attitudes towards alcohol problems. In future research, more attention is needed to unravel the causal relation between practitioners' attitudes, their actual behaviour and care improvement strategies to enhance implementation science.Trial Registration: ClinicalTrials.gov: NCT01501552. [ABSTRACT FROM AUTHOR]

Objectives: Several studies have shown that perseverative, worrisome thoughts are prospectively related to subjective health complaints (SHC) and that a short worry postponement intervention can decrease these complaints. As SHC and worry are prevalent and costly, we tested whether the intervention can be offered online to reduce these complaints in the general population.Design: A randomized parallel-group trial was conducted with self-selected participants from the general population.Methods: Via the research website, 996 participants were instructed to register their worrying for 6 consecutive days. The intervention group was instructed to postpone worry to a special 30-min period in the early evening. The Subjective Health Complaints inventory, as administered before and after the intervention, and daily worry frequency and duration were considered the primary outcomes.Results: Three hundred and sixty-one participants completed the study. Contrary to our expectation, the registration group (n = 188) did not differ from the intervention group (n = 163) in SHC (ηp² = .000, CI [0.000-0.003]), or in worry frequency or duration. Nevertheless, the different worry parameters were moderately related to SHC (r between .238 and .340, p ≤ .001).Conclusions: In contrast to previous studies using pen-and-pencil versions of the worry postponement intervention, this study suggests that a direct online implementation was not effective in reducing SHC and worry. Overall, participants had high trait worry levels and reported difficulty with postponing worrying. Reducing SHC and worries via the Internet might require more elaborate interventions that better incorporate the advantages of delivering interventions online.Statement Of Contribution: What is already known on this subject? The perseverative cognition hypothesis argues that perseverative cognition, such as worry and rumination, acts as a mediator by which psychosocial stress may produce negative health effects. Prior research has indeed shown that worry and subjective health complaints (SHC) are prospectively related, but causality studies - that is, showing that changes in worry induce changes in health outcomes - are scarce and have mainly been conducted in young samples. These studies showed that reducing worry, using a worry postponement intervention, can reduce daily worrying and SHC. What does this study add? Trait and daily worrying are associated with SHC. An online worry postponement intervention is ineffective in reducing worry and SHC. Paper-and-pencil interventions cannot directly be used as online interventions. [ABSTRACT FROM AUTHOR]

Aim: The aim of this article was to develop and apply an Internet-based headache diary (i-diary) for adolescents and compare it with a paper-diary (p-diary) regarding adherence, user acceptability and recorded headache activity.Methods: In a cross-sectional school-based study, a representative sample of 488 adolescents aged 12-18 years were randomly allocated by cluster sampling to record for three weeks in i-diaries or p-diaries their headache intensity, disability, and use of acute medication.Results: A significantly (p = 0.008) higher proportion of adolescents in the i-diary group used the diary at least once during the 21-day period (86% vs 76% for the p-diary). However, the p-diary group completed a significantly (p < 0.001) higher number of diary days (20.8 vs 15.0 days for the i-diary). The response rate for the i-diary-group was largely evenly distributed over the study period; conversely, approximately two-thirds of the adolescents using the p-diary responded on all 21 days, whereas one-fourth did not respond at all. The two diary types were rated as equal in easiness to remember (p = 0.25), but the i-diaries were more bothersome to use (p = 0.029).Conclusion: Although p-diary users completed a higher proportion of diary days, i-diaries provided more reliable and credible estimates of headache parameters because of better real-time assessment. [ABSTRACT FROM AUTHOR]

Background: Long-term weight loss maintenance is difficult to achieve. Effectiveness of obesity interventions could be increased by providing extended treatment, and by focusing on person-environment interactions. Ecological Momentary Intervention (EMI) can account for these two factors by allowing an indefinite extension of a treatment protocol in everyday life. EMI relies on observations in daily life to intervene by providing appropriate in-the-moment treatment. The Think Slim intervention is an EMI based on the principles of cognitive behavioural therapy (CBT), and its effectiveness will be investigated in the current study. Methods: A randomised controlled trial (RCT) will be conducted. At least 134 overweight adults (body mass index (BMI) above 25 kg/m(2)) will be randomly assigned to an 8-week immediate intervention group (Diet + Think Slim intervention, n = 67) or to an 8-week diet-only control group (followed by the Think Slim intervention, n = 67). The Think Slim intervention consists of (1) an app-based EMI that estimates and intervenes when people are likely to overeat, based on Ecological Momentary Assessment data, and (2) ten online computerised CBT sessions which work in conjunction with an EMI module in the app. The primary outcome is BMI. Secondary outcomes include (1) scores on self-report questionnaires for dysfunctional thinking, eating styles, eating disorder pathology, general psychological symptomatology, and self-esteem, and (2) eating patterns, investigated via network analysis. Primary and secondary outcomes will be obtained at pre- and post-intervention measurements, and at 3- and 12-month follow-up measurements. Discussion: This is the first EMI aimed at treating obesity via a cognitive approach, provided via a smartphone app and the Internet, in the context of an RCT. Trial Registration: This trial has been registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre ( NTR5473 ; registration date: 26 October 2015). [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the efficacy of a self-guided Web-based cognitive behaviour therapy (CBT) intervention compared to an attention control in improving cancer-related distress, health-related quality of life (HRQOL), and maladaptive coping, among people recently diagnosed with cancer.Methods: Sixty individuals with cancer diagnosed in the previous 6 months and receiving treatment with curative intent were randomised to receive either the 6-week intervention Cancer Coping Online (CCO: n = 30) or the 6-week Web-based attention control (n = 30). Outcome measures, including cancer distress (the Posttraumatic Stress Scale - Self-Report), general distress (Depression Anxiety Stress Scale), quality of life (EORTC QLQ-C30), and coping (mini-MAC), were administered at baseline, immediately post-intervention, and at 3 and 6 months post-intervention.Results: Significant main effects for time were found for cancer distress, global QOL, physical function, role function, social function, and anxious preoccupation. Post hoc between-group comparisons showed CCO participants had statistically significantly higher physical functioning compared to controls at 3 months of follow-up (d = -0.52, p = 0.02). Furthermore, compared to controls, post hoc comparisons found moderate between-group effect sizes favouring CCO post-intervention for cancer distress (d = 0.43) and anxious preoccupation (d = 0.38), and at 6 months of follow-up for global QOL (d = -0.43).Conclusions: These results provide preliminary support for the potential efficacy of a self-guided Web-based CBT programme in improving aspects of HRQOL, cancer-related distress, and anxious preoccupation after cancer diagnosis. This paper provides justification for, and will help inform the development of, subsequent larger multi-site studies. [ABSTRACT FROM AUTHOR]

This study aimed to establish the efficacy of guided Internet-delivered cognitive-behaviour therapy (ICBT) for older adults with generalized anxiety disorder (GAD) or subclinical GAD. Participants were randomized to receive seven modules of ICBT ( n = 24) or to a waiting list condition (WLC; n = 22). Faster improvements in symptoms of anxiety and depression were observed for participants in the ICBT condition relative to the WLC, with large between-group effect sizes on the Generalized anxiety disorder-7 ( d = .85) and the Patient health questionnaire ( d = 1.17) obtained at post-treatment. Further reduction in generalized anxiety symptoms was reported over the one-month follow-up. Treatment effects were replicated when control participants subsequently underwent treatment. Higher ratings of treatment credibility, but not expectancy, prior to ICBT predicted improvements over time. The results support the efficacy of ICBT as treatment for older adults with GAD. [ABSTRACT FROM AUTHOR]

Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = -1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = -2.66, P = 0.007) and protective behaviors (b = -0.19, P = 0.001), and on treatment satisfaction (P values < 0.05). On exploratory outcomes, benefits of Internet CBT were found for parent-perceived impact (ie, reductions in depression, anxiety, self-blame about their adolescent's pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families. [ABSTRACT FROM AUTHOR]

Generalized anxiety disorder (GAD) can be treated effectively with either disorder-specific cognitive behavior therapy (DS-CBT) or transdiagnostic CBT (TD-CBT). The relative benefits of DS-CBT and TD-CBT for GAD and the relative benefits of delivering treatment in clinician guided (CG-CBT) and self-guided (SG-CBT) formats have not been examined. Participants with GAD ( n = 338) were randomly allocated to receive an internet-delivered TD-CBT or DS-CBT intervention delivered in either CG-CBT or SG-CBT formats. Large reductions in symptoms of GAD (Cohen’s d ≥ 1.48; avg. reduction ≥ 50%) and comorbid major depressive disorder (Cohen’s d ≥ 1.64; avg. reduction ≥ 45%), social anxiety disorder (Cohen’s d ≥ 0.80; avg. reduction ≥ 29%) and panic disorder (Cohen’s d ≥ 0.55; avg. reduction ≥ 33%) were found across the conditions. No substantive differences were observed between DS-CBT and TD-CBT or CG-CBT and SG-CBT, highlighting the public health potential of carefully developed TD-CBT and SG-CBT. [ABSTRACT FROM AUTHOR]

Background Internet-delivered treatments for depression have proved successful, with supported programs offering the potential for improved adherence and outcomes. Internet interventions are particularly interesting in the context of increasing access to interventions, and delivering interventions population-wide. Methods The study was a randomized controlled trial of an 7-module internet-delivered cognitive behavioral therapy (iCBT) program for adults with depressive symptoms ( n = 96) compared to a waiting-list control group ( n = 92). Participants received weekly support from a trained supporter. The primary outcome was depressive symptoms as measured by the Beck Depression Inventory (BDI-II). The program was made available nationwide from an established and recognized charity for depression. Results For the treatment group, post-treatment effect sizes reported were large for the primary outcome measure ( d = 0.91). The between-group effects were moderate to large and statistically significant for the primary outcomes ( d = 0.50) favoring the treatment group. Gains were maintained at 6-month follow-up. Conclusion The study has demonstrated the efficacy of the internet-delivered Space from Depression treatment. Participants demonstrated reliable and statistically significant changes in symptoms from pre-to post-intervention. The study supports a model for delivering online depression interventions population-wide using trained supporters. Trial registration number : Current Controlled Trials ISRCTN03704676. http://dx.doi.org/10.1186/ISRCTN03704676. [ABSTRACT FROM AUTHOR]

The article discusses a study which examined whether adding mobile cognitive therapy (M-CT) to treatment as usual (TAU) is clinically superior to TAU alone over 24 months in depressed individuals. Topics covered include the cumulative relapse/recurrence rate after 24 months, the effectiveness of guided and unguided internet-based treatments, and long-term effects of face-to-face preventive cognitive therapy (PCT) and other face-to-face relapse prevention strategies.

Background: Effective web-assisted tobacco interventions (WATIs) have been underutilized by smokers; moreover, despite practice guideline recommendations, clinical teams do not routinely refer smokers to WATIs. Our goal was to test a clinical practice innovation, an ePortal designed to change practice and patient behavior. Our hypotheses were that the integrated system would result in increased smoker referrals, with an automated follow-up system resulting in more smoker registrations and finally augmentations of the WATI would result in more smokers quitting at 6 months.Methods: Practice ePortal Implementation Trial: Practices (n = 174) were randomized to an online practice ePortal with an "e-referral tool" to the WATI (e-referred smokers received automated email reminders from the practice) and with practice feedback reports with patient tracking and practice-to-patient secure messaging versus comparison (a paper "referral prescription"). Implementation success was measured by the number of smokers referred and smokers registering. Clinical Effectiveness Trial: To estimate the effectiveness of the WATI components on 6-month smoking cessation, registered smokers were randomized into three groups: a state-of-the-art tailored WATI control [control], the WATI enhanced with proactive, pushed tailored email motivational messaging (messaging), and the WATI with messaging further enhanced with personal secure messaging with a tobacco treatment specialist and an online support group (personalized).Results: Practice ePortal Trial results: A total of 4789 smokers were referred. The mean smokers referred per practice was not statistically different by group (ePortal 24.89 (SD 22.29) versus comparison 30.15 (SD 25.45), p = 0.15). The e-referral portal implementation program resulted in nearly triple the rate of smoker registration (31 % of all smokers referred registered online) versus comparison (11 %, p < 0.001). Clinical Effectiveness Trial results: Active smokers randomized to the personalized group had a 6-month cessation rate of 25.2 %, compared with the messaging group (26.7 %) and the control (17 %). Next, when using an inverse probability weighted selection model to account for attrition, those randomized to the two groups that received motivational messaging (messaging or personalized) were more likely to quit than those in the control (p = 0.04).Conclusions: Among all smokers referred, the e-referral resulted in nearly threefold greater registrants (31 %) than paper (11 %). The practice ePortal smokers received multiple reminders (increasing registration opportunities), and the practices could track patient progress. The result was more smokers registering and, thus, more cessation opportunities. Combining the proactive referral and the WATI resulted in higher rates of smoking cessation.Trial Registration: Web-delivered Provider Intervention for Tobacco Control (QUIT-PRIMO) - a randomized controlled trial: NCT00797628 . [ABSTRACT FROM AUTHOR]

Background and Objectives: This study evaluated the effectiveness of a web-based stress management program among community college students that focused on increasing perceived control over stressful events. Design: Students (N = 257) were randomly assigned to a Present Control Intervention or a Stress-information only comparison group. Methods: Primary outcomes were perceived stress and stress symptoms; secondary outcomes were depression and anxiety. Self-report measures were completed online at preintervention, postintervention, and three-week follow-up. Intervention effects were estimated using linear mixed models. Seventy-five percent of the sample (n = 194) completed the pretest and comprised the intent-to-treat sample. Results: Participants in the intervention group reported significant increases in present control, and significant decreases in all four primary and secondary outcome measures from baseline to postintervention and follow-up. Within-group effect sizes were small to medium at postintervention (mean d = -.34) and follow-up (mean d = -.49). The mean between-group effect size on the four outcome measures was d = .35 at postintervention but d = .12 at follow-up, due to unexpected decreases in distress in the comparison group. Conclusions: Our online program is a cost-effective mental health program for college students. Limitations and future direction are discussed. [ABSTRACT FROM AUTHOR]

Internet-based interventions can be effective treatments for anxiety and depression. Meta-analytic evidence suggests that they should be delivered with human support to reach optimal effects. These findings have not consistently been replicated in direct comparisons of supported and unsupported interventions, however. This study examined the role of support in Internet-based problem solving treatment (PST) for symptoms of anxiety and/or depression. Adults with mild to moderate symptoms of anxiety and/or depression were recruited from the general population and randomized to: (1) PST without support (n = 107), (2) PST with support on request (n = 108), (3) PST with weekly support (n = 106), (4) no Internet-based intervention but non-specific chat or email (n = 110), or (5) waitlist control (WLC; n = 106). Primary outcomes were symptoms of anxiety (HADS) and depression (CES-D) measured at baseline and 6 weeks later. Analyses were first based on the intention-to-treat principle (ITT) and repeated with intervention completers. Only participants who received PST with weekly support improved significantly more than WLC for depressive symptoms. Results for anxiety were less robust but in favor of the weekly support condition. The results underscore the importance of structural support in Internet-based interventions for depression and anxiety. [ABSTRACT FROM AUTHOR]

Web-based interventions for people with depressive symptoms are needed and show promising effects. However, it is a consistent finding that human support is needed and this makes implementation costly. This study investigates the adherence and effectiveness of a human-supported and automated-supported web-based intervention for people with mild to moderate depressive symptomatology, and studies the impact of four persuasive technology components. People with mild to moderate depressive symptoms according to the Center of Epidemiological Studies depression scale self-report questionnaire were included, but no diagnosis was made for the study. Participants ( n = 239) were randomized into one of eight intervention arms, where each level of each component is present in half of the intervention arms. On clinical outcomes, there was a significant interaction effect between support condition and time, but there was no difference on the extent of improvement from baseline to follow-up, only a difference in the time-path of improvement. Effect sizes from baseline to follow-up were 0.89 for automated and 1.00 for human support. There was no significant difference on adherence between support condition. We conclude that an automated-supported web-based intervention for treatment of depression with persuasive technology may achieve similar adherence and effectiveness as the same intervention with human support. [ABSTRACT FROM AUTHOR]

Internet-based interventions show promise as an effective channel for promoting physical activity. However, a paucity of research has been conducted among underserved groups despite recent increases in Internet access and physical activity-related health disparities in these communities. Thus, the current randomized controlled trial will test the efficacy of an individually tailored, Internet-based physical activity intervention for Latinas. This program was culturally and linguistically adapted for the target population through extensive formative research. Two hundred eighteen sedentary Latinas were randomly assigned to the Tailored Physical Activity Internet Intervention or the Wellness Contact Control Internet Group. The Physical Activity Internet Intervention, based on Social Cognitive Theory and the Transtheoretical Model, utilizes a website with features including self-monitoring, goal setting, discussion forum, links to online resources, individually tailored and motivation-matched physical activity feedback reports, and exercise tip sheets. Participants receive regular emails over the first 6 months with a tapered dose during the second 6 months (maintenance phase) to alert them to new content on the website. The main outcome is differences in minutes/week of moderate to vigorous physical activity at six months as measured by the 7-Day Physical Activity Recall and accelerometer data. High reach, low cost, culturally relevant Internet-based interventions that encourage physical activity among Latinas could help reduce health disparities and thus have a substantial positive impact on public health. [ABSTRACT FROM AUTHOR]

Background Prostate cancer (PCa) poses many emotional and physical challenges for men following treatment. The unmet support needs of these men are well documented, and access to psychosocial support remains problematic. Objectives To assess the efficacy of an online psychological intervention for men who have localised PCa. Design, setting, and participants We undertook a randomised controlled trial to evaluate the intervention. Participants were randomly allocated to one of three conditions: My Road Ahead (MRA) alone (MRA Only), MRA plus access to an online forum (MRA + Forum), and access to the forum alone (Forum). Intervention The intervention was a 10-week self-guided online psychological intervention called My Road Ahead that consisted of six themed modules designed to facilitate improved emotional well-being in the context of PCa as well as a moderated peer forum. Outcome measurements and statistical analysis Pre- and postintervention assessments of psychological distress (the 21-question Depression, Anxiety and Stress Scale) [1] and the Prostate Cancer–related Quality of Life scale [2] were conducted. Multivariate analysis of variance, regression, and structural equation modelling were used to analyse the data. Results and limitations In total, 142 participants were randomly allocated to one of the three intervention arms. The mean age of participants was 61 yr of age (standard deviation: 7), and 88% had undergone radical prostatectomy. A significant improvement in psychological distress was observed for participants who had access to the combined condition (MRA + Forum) with a moderate effect size ( p = 0.02; partial η 2 = 0.07). In particular, the decline in the mean level of psychological distress was 8.8 units larger for the MRA + Forum group than the Forum group (95% confidence interval [CI], 0.9–16.7). Although the decline in the mean level of psychological distress was 7.0 units larger for the MRA + Forum group than for the MRA Only group, this difference was not significant (95% CI, 1.1–15.1). Structural equation modelling indicated that reductions in health worry and regret contributed significantly to the reductions in psychological distress for the MRA + Forum condition. Conclusions This study is the first, to our knowledge, that has evaluated a self-guided online psychological intervention tailored to the specific needs of men who have PCa. The findings of this study indicate the potential for this programme to deliver support that men may not otherwise receive. Patient summary This study found that men who have localised prostate cancer who received access to the online psychological intervention called My Road Ahead combined with the online peer discussion forum had significantly improved reductions in distress compared with those who received access to the online intervention alone or the forum alone. [ABSTRACT FROM AUTHOR]

Aim To evaluate if internet-delivered Cognitive Behavioral Therapy for insomnia (ICBT-i) with brief therapist support outperforms an active control treatment. Method Adults diagnosed with insomnia were recruited via media (n = 148) and randomized to either eight weeks of ICBT-i or an active internet-based control treatment. Primary outcome was the insomnia severity index (ISI) assessed before and after treatment, with follow-ups after 6 and 12 months. Secondary outcomes were use of sleep medication, sleep parameters (sleep diary), perceived stress, and a screening of negative treatment effects. Hierarchical Linear Mixed Models were used for intent-to-treat analyses and handling of missing data. Results ICBT-i was significantly more effective than the control treatment in reducing ISI (Cohen's d = 0.85), sleep medication, sleep efficiency, sleep latency, and sleep quality at post-treatment. The positive effects were sustained. However, after 12 months the difference was no longer significant due to a continuous decrease in ISI among controls, possibly due to their significantly higher utilization of insomnia relevant care after treatment. Forty-six negative effects were reported but did not differ between interventions. Conclusions Supported ICBT-i is more effective than an active control treatment in reducing insomnia severity and treatment gains remain stable one year after treatment. [ABSTRACT FROM AUTHOR]

Background: A cancer diagnosis elicits greater distress than any other medical diagnosis, and yet very few studies have evaluated the efficacy of structured online self-help therapeutic programs to alleviate this distress. This study aims to assess the efficacy over time of an internet Cognitive Behaviour Therapy (iCBT) intervention ('Finding My Way') in improving distress, coping and quality of life for individuals with a recent diagnosis of early stage cancer of any type. Methods/Design: The study is a multi-site Randomised Controlled Trial (RCT) seeking to enrol 188 participants who will be randomised to either the Finding My Way Intervention or an attention-control condition. Both conditions are delivered online; with 6 modules released once per week, and an additional booster module released one month after program-completion. Participants complete online questionnaires on 4 occasions: at baseline (immediately prior to accessing the modules); post-treatment (immediately after program-completion); then three and six months later. Primary outcomes are general distress and cancer-specific distress, with secondary outcomes including Health-Related Quality of Life (HRQoL), coping, health service utilisation, intervention adherence, and user satisfaction. A range of baseline measures will be assessed as potential moderators of outcomes. Eligible participants are individuals recently diagnosed with any type of cancer, being treated with curative intent, aged over 18 years with sufficient English language literacy, internet access and an active email account and phone number. Participants are blinded to treatment group allocation. Randomisation is computer generated and stratified by gender. Discussion: Compared to the few prior published studies, Finding My Way will be the first adequately powered trial to offer an iCBT intervention to curatively treated patients of heterogeneous cancer types in the immediate post-diagnosis/ treatment period. If found efficacious, Finding My Way will assist with overcoming common barriers to face-to-face therapy in a cost-effective and accessible way, thus helping to reduce distress after cancer diagnosis and consequently decrease the cancer burden for individuals and the health system. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12613000001796 16.10.13 [ABSTRACT FROM AUTHOR]

Background: Sexual dysfunction is a prevalent, long-term complication of breast cancer and its treatment and can be treated effectively with face-to-face sexual counselling. However, relatively few women actually opt for face-to-face sex therapy, with many women indicating that it is too confronting. Internet-based interventions might be a less threatening and more acceptable approach, because of the convenience, accessibility and privacy it provides. Recent studies have demonstrated the efficacy of internet-based programs for improving sexual functioning in the general population. The objective of the current study is to investigate the efficacy of an internet-based cognitive behavioral therapy (CBT) program in alleviating problems with sexuality and intimacy in women who have been treated for breast cancer. Methods/design: In a multicenter, randomized controlled trial we are evaluating the efficacy of an internet-based CBT program in reducing problems with sexuality and intimacy in breast cancer survivors. Secondary outcomes include body image, marital functioning, psychological distress, menopausal symptoms, and health-related quality of life. We will recruit 160 breast cancer survivors (aged 18-65 years) with a formal DSM-IV diagnosis of sexual dysfunction from general and academic hospitals in the Netherlands. Women are randomized to either an intervention or waiting-list control group. Self-report questionnaires are completed by the intervention group at baseline (T0), ten weeks after start of therapy (T1), post-treatment (T2), 3 months post-treatment (T3), and 9 months post-treatment (T4). The control group completes questionnaires at T0, T1 and T2. Discussion: There is a need for accessible and effective interventions for the treatment of sexual dysfunctions in breast cancer survivors. This study will provide evidence about the efficacy of an internet-based approach to delivering a CBT intervention targeted specifically at these sexual health issues. If proven to be effective, internet-based CBT for problems with sexuality and intimacy will be a welcome addition to the care offered to breast cancer survivors. Hopefully this therapy will lower the barrier to seeking help for these problems, resulting in improved quality of life after breast cancer. Trial registration: The study is registered at ClinicalTrials.gov (NCT02091765). [ABSTRACT FROM AUTHOR]

Background and Aims: Internet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania). Methods: Participants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures. Results: A significant difference with a large between-group effect size in favor of iCBT was found (Cohen´s d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen´s d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants’ functioning, as the treatment gains were maintained six months later. Conclusions: Internet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania. Trial Registration: ClinicalTrials.gov [ABSTRACT FROM AUTHOR]

Background Internet-based interventions (IBI) are effective in treating depression. However, uptake rates in routine care are still limited. Hence, this study aimed to (1) assess the acceptance of IBIs in primary care patients with depressive symptoms and to (2) examine the effects of a brief acceptance facilitating intervention in the form of an informational video on patients׳ acceptance of IBIs. Methods Primary care patients ( N =128) with Minor or Major Depression were randomly assigned to an intervention (IG) or control group (CG). Patients in the IG were shown a brief informational video about IBIs before receiving a questionnaire that assessed their acceptance of IBIs and other secondary outcomes. Patients of the CG filled out the questionnaire immediately. Results Baseline acceptance of IBIs in the CG was high for 6.3%, moderate for 53.1% and low for 40.6% of patients. Acceptance of IBIs was significantly higher in the IG when compared to the CG ( d =.71, 95%–CI:.09–2.91). Except for social influence and the general attitude towards psychological treatment , all secondary outcomes were also significantly improved (e.g. effort- ( d= .40) and performance-expectancy: d =.65; knowledge about Internet interventions d= .35). Limitations Depression of the participants was only assessed using a self-report measure (PHQ-9). Conclusion Primary care patients׳ acceptance of IBIs for depressive symptoms was low but could be increased significantly using a brief acceptance facilitating intervention on the basis of an informational video. Future studies should further examine the potential of acceptance facilitating interventions for patients and health care providers to exploit the public health impact of IBIs. [ABSTRACT FROM AUTHOR]

Background: The aim of this paper was to study primary care staff members' experiences and perceptions of participating in a randomized controlled trial concerning Internet therapy. Methods: Data were collected via five focus groups, each containing four to eight nurses or general practitioners. The systematic text condensation method described by Malterud was used for thematic analysis of meaning and content of data across cases. Results: The informants believed it was important to conduct research within the primary care setting, but it was difficult to combine clinical work and research. They stressed also that there was a need for continuous information and communication between primary care centers and researchers as well as internally at each primary care center. Conclusion: Staff members' experiences of participating in a research study were positive, although associated with various difficulties. It is important to include staff members when designing clinical studies; information should be given continuously during the study and communication facilitated between different occupational groups working at the primary care center. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depression in children and adolescents are undertreated. Computer- and Internet-based cognitive behavioral treatments (cCBT) may be an attractive treatment alternative to regular face-to-face treatment.This meta-analysis aims to evaluate whether cCBT is effective for treating symptoms of anxiety and depression in youth. Methods and Findings: We conducted systematic searches in bibliographical databases (Pubmed, Cochrane controlled trial register, PsychInfo) up to December 4, 2013. Only randomized controlled trials in which a computer-, Internet- or mobile-based cognitive behavioral intervention targeting either depression, anxiety or both in children or adolescents up to the age of 25 were compared to a control condition were selected. We employed a random-effects pooling model in overall effect analyses and a mixed effect model for sub-group analyses. Searches resulted in identifying 13 randomized trials, including 796 children and adolescents that met inclusion criteria. Seven studies were directed at treating anxiety, four studies at depression, and two were of a transdiagnostic nature, targeting both anxiety and depression. The overall mean effect size (Hedges’ g) of cCBT on symptoms of anxiety or depression at post-test was g=0.72 (95% CI:0.55-0.90, numbers needed to be treated (NNT)=2.56). Heterogeneity was low (I²=20.14%, 95% CI: 0-58%). The superiority of cCBT over controls was evident for interventions targeting anxiety (g=0.68; 95% CI: 0.45-0.92; p < .001; NNT=2.70) and for interventions targeting depression (g=0.76; 95% CI: 0.41-0.12; p < .001; NNT=2.44) as well as for transdiagnostic interventions (g=0.94; 95% CI: 0.23-2.66; p < .001; NNT=2.60). Conclusions: Results provide evidence for the efficacy of cCBT in the treatment of anxiety and depressive symptoms in youth. Hence, such interventions may be a promising treatment alternative when evidence based face-to-face treatment is not feasible. Future studies should examine long-term effects of treatments and should focus on obtaining patient-level data from existing studies, to perform an individual patient data meta-analysis. [ABSTRACT FROM AUTHOR]