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Background and Hypothesis Based on a childhood intervention from ages 3 to 5 years that included additional fish consumption and which resulted in reduced schizotypal personality at age 23, we had previously hypothesized that omega-3 could reduce schizotypy. The current study tests the hypothesis that omega-3 supplementation reduces schizotypy in children. Study Design In this intention-to-treat, randomized, single-blind, stratified, factorial trial, a community sample of 290 children aged 11–12 years were randomized into Omega-3 Only, Cognitive Behavioral Therapy (CBT) Only, Omega-3 + CBT, and Control groups. Schizotypy was assessed using the SPQ-C (Schizotypal Personality Questionnaire for Children) at 0 months (baseline), 3 months (end of treatment), 6 months (3 months post-treatment), and 12 months (9 months post-treatment). Study Results A significant group × time interaction (P  = .013) indicated that, compared with Controls, total schizotypy scores were reduced in both Omega-3 Only and Omega-3 + CBT groups immediately post-treatment (d  = 0.56 and 0.47, respectively), and also 3 months after supplementation terminated (d  = 0.49, d  = 0.70). Stronger findings were observed for the interpersonal schizotypy factor, with both omega-3 groups showing reductions 9 months post-treatment compared with the CBT Only group. Schizotypy reductions were significantly stronger for those with higher dietary intake of omega-3 at intake. Sensitivity analyses confirmed findings. Conclusions Results are unique in the field and suggest that omega-3 can help reduce schizotypal personality in community-residing children. From an epidemiological standpoint, if replicated and extended, these findings could have implications for early prevention of more significant schizotypal features developing later in adolescence. Clinical Trial Registration "Healthy Brains & Behavior: Understanding and Treating Youth Aggression (HBB)." ClinicalTrials.gov Identifier: NCT00842439 , https://clinicaltrials.gov/ct2/show/NCT00842439. [ABSTRACT FROM AUTHOR]

Background: We compared dissociative seizure specific cognitive behavior therapy (DS-CBT) plus standardized medical care (SMC) to SMC alone in a randomized controlled trial. DS-CBT resulted in better outcomes on several secondary trial outcome measures at the 12-month follow-up point. The purpose of this paper is to evaluate putative treatment mechanisms. Methods: We carried out a secondary mediation analysis of the CODES trial. 368 participants were recruited from the National Health Service in secondary / tertiary care in England, Scotland, and Wales. Sixteen mediation hypotheses corresponding to combinations of important trial outcomes and putative mediators were assessed. Twelve-month trial outcomes considered were final-month seizure frequency, Work and Social Adjustment Scale (WSAS), and the SF-12v2, a quality-of-life measure providing physical (PCS) and mental component summary (MCS) scores. Mediators chosen for analysis at six months (broadly corresponding to completion of DS-CBT) included: (a) beliefs about emotions, (b) a measure of avoidance behavior, (c) anxiety and (d) depression. Results: All putative mediator variables except beliefs about emotions were found to be improved by DS-CBT. We found evidence for DS-CBT effect mediation for the outcome variables dissociative seizures (DS), WSAS and SF-12v2 MCS scores by improvements in target variables avoidance behavior, anxiety, and depression. The only variable to mediate the DS-CBT effect on the SF-12v2 PCS score was avoidance behavior. Conclusions: Our findings largely confirmed the logic model underlying the development of CBT for patients with DS. Interventions could be additionally developed to specifically address beliefs about emotions to assess whether it improves outcomes. [ABSTRACT FROM AUTHOR]

Background: Online psychological interventions have emerged as a treatment alternative because they are accessible, flexible, personalized, and available to large populations. The number of Internet interventions in Latin America is limited, as are Randomized Controlled Trials (RCTs) of their effectiveness and a few studies comparing their effectiveness in multiple countries at the same time. We have developed an online intervention, Well-being Online, which will be available to the public free of charge in 7 countries: Mexico, Ecuador, Peru, Chile, Brazil, Spain, and the Netherlands. We expect a reduction in depression and anxiety symptoms and an increase in well-being of the participants. Methods: A multi-country, randomized controlled trial will be conducted. The intervention is multicomponent (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness, Acceptance and Commitment Therapy, and Positive Psychology), with 10 sessions. In each country, eligible participants will be randomized to one of three groups: Enriched Intervention (interactive web design with videos, infographics, text, audio, and forum), Text Intervention (text on the website), and Wait List (control group). Repeated measures will be obtained at 5-time points. Our primary outcomes will be anxiety symptomatology, depressive symptomatology, and mental well-being. MANOVA analysis will be used for our main analysis. Discussion: This protocol describes the design of a randomized trial to evaluate the efficacy of a web-based intervention to reduce anxiety and depression symptomatology and increase subjective well-being. The intervention will be made available in four languages (Spanish, Portuguese, Dutch, and English). Its results will contribute to the evidence of effectiveness in terms of randomized trials and Internet interventions, mainly in Latin America and Europe. [ABSTRACT FROM AUTHOR]

This paper summarizes the results of the Improving Mood with Psychoanalytic and Cognitive Therapies (IMPACT) study and its implications for psychological treatment of adolescents with moderate to severe unipolar major depression. IMPACT was a pragmatic, superiority, randomized controlled trial conducted in the United Kingdom, which compared the clinical and cost-effectiveness of short-term psychoanalytic therapy (STPP), cognitive−behavioral therapy (CBT), and a brief psychosocial intervention (BPI) in reducing depression symptoms in 465 adolescents with unipolar major depression, aged 11 to 17 years. Although this was a clinically heterogeneous group of adolescents, some symptoms (eg, sleep and concentration difficulties, irritability/anger) were common and disabling. The trial reported no significant difference among the 3 treatments in reducing depression symptoms. One year after treatment, 84% of participants showed improvement in depressive symptoms (<50% of baseline symptoms) and improved psychosocial functioning, achieving this through different symptom reduction trajectories. Although participants attended fewer treatment sessions than planned, the 3 treatments were delivered with fidelity to their respective models. Ending treatment without therapist agreement occurred in 37% of cases. This was not associated with outcomes by treatment group. Adolescents emphasized the importance of the therapeutic relationship in all 3 treatments. Results suggest that although most adolescents respond to time-limited, structured psychological therapy, subgroups of depressed adolescents are likely to need additional treatment or support. These include adolescents who live in complex circumstances and/or who believe that their needs are not met in therapy, some who stop treatment early, and the 16% to 18% of adolescents who do not respond to treatment. Improving Mood and Preventing Relapse With Psychoanalytic Psychotherapy and Cognitive Behaviour Therapy; https://www.isrctn.com ; ISRCTN83033550. [ABSTRACT FROM AUTHOR]

Discrepancies between sleep diaries and actigraphy occur among individuals with insomnia. Cognitive behavioural therapy for insomnia (CBT-I) improves insomnia but the impact on discrepancy is unclear. This study examined CBT-I's effects on actigraphy-diary discrepancy and explored sleep-related beliefs and attitudes as a mediator. Participants were 108 (age M ± SD = 47.23 ± 12.42, 67.60 % female) adults with insomnia and major depressive disorder from the Treatment of Insomnia and Depression study. They were randomized to 7 sessions of CBT-I or sham Quasi-Desensitization Therapy for Insomnia (DTI), plus 16 weeks of antidepressants. Two weeks of actigraphy and sleep diary were collected at baseline, mid-treatment, end-treatment. Differences between sleep diary and actigraphy total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE) were calculated. Participants completed Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) at baseline and mid-treatment. At baseline, diary (versus actigraphy) TST was shorter (1.1 ± 1.41h), whilst SOL (21.64 ± 41.25min) and WASO (17.45 ± 61.99min) were longer. Mixed effects models using daily data showed that after adjusting for age and sex, participants in the CBT-I group (versus DTI) showed greater reduction in all actigraphy-diary discrepancy domains (all p-values <.01), reductions evident from mid-treatment. Group differences on actigraphy-diary discrepancy reductions in TST, SOL, and SE (not WASO) were mediated by changes in DBAS from baseline to mid-treatment (all p-values <.05). Changes in discrepancy did not mediate insomnia symptom changes (p-values >.39). CBT-I reduced actigraphy-diary discrepancy in individuals with comorbid insomnia and depression; this reduction was associated with improved sleep-related attitudes, a therapeutic target of CBT-I. TRIAD (Treatment of Insomnia and Depression): Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants. Prospectively registered with Clinical Trials (NCT00767624). MH078924, MH078961, MH079256. • Individuals with insomnia and depression reported shorter and worse sleep compared to actigraphy measures. • CBT-I reduced actigraphy-diary discrepancy in these individuals. • Discrepancy reduction was associated with improved sleep-related attitudes and beliefs. [ABSTRACT FROM AUTHOR]

Background: The highly recurrent nature of Major Depressive Disorder is a major contributor to disability and health care costs. Several studies indicate that recurrence may be prevented with Preventive Cognitive Therapy (PCT). This study is the first to perform an economic evaluation of PCT in comparison with care as usual for recurrently depressed patients who experienced two or more depressive episodes and remitted after receiving Cognitive Behavioural Therapy. Methods: An economic evaluation from the societal perspective was performed alongside a randomized trial (N = 214). Health-related quality of life (QALYs), depression-free days, health care utilization, and productivity losses were measured between randomization and 15 months follow-up. The costs were indexed to the reference year 2014. Results: QALY gains did not differ significantly between the groups (p = 0.69). Depression-free days were higher after PCT (p = 0.02). Societal costs of PCT were 10,417 euro and for care as usual 9,545 euro per person. We found a 47% likelihood that PCT led to additional QALYs at higher costs, and there was a 26% likelihood that PCT led to fewer QALYs at higher costs. When depression-free days was used as an outcome, we found PCT had a 72% likelihood of leading to more depression-free days at higher costs than care as usual and a 27% likelihood of leading to more depression-free days at lower societal costs. Limitations: The 15-month follow-up might be too short to draw long-term conclusions about the cost-effectiveness of the PCT. The data collected for this study is part of an RCT to examine the effectiveness of adding PCT to care as usual. Therefore, the study was powered primarily to detect an effect in time to relapse/recurrences. Conclusion: The economic evaluation is slightly in favour of the PCT condition when depression-free days is used as an outcome. PCT is not cost-effective given the high costs per additional QALYs from the societal perspective when QALYs are the effect measure. [ABSTRACT FROM AUTHOR]

The aim of this randomized controlled trial was to evaluate an adapted cognitive behavioural therapy (CBT) programme for treating anxiety in adolescents with acquired brain injury (ABI). Participants with ABI (12–19 years, N = 36) recruited from two sites were randomly allocated into either the intervention receiving 11 sessions of CBT (n = 19) or a wait-list control group (n = 17). The primary outcome was participants' anxiety and secondary outcomes were participants' depression, self-perception, and participation in daily activities, and parental stress, measured at (i) pre-intervention, (ii) immediately post-intervention, (iii) 2 months post-intervention and (iv) 6 months post-intervention. Repeated measures ANOVAs revealed significant treatment effects with the intervention group demonstrating greater improvements in self-reported anxiety, as well as self- and parent-reported depression from pre- to immediately post-treatment, compared to wait-list controls. Little evidence of treatment effects was found for the remaining outcomes (parent-reported anxiety, self-perception, daily participation, and parental stress). Significant improvement in self-reported anxiety found immediately post-treatment was maintained at two- and six-month follow-up. Findings provide support for adapted CBT as an effective means of reducing anxious and depressive symptomatology in adolescents with ABI compared to waitlist controls, and offer support for the use of these techniques to manage anxiety in this population. [ABSTRACT FROM AUTHOR]

Aim: To assess the incremental cost-effectiveness ratio (ICER) of group transdiagnostic cognitive-behavioural therapy (tCBT) added to treatment as usual (TAU) for anxiety disorders compared to TAU only from the healthcare system perspective over a 1-year time horizon. Methods: Data from a pragmatic multisite randomized controlled trial where adults (18–65 years) with an anxiety disorder were randomized to tCBT + TAU (n = 117) or TAU (n = 114). Group tCBT is a 12-week (2h weekly sessions) community-based intervention. Health service utilization and related costs were captured from medico-administrative data and included those for the intervention, ambulatory visits, hospitalizations and medications. Effectiveness was based on quality-adjusted life years (QALYs). The study included measures at baseline, 4, 8, and 12 months. Intention-to-treat and complete case analyses were carried out. Missing data were imputed using multiple imputation analyses. Seemingly unrelated regression analyses were used to assess the effect of the intervention on total costs and QALYs while also adjusting for baseline confounders. The probability of cost-effectiveness of the intervention was assessed according to different willingness-to-pay (WTP) thresholds using the net benefit regression method. Results: The ICER of tCBT + TAU as compared to TAU in the intention-to-treat analysis was $6,581/QALY. Complete case analyses showed a similar ICER of $6,642/QALY. The probability at a WTP threshold of $20,000 and $40,000 that tCBT + TAU as compared to TAU is cost-effective is 93.0% and 99.9%. Conclusion: tCBT added to TAU appears to be cost-effective from the healthcare system perspective for treating adult patients with anxiety disorders. Larger trials including young and older adults as well as a range of anxiety disorders are needed to further investigate the cost-effectiveness of tCBT in different patient populations. [ABSTRACT FROM AUTHOR]

Background: Cognitive behavioural therapy (CBT) reduces MS-related fatigue. However, studies on the long-term effects show inconsistent findings. Objective: To evaluate whether a blended booster programme improves the outcome of CBT for MS-related fatigue on fatigue severity at 1-year follow-up. Method: A multicentre randomized clinical trial in which 126 patients with MS were allocated to either a booster programme or no booster programme (control), after following 20-week tailored CBT for MS-related fatigue. Primary outcome was fatigue severity assessed with the Checklist Individual Strength fatigue subscale 1 year after start of treatment (T52). Mixed model analysis was performed by a statistician blinded for treatment-allocation to determine between-group differences in fatigue severity. Results: Fatigue severity at 1-year follow-up did not differ significantly between the booster (N = 62) and control condition (N = 64) (B = −2.01, 95% confidence interval (CI) = −4.76 to 0.75). No significant increase in fatigue severity was found at T52 compared with directly post-treatment (T20) in both conditions (B = 0.44, 95% CI = −0.97 to 1.85). Conclusion: Effects of CBT were sustained up to 1 year in both conditions. The booster programme did not significantly improve the long-term outcome of CBT for MS-related fatigue. Trial registration: Dutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782 [ABSTRACT FROM AUTHOR]

Orphans and vulnerable children (OVC) in sub-Saharan Africa are at high risk for HIV infection and transmission. HIV prevention and treatment efforts with OVC are hindered by mental health and substance use problems. This randomized controlled trial compared a mental health intervention, Trauma Focused Cognitive Behavioral Therapy (TF-CBT), to an enhanced version of an existing HIV Psychosocial Counseling (PC+) program among 610 adolescents who met PEPFAR criteria for OVC and had HIV risk behaviors in Lusaka, Zambia. Outcomes included HIV risk behaviors (e.g., risky sexual behaviors), mental health (internalizing symptoms, externalizing behaviors, PTSD) and substance use. At 12-month follow-up, there were significant within group reductions in both groups for all outcomes, with the only significant between group difference being for substance use, in which OVC who received TF-CBT had significantly greater reductions than OVC who received PC+. In a subgroup analysis of OVC with high levels of PTSD symptoms, TF-CBT was superior to PC + in reducing internalizing symptoms, functional impairment, and substance use. Findings support TF-CBT for reducing substance use among OVC. Subgroup analysis results suggest that a robust intervention such as TF-CBT is warranted for OVC with significant mental and behavioral health comorbidities. The similar performance of TF-CBT and PC + in the overall sample for risky sexual behavior and mild mental health problems indicates that enhancing existing psychosocial programs, such as PC, with standard implementation factors like having a defined training and supervision schedule (as was done to create PC+) may improve the efficacy of HIV risk reduction efforts. Clinical Trials Number: NCT02054780 [ABSTRACT FROM AUTHOR]

People with HIV (PHW) are at greater risk of depression than the general population. Insight into the time-to-treatment-response and predictors of response to psychotherapy may improve implementation in primary care. We assessed depression treatment response among 80 participants in a trial of cognitive-behavioral therapy for adherence and depression (CBT-AD) for PWH with MDD and suboptimal antiretroviral therapy (ART) adherence. Participants self-reported depressive symptoms (CES D) at each therapy session. Clinicians assessed participants' depression (HAM D), along with potential predictors of response, every four months for one year. Latent class analyses examined classes of responders for the active and the post-treatment phases. Regression analyses identified predictors of class membership for each phase. During the active treatment phase (CES D) we identified an early response (at session 2 and with continued trajectory of improvement) and a non-response group. There were also two classes during post-treatment (HAM-D): early responders (4-month) and late responders (12-month). Distress aversion was associated with lower likelihood of early response to CBT-AD (aOR = 0.74, 95%CI[0.56–0.90], p =.009), and social support was associated with increased likelihood of early response (aOR = 2.24, 95%CI[1.07–5.46], p =.045). Self-reported depression during the treatment phase may have resulted from social desirability bias. Most participants responded to CBT-AD early during treatment (89 %) and had sustained improvements in depression by 4 months (80 %). Distress aversion was a risk factor for late response, and social support was protective. Future research is needed to assess the optimal dose of CBT-AD in resource limited settings. • Cognitive Behavioural Therapy effectively treats depression and adherence in Persons with HIV. It therefore improves rates of viral suppression, more than treatment as usual. • Early self-reported improvements in depression most likely are the result of being in a trial. Improvement continued to occur throughout the acute treatment phase. • Clinician-rated depression over 4, 8 and 12 months also occurred, with steep improvement seen at 4 months. • Whether or not shorter durations of therapy, delivered by nurses, is effective remains to be explored. [ABSTRACT FROM AUTHOR]

Background and Aims: There is little RCT evidence that brief interventions improve treatment seeking in individuals with severe alcohol use disorder (AUD) or treatment seeking reduces alcohol use. The aim was to test the efficacy of a brief intervention to increase treatment seeking in treatment naïve adults with severe AUD and measure its effects on alcohol use. Design: Parallel group, non‐pharmacologic RCT with intervention (n = 197) and active control (n = 203) conditions, with blinded assessors conducting follow‐ups at 1, 3 and 6 months. Setting: Online recruitment in a 17‐county region of upstate New York, USA. Participants: Inclusion criteria consisted of ages ≥18 years, Alcohol Use Disorders Identification Test score ≥16, exceeds recommended limits for alcohol use and no history of AUD treatment. n = 400; 50% female; 79% white; mean age, 40.7; mean education, 14.6 years. Intervention and comparator: One‐session telephone‐delivered interventions: Cognitive‐Behavioral Therapy for Treatment Seeking (CBT‐TS; intervention), review of a National Institute on Alcohol Abuse and Alcoholism pamphlet on AUD treatment (control). Measurements Self‐report of any AUD treatment use over 3 months (primary outcome) and two standard measures of alcohol use over 6 months (secondary outcomes). Findings Intent‐to‐treat analyses were used. Assessment follow‐up rates were ≥93%. Any alcohol‐related treatment use over 3‐month follow‐up was obtained by 38 (19%) intervention participants and 36 (18%) control participants, a non‐significant difference, χ2 [1] = 0.16, P = 0.689. Secondary analysis showed a significant interaction term between sex and intervention assignment (β = −1.197, P = 0.027). The interaction suggested CBT‐TS was effective in men (22% vs 13%), although the evidence was somewhat weak (P = 0.071), and it was not effective in women (17% vs 24%). Conclusions: A one‐session cognitive‐behavioral therapy intervention to increase treatment seeking in treatment naïve adults with severe alcohol use disorder did not increase treatment seeking. [ABSTRACT FROM AUTHOR]

Background: Postpartum depression (PPD) affects up to one in five mothers and birthing parents, yet as few as 10% access evidence-based treatment. One-day cognitive behavioral therapy (CBT)-based workshops for PPD have the potential to reach large numbers of sufferers and be integrated into stepped models of care. Methods: This randomized controlled trial of 461 mothers and birthing parents in Ontario, Canada with Edinburgh Postnatal Depression Scale (EPDS) scores ⩾10, age ⩾18 years, and an infant <12 months of age compared the effects of a 1-day CBT-based workshop plus treatment as usual (TAU; i.e. care from any provider(s) they wished) to TAU alone at 12-weeks post-intervention on PPD, anxiety, the mother–infant relationship, offspring behavior, health-related quality of life, and cost-effectiveness. Data were collected via REDCap. Results: Workshops led to meaningful reductions in EPDS scores (m = 15.77 to 11.22; b = −4.6, p < 0.01) and were associated with three times higher odds of a clinically significant decrease in PPD [odds ratio (OR) 3.00, 95% confidence interval (CI) 1.93–4.67]. Anxiety also decreased and participants had three times the odds of clinically significant improvement (OR 3.20, 95% CI 2.03–5.04). Participants reported improvements in mother–infant bonding, infant-focused rejection and anger, and effortful control in their toddlers. The workshop plus TAU achieved similar quality-adjusted life-years at lower costs than TAU alone. Conclusions: One-day CBT-based workshops for PPD can lead to improvements in depression, anxiety, and the mother–infant relationship and are cost-saving. This intervention could represent a perinatal-specific option that can treat larger numbers of individuals and be integrated into stepped care approaches at reasonable cost. [ABSTRACT FROM AUTHOR]

Third wave cognitive behavioural therapy has drawn attention to the value of interventions focusing on improved psychological functioning and wellbeing, rather than recovery or absence of disorder alone. The current study compared behavioural therapy combined with either self-compassion training or cognitive therapy (experimental treatment with standard treatment) in a randomized controlled trial for an initial presentation of a depressive disorder or post-traumatic stress disorder at a publicly funded outpatient unit. A battery of reliable and valid scales to assess the severity of the presenting problem and level of self-compassion were administered at both commencement and end of a 12-week treatment intervention. Basic sociodemographic variables were also recorded. Effective randomization was achieved for all variables except self-compassion, for which the standard treatment group reported higher levels than the experimental group. The greater efficacy of the experimental protocol was indicated by significant time by group interactions in severity measures over time in the experimental group relative to the standard group. This study contributes to a relatively fledgling literature on the therapeutic efficacy of self-compassion, providing both researchers and clinicians with valuable insight into the circumstances in which training in self-compassion may be of potential benefit when incorporated into standard practice. The trial was registered with the Australian New Zealand Clinical Trials Registry (TRN 12617000885392, June 16, 2017). [ABSTRACT FROM AUTHOR]

Introduction: Major depressive disorder (MDD) is a highly prevalent and disabling disorder. This study examines two psychotherapy methods for MDD, behavioral activation (BA), and metacognitive therapy (MCT), when applied as outpatient treatments to severely affected patients. Methods: The study was conducted in a tertiary outpatient treatment center. Patients with a primary diagnosis of MDD (N = 122) were included in the intention-to-treat sample (55.7% female, mean age 41.9 years). Participants received one individual and one group session weekly for 6 months (M). Assessments took place at baseline, pretreatment, mid-treatment (3 M), post-treatment (6 M), and follow-up (12 M). The primary outcome was depressive symptomatology assessed by the Hamilton Rating Scale for Depression at 12 M follow-up. Secondary outcomes included general symptom severity, psychosocial functioning, and quality of life. Results: Linear mixed models indicated a change in depressive symptoms (F(2, 83.495) = 12.253, p < 0.001) but no between-group effect (F(1, 97.352) = 0.183, p = 0.670). Within-group effect sizes were medium for MCT (post-treatment: d = 0.610; follow-up: d = 0.692) and small to medium for BA (post-treatment: d = 0.636, follow-up: d = 0.326). In secondary outcomes, there were improvements (p ≤ 0.040) with medium to large within-group effect sizes (d ≥ 0.501) but no between-group effects (p ≥ 0.304). Response and remission rates did not differ between conditions at follow-up (response MCT: 12.9%, BA: 13.3%, remission MCT: 9.7%, BA: 10.0%). The deterioration rate was lower in MCT than in BA (χ21 = 5.466, p = 0.019, NTT = 7.4). Discussion: Both MCT and BA showed symptom reductions. Remission and response rates were lower than in previous studies, highlighting the need for further improvements in adapting/implementing treatments for severely affected patients with MDD. [ABSTRACT FROM AUTHOR]

Children with chronic illness (CI) are at risk for internalizing problems, which reduce their quality of life, hamper treatment, and increase family stress. Accordingly, behavioral interventions are provided at the family level. However, the effects of parental involvement on child outcomes are not consistently beneficial. Therefore, it is relevant to study the working mechanisms. In the present study, we tested child coping and parenting stress as underlying mechanisms of the effect of an intervention for children and an additional group intervention for parents. Data were analyzed from a randomized controlled trial. Families of children with chronic illness (N = 120, child M age = 12.11 years, range 7.98–18.07) participated in a cognitive-behavioral-based group intervention and were randomized in the child-only intervention or parent–child intervention. Primary outcomes were parent- and child-reported internalizing problems, whereas the mediators were the use of child active coping skills and parenting stress. The causal model was tested with multilevel mediation analysis. Active coping skills and parenting stress stood out as significant mediators of the effect of the intervention on parent- and child-reported internalizing behavior (Cohen's d effect size range 0.29–1.57). When parents were involved in the intervention, children increased their use of active coping skills and parents decreased in parenting stress, which in turn improved child internalizing problems. Knowing that coping skills and parenting stress underlie the benefit of involving parents can be used for optimizing interventions for children with CI and addressing the risk of internalizing problems. Highlights: Parental involvement in interventions for children with chronic illness can be beneficial, however explanations are still unclear. In this randomized efficacy trial, child use of active coping skills and parenting stress appeared significant temporal mediators. Parental involvement supported child coping and diminished parenting stress, which in turn decreased child internalizing problems. Interventions for children with internalizing problems might be optimized by focusing on determined active components. [ABSTRACT FROM AUTHOR]

Background: Transdiagnostic group cognitive-behavioral therapy (tCBT) is a delivery model that could help overcome barriers to large-scale implementation of evidence-based psychotherapy for anxiety disorders. The aim of this study was to assess the effectiveness of combining group tCBT with treatment-as-usual (TAU), compared to TAU, for the treatment of anxiety disorders in community-based mental health care. Methods: In a multicenter single-blind, two-arm pragmatic superiority randomized trial, we recruited participants aged 18–65 who met DSM-5 criteria for principal diagnoses of generalized anxiety disorder, social anxiety disorder, panic disorder, or agoraphobia. Group tCBT consisted of 12 weekly 2 h sessions. There were no restrictions for TAU. The primary outcome measures were the Beck Anxiety Inventory (BAI) and clinician severity rating from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) for the principal anxiety disorder at post-treatment, with intention-to-treat analysis. Results: A total of 231 participants were randomized to either tCBT + TAU (117) or TAU (114), with outcome data available for, respectively, 95 and 106. Results of the mixed-effects regression models showed superior improvement at post-treatment for participants in tCBT + TAU, compared to TAU, for BAI [ p < 0.001; unadjusted post-treatment mean (s.d.): 13.20 (9.13) v. 20.85 (10.96), Cohen's d = 0.76] and ADIS-5 [ p < 0.001; 3.27 (2.19) v. 4.93 (2.00), Cohen's d = 0.79]. Conclusions: Our findings suggest that the addition of group tCBT into usual care can reduce symptom severity in patients with anxiety disorders, and support tCBT dissemination in routine community-based care. [ABSTRACT FROM AUTHOR]

Introduction: Psychological adjustment to chronic health conditions is important, as poor adjustment predicts a range of adverse medical and psychosocial outcomes. Psychological treatments demonstrate efficacy for people with chronic health conditions, but existing research takes a disorder-specific approach and they are predominately delivered in face-to-face contexts. The internet and remotely delivered treatments have the potential to overcome barriers to accessing traditional face-to-face treatment. Objective: The current study examined the efficacy and acceptability of an internet-delivered transdiagnostic psychological intervention to promote adjustment to illness, based on cognitive behaviour therapy principles. Methods: In a two-arm randomised controlled trial, participants (n = 676) were randomly allocated to the 8-week intervention or a waitlist control. Treatment included five core lessons, homework tasks, additional resources, and weekly contact with a psychologist. Primary outcomes included depression, anxiety, and disability, assessed at pre-treatment, post-treatment, 3-month follow-up, and 12-month follow-up. Results: The treatment group reported significantly greater improvements in depression (between-groups d = 0.47), anxiety (d = 0.32), and disability (d = 0.17) at post-treatment (all ps <0.001). Improvements were sustained over the 3-month and 12-month follow-ups. High treatment completion rates (69%) and levels of satisfaction (86%) were reported by participants in treatment. The intervention required a mean clinician time of 56.70 min per participant. Conclusions: The findings provide preliminary and tentative support for the potential of internet-delivered transdiagnostic interventions to promote adjustment to chronic health conditions. Further research using robust control groups, and exploring the generalisability of findings, is needed before firm conclusions can be drawn. [ABSTRACT FROM AUTHOR]

Background: More than half of the adults with visual impairment experience severe symptoms of fatigue, with a negative impact on daily life. Since there is no evidence-based treatment to reduce fatigue in adults with visual impairment, we developed E-nergEYEze, an eHealth intervention based on cognitive behavioral therapy and self-management tailored to the needs of visually impaired adults. The aim is to describe the study protocol of a randomized controlled trial testing E-nergEYEze.Methods: A randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of E-nergEYEze to reduce fatigue severity compared to care as usual from a healthcare and societal perspective. A total of 172 severely fatigued adults with visual impairment will be recruited and randomized to either the E-nergEYEze intervention plus care as usual or to care as usual only (ratio 1:1). Inclusion criteria are having a visual impairment, experiencing severe fatigue (Checklist Individual Strength - subscale Fatigue Severity: CIS-FS > 35), being 18 years or older, understanding the Dutch language, and having access to the internet. The intervention consists of one face-to-face session and a computer training followed by internet-based modules with information and assignments on coping with fatigue. During this 5-month intervention, participants will be digitally supported by a social worker. All measurements will be administered at baseline, after 6 and 12 months, and additionally, those related to cost-effectiveness at 3 and 9 months. The primary outcome is fatigue severity (CIS-FS).Discussion: Severe fatigue on top of visual impairment compromises quality of life and is associated with incremental societal costs that largely determine the economic burden of low vision or blindness. E-nergEYEze contributes to the evidence base of potentially feasible interventions to reduce the important health-related consequences of vision loss and could fulfill the gap in knowledge, skills and treatment options for low vision services.Trial Registration: Dutch Trial Register NTR7764 . Registered on 28 May 2019. [ABSTRACT FROM AUTHOR]

• A newly developed protocol for CBT of driving fear is feasible and accepted. • CBT was significantly more efficacious than the wait list. • Large effect sizes are found on the Instrument for Fear of Driving. • Also lager effect sizes are found on the Driving Cognitions Questionnaire. Fear of driving is common in clinical practice, while its treatment programs are understudied. This is the first randomized controlled trial to evaluate a newly developed protocol for cognitive behavior therapy (CBT) for driving fear compared with a wait list and to use specific assessment scales. 34 participants (30 women, 4 men) in an outpatient psychotherapy clinic were randomly allocated to either 18 sessions of CBT or a wait list (n = 17 each). After treatment, CBT was significantly more efficacious than the wait list with large effect sizes on the Instrument for Fear of Driving (IFD) (Cohen's d = 2.58) and on the Driving Cognitions Questionnaire (DCQ) (Cohen's d = 2.14). Driving fear is a condition treatable by CBT and the suggested protocol is safe, feasible and acceptable. Further studies with larger samples and active controls (e.g., virtual reality therapy) are required to draw generalizable conclusions on effect sizes. [ABSTRACT FROM AUTHOR]

Introduction: Major depressive disorder, highly prevalent among people with HIV (PWH) globally, including South Africa, is associated with suboptimal adherence to antiretroviral therapy. Globally, there are insufficient numbers of mental health providers and tested depression treatments. This study's aim was to test task‐shared cognitive‐behavioural therapy for adherence and depression (CBT‐AD) in HIV, delivered by clinic nurses in South Africa. Methods: This was a two‐arm randomized controlled effectiveness trial (recruitment: 14 July 2016 to 4 June 2019, last follow 9 June 2020). One‐hundred‐sixty‐one participants with clinical depression and virally uncontrolled HIV were recruited from primary care clinics providing HIV care, in Khayelitsha, South Africa. Arm 1 was task‐shared, nurse‐delivered CBT‐AD; and arm 2 was enhanced treatment as usual (ETAU). Primary outcomes (baseline to 4 months) were blinded Hamilton Depression Rating Scale (HAM‐D) scores, and weekly adherence via real‐time monitoring (Wisepill). Secondary outcomes were adherence and depression over 4‐, 8‐ and 12‐month follow‐ups, proportion of participants with undetectable viremia and continuous CD4 cell counts at 12 months. Additional analyses involved viral load and CD4 over time. Results: At 4 months, the HAMD scores in the CBT‐AD condition improved by an estimated 4.88 points more (CI: –7.86, –1.87, p = 0.0016), and for weekly adherence, 1.61 percentage points more per week (CI: 0.64, 2.58, p = 0.001) than ETAU. Over follow‐ups, CBT‐AD had an estimated 5.63 lower HAMD scores (CI: –7.90, –3.36, p < 0.001) and 23.56 percentage points higher adherence (CI: 10.51, 34.21, p < 0.001) than ETAU. At 12 months, adjusted models indicated that the odds of having an undetectable viremia was 2.51 greater at 12 months (CI: 1.01, 6.66, p = 0.047), and 3.54 greater over all of the follow‐ups (aOR = 3.54, CI: 1.59, 20.50; p = 0.038) for those assigned CBT‐AD. CD4 was not significantly different between groups at 12 months or over time. Conclusions: Task‐shared, nurse‐delivered, CBT‐AD is effective in improving clinical depression, ART adherence and viral load for virally unsuppressed PWH. The strategy of reducing depression to allow patients with self‐care components of medical illness to benefit from adherence interventions is one to extend. Implementation science trials and analyses of cost‐effectiveness are needed to translate findings into clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT02696824 https://clinicaltrials.gov/ct2/show/NCT02696824 [ABSTRACT FROM AUTHOR]

Objectives: The Bipolar at Risk Trial (BART) was a feasibility randomized controlled trial investigating cognitive behavioral therapy (CBT) compared with treatment as usual (TAU) in young people at high risk of developing bipolar disorder (BD). This qualitative study aimed to investigate participants' experiences of trial involvement, and the acceptability of CBT for this population. Design: Participants were those identified as being at risk of bipolar disorder, determined by current symptoms or family history. A purposive sample of twenty‐one participants from both the intervention and TAU arms of the trial was recruited. Methods: Twenty‐one semi‐structured interviews were conducted by service user researchers (13 participants had received therapy and 8 TAU). Interviews were audio recorded with consent from participants and transcribed verbatim. NVivo 11 Pro software was used to conduct an inductive thematic analysis. Results: Super‐ordinate themes were "adaptability and flexibility," "feeling understood and valued," and "relevance of study and intervention" which had two sub‐themes—"value of the trial therapy" and "acceptability of trial processes." Participating in the trial and having therapy enabled participants to feel understood and valued by research assistants (RAs) and therapists. Participants viewed therapy as relevant to their current concerns and valued adaptability and flexibility of RAs and therapists. Conclusions: Findings highlight the importance and value of flexibility, adaptability, and understanding in relationships between participants and trial staff. Findings also indicate that the trial processes and CBT focusing on mood swings are acceptable and relevant to participants from this at risk population. Practitioner points: Young people at risk of bipolar disorder value a flexible approach to assessments and therapy, developing a rapport with research assistants and therapists and opening up to them when they feel comfortable to do so.CBT focusing on coping with mood swings was acceptable to the majority of participants who received it and it was perceived as helpful in ways that were personal to each participant. [ABSTRACT FROM AUTHOR]

Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as cognitive behavior therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through virtual reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery.Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. [ABSTRACT FROM AUTHOR]

Background: Alcohol and other drug use disorders contribute substantially to the global burden of illness. The majority of people with substance use disorders do not receive any treatment for their problems, and developing treatments that are attractive and effective to patients should be a priority. However, whether treatment is best delivered in a group format or an individual format has only been studied to a very limited degree. The COMDAT (Combined Drug and Alcohol Treatment) trial evaluates the feasibility, acceptability, and cost effectiveness of MOVE group (MOVE-G) treatment versus MOVE individual (MOVE-I) treatment in four community-based outpatient treatment centres in Denmark.Methods: A two-arm non-inferiority trial comparing MOVE-I (Pedersen et al., Drug Alcohol Depend 218:108363, 2020) with MOVE-G a combined group treatment for both alcohol use disorder and drug use disorder. The primary objective is to examine whether MOVE-G is non-inferior to MOVE-I in relation to abstinence from drug and/or alcohol, number of sessions received, and completion of treatment as planned. All participants will receive treatment based on cognitive behavioral therapy and motivational interviewing, vouchers for attendance and text reminders, as well as medication as needed (MOVE). Participants (n = 300) will be recruited over a one-year period at four public treatment centers in four Danish municipalities. A short screening will determine eligibility and randomization status. Hereafter, participants will be randomized to the two treatment arms. A thorough baseline assessment will be conducted approximately 1 week after randomization. Follow-up assessments will be conducted at 9 months post-randomization. In addition, patients' use of drugs and alcohol, and patients' wellbeing will be measured in all sessions. The main outcome measures are drug and alcohol intake at 9 months follow-up, number of sessions attended, and dropout from treatment.Discussion: The present study will examine the potential and efficacy of combined groups (patients with alcohol and drug disorders in the same group) versus individually based treatment both based on the treatment method MOVE (Pedersen et al., Drug Alcohol Depend 218:108363, 2020).Trial Registration: ISRCTN88025085 , registration date 30/06/2020. [ABSTRACT FROM AUTHOR]

Online treatment delivery has the potential to increase access to evidence-based mental health care for children with anxiety disorders. Using a randomized controlled trial design, we evaluated the efficacy of Cool Kids Online, a family-based and therapist supported internet-delivered cognitive behavioral treatment (CBT) designed to target anxiety disorders in children. Ninety-five children aged 7–12 years with a DSM-5 anxiety disorder were randomly allocated to Cool Kids Online or a waitlist control. Children were assessed at baseline, week 11, and 6-months following treatment. Children in waitlist received treatment after week 11 and also completed assessments immediately and six months after treatment, allowing treatment maintenance to be evaluated for all children. Compared to waitlist, Cool Kids Online led to significantly greater remission of anxiety disorders (primary and all anxiety diagnoses) and greater reduction of caregiver-reported anxiety symptoms and interference at week 11. Child-reported anxiety symptoms and interference and child- and caregiver-reported depressive or externalizing symptoms did not differ significantly between conditions. Medium to large within-treatment effects were observed for all children from pre to post treatment with post treatment effects maintained until follow-up. Overall, the findings provide support for the efficacy of the program in treating anxiety. Cool Kids Online compared to waitlist for the remission of anxiety disorders in clinically anxious children; anzctr.org.au ; ACTRN12615000947505. • Online family-based cognitive behaviour therapy reduces child anxiety disorders. • Therapist support during online child anxiety programs may be important for change. • Cool Kids Online is a promising method to improve access to child anxiety treatment. [ABSTRACT FROM AUTHOR]

Objective: Problem gambling can cause severe harm to concerned significant others (CSOs) in the form of, for example, relationship problems, financial difficulties, and mental and physical illness. CSOs are important for their ability to support problem gamblers and motivate them to change. This study investigated the effect of an Internet-based intervention for CSOs of treatment-refusing problem gamblers on (a) gambling-related harm, (b) the gamblers' treatment-seeking rate, and (c) the relationship satisfaction and mental health of the CSOs. Method: A total of 100 CSOs of problem gamblers were randomized into one of two conditions: Internet-delivered cognitive- behavioral therapy for CSOs or a wait-list control group. The intervention group was given Internet-based treatment consisting of nine modules with therapist support available via telephone and e-mail. Outcome measures were collected up 12 months posttreatment. Results: The intervention improved the psychological well-being of the CSOs compared to the wait-list group at the posttest (CSO's emotional consequences: d = -0.90, 95% CI [-1.47, -0.33]; relationship satisfaction: d = 0.41, 95% CI [0.05, 0.76]; anxiety: d = -0.45, 95% CI [-0.81, -0.09]; depression: d = -0.49, 95% CI [-0.82, -0.16]). However, the effects on the gambling outcomes were small and inconclusive (gambling losses: multiplicative effect - 0.73, 95% CI [0.29, 1.85]; treatment-seeking: hazard ratio - 0.86, 95% CI [0.31, 2.38]). Conclusion: The results confirm earlier studies' findings that affecting the gambler via a CSO is challenging, but it is possible to increase the CSO's coping and well-being. The trial's outcome data and scripts are available for download (https://osf.io/awtg7/) [ABSTRACT FROM AUTHOR]

Introduction: Evidence from developed countries shows the efficacy of computer-assisted cognitive-behavioral therapy (cCBT) in addressing adolescent depression in home and/or school settings. This paper presents the results of a randomized controlled trial (RCT) of a brief therapist-guided cCBT intervention for adolescent depression in resource-constrained primary health care (PHC) settings. Material and methods: A multicenter, two-arm parallel-group, individually RCT with a 1:1 allocation ratio assigned 216 depressed adolescents (aged 15–19) attending four PHC centers in a low-income municipality of Santiago, Chile, to receive eight weekly face-to-face therapist-guided cCBT sessions by study therapists (N = 108), or to receive an enhanced usual care (EUC) intervention by trained PHC psychologists, encouraged to adhere to the national clinical guidelines for the management of depression (N = 108). Both groups received pharmacotherapy concordant with these guidelines. The primary outcome was the Beck Depression Inventory (BDI) at 4 months post-randomization, to assess depressive symptoms. BDI at 6 months post-randomization was a secondary outcome. Additional measures included patients' compliance, and satisfaction with different treatment components, at 6 months post-randomization. Main Results: The adjusted difference in mean BDI score between groups was -3.75 (95% CI -6.23 to -1.28; p = 0.003) at 4 months post-randomization. At 6 months post-randomization, the adjusted difference in mean BDI score between groups was -2.31 (95% CI -4.89 to 0.27; p = 0.078). The effect size was small-to-medium at 4 months post-randomization, d = 0.39 (0.12 to 0.67), and small and non-significant at 6 months post-randomization d = 0.29 (-0.00 to 0.59). Adolescents in the experimental treatment group were significantly more satisfied with treatment, with the PHC centers' facilities, with the psychological care received, and with non-professional staff than those in the comparator treatment group. Discussion: A brief therapist-guided cCBT eight-session intervention improves the response of depressed adolescents attending PHC centers at 4 months post-randomization. At 6 months post-randomization, the differences of between groups were not significant. Future research may focus on exploring strategies to sustain and increase response. Clinical trial registration: www.ClinicalTrials.gov , identifier NCT01862913 and URL: https://clinicaltrials.gov/ct2/show/NCT01862913. [ABSTRACT FROM AUTHOR]

Background: Psychotherapeutic research on inflammatory bowel disease (IBD) is of particular importance to licensed clinical social workers since they represent the biggest source of mental health providers in the United States. Objective: The purpose of the present meta-analysis is to determine the depression, anxiety, and quality of life (QOL) summary effects of experimental CBT studies for adults with IBD and to discuss specific implications for clinical social work practice. Methods: In March 2018 a systematic review was completed via searching online databases and the reference lists of included studies. To include the maximum number of articles which met inclusion criteria, temporal constraints were not used in the database searches. Results: The random-effects model meta-analysis found a small (Hedges' g = −0.35), statistically significant reduction in depression among persons who were treated with CBT and small, statistically insignificant effects regarding anxiety (Hedges' g = −0.24) and QOL (Hedges' g = −0.15). All of the summary effects were ultimately homogenous. Discussion: Discussion pertaining to limitations, strengths, implications for clinical social workers, and areas of future research is provided. [ABSTRACT FROM AUTHOR]

Objective: Cognitive‐behavior therapy (CBT) is considered the "golden standard" psychotherapy for generalized anxiety disorder (GAD) but, at this point, we have little information about differences among various CBT approaches. Method: We conducted a randomized controlled trial to compare three CBT protocols for GAD: (a) Cognitive Therapy/Borkovec's treatment package; (b) Rational Emotive Behavior Therapy, and (c) Acceptance and Commitment Therapy/Acceptance‐based behavioral therapy. A number of 75 patients diagnosed with GAD, aged between 20 and 51 (m = 27.13; standard deviation = 7.50), 60 women and 11 men, were randomized to the three treatment arms. Results: All treatments were associated with large pre‐post intervention reductions in GAD symptoms and dysfunctional automatic thoughts, with no significant differences between groups. Correlation analyses showed similar associations between changes in symptoms and changes in dysfunctional automatic thoughts. Conclusions: All three approaches appear to be similarly effective. Implications for the theoretical models underlying each of the three cognitive‐behavior therapy approaches are discussed. [ABSTRACT FROM AUTHOR]

Background: Blended cognitive behaviour therapy (bCBT) is an effective treatment for fear of cancer recurrence (FCR) in curatively-treated breast, colorectal and prostate cancer survivors with high FCR. However, long-term outcomes are unknown. This study investigated the long-term efficacy and cost-effectiveness of bCBT compared with care as usual (CAU).Methods: Eighty-eight cancer survivors with high FCR (Cancer Worry Scale ≥14) were randomly assigned to bCBT (n = 45) or CAU (n = 43). Data were collected at baseline and at three, nine and fifteen months from baseline and analysed by modified intention-to-treat. Efficacy was investigated with linear mixed-effects models. Cost-effectiveness was investigated from a societal perspective by comparing costs with quality-adjusted life-years (QALYs).Results: Participants who received bCBT reported significantly lower FCR compared with CAU (mean difference of - 1.787 [95% CI -3.251 to - 0.323, p = 0.017] at 15 months follow-up), and proportionally greater self-rated and clinically significant improvement at each follow-up measurement. Total QALYs were non-significantly different between conditions when adjusted for utility score baseline differences (0.984 compared to 0.957, p = 0.385), while total costs were €631 lower (95% CI -1737 to 2794, p = 0.587). Intervention costs of bCBT were €466. The incremental cost-effectiveness ratio amounted to an additional €2049 per QALY gained, with a 62% probability that bCBT is cost-effective at a willingness to pay (WTP) threshold of €20,000 per QALY. Results were confirmed in sensitivity analyses.Conclusions: bCBT for cancer survivors with FCR is clinically and statistically more effective than CAU on the long-term. In addition, bCBT is a relatively inexpensive intervention with similar costs and QALYs as CAU.Trial Registration: The RCT was registered in the Dutch National Trial Register ( NTR4423 ) on 12-Feb-2014. This abstract was previously presented at the International Psycho-Oncology Society conference of 2018 and published online. (Psycho-oncology, 27(S3):8-55; 2018). [ABSTRACT FROM AUTHOR]

Up to one-third of individuals with obsessive-compulsive disorder (OCD) do not benefit from evidence-based psychotherapy. We examined the efficacy of mindfulness-based cognitive therapy (MBCT) as a complementary treatment option. In a prospective, bicentric, assessor-blinded, randomized, and actively controlled clinical trial, 125 patients with OCD and residual symptoms after cognitive behavioral therapy (CBT) were randomized to either an MBCT group (n = 61) or to a psychoeducational group (OCD-EP; n = 64) as an active control condition. At post-treatment, there was no significant benefit of MBCT over OCD-EP with the Yale-Brown-Obsessive-Compulsive Scale (Y-BOCS) as the primary outcome measure, but with the Obsessive-Compulsive Inventory [OCI-R; F(1, 101) = 5.679, p = .036, effect size η2partial = 0.053]. Moreover, the response rate and the improvement on secondary outcomes such as obsessive beliefs and quality of life was significantly larger in the MBCT group. Non-completion rates were below 10%. At the 6-month follow-up, OC symptoms were further improved in both groups; group differences were no longer significant. Our findings suggest that MBCT, compared to a psychoeducational program, leads to accelerated improvement of self-reported OC symptoms and secondary outcomes, but not of clinician-rated OC symptoms. In the midterm, both interventions yield similar and stable, but small improvements, suggesting that additional treatment options may be necessary. [ABSTRACT FROM AUTHOR]

Introduction: Thalassemia is a chronic hereditary anemia which can be associated with different psychological, emotional, and behavioral problems such as depression and anxiety. This study aimed to evaluate the effects of cognitive behavioral therapy on depression and anxiety of patients with thalassemia. Methods: This was a randomized controlled trial study. A total of 76 patients were randomly allocated to an experimental (n=38) and a control group (n=38). Patients in the experimental group were provided with cognitive behavioral therapy while their counterparts in the control group received routine care services. Depression and anxiety assessments were performed four weeks before the intervention as well as four and six weeks after that. Between-group and within-group comparisons were performed through the independent-sample t-tests and the paired sample t-test, respectively Results: The post-test mean score of anxiety in the experimental group was significantly lower than that for the control group, while there was no significant difference between the groups regarding the post-test mean score of depression. The mean score of depression in both study groups decreased significantly. The rate of decrease in the experimental group was significantly greater than that in the control group. Conclusion: Cognitive behavioral therapy can be used to prevent or alleviate depression and anxiety among patients. [ABSTRACT FROM AUTHOR]

Background: Fatigue is a common symptom in multiple sclerosis (MS) and often restricts societal participation. Cognitive behavioral therapy (CBT) may alleviate MS-related fatigue, but evidence in literature is inconclusive. Objective: To evaluate the effectiveness of CBT to improve MS-related fatigue and participation. Methods: In a multi-center, assessor-masked, randomized controlled trial, participants with severe MSrelated fatigue were assigned to CBT or control treatment. CBT consisted of 12 individual sessions with a psychologist trained in CBT, the control treatment consisted of three consultations with a MS nurse, both delivered over 16 weeks. Assessments were at baseline, 8, 16 (i.e. post-intervention), 26, and 52 weeks post-baseline. Primary outcomes were the Checklist Individual Strength-fatigue subscale (CIS20r fatigue) and the Impact on Participation and Autonomy questionnaire (IPA). Data were analyzed according to the intention-to-treat principle, using mixed-model analysis. Results: Between 2011 and 2014, 91 patients were randomized (CBT: n = 44; control: n = 47). Betweengroup analysis showed a positive post-intervention effect for CBT on CIS20r fatigue (T16: -6.7 (95% confidence interval (CI) = -10.7; -2.7) points) that diminished during follow-up (T52: 0.5 (95% CI = -3.6; 4.4)). No clinically relevant effects were found on societal participation. Conclusion: Severe MS-related fatigue can be reduced effectively with CBT in the short term. More research is needed on how to maintain this effect over the long term. [ABSTRACT FROM AUTHOR]

Background: Substance use in pregnancy is associated with severe maternal and fetal morbidities and substantial economic costs. However, few studies have evaluated the cost-effectiveness of substance use treatment programs in pregnant women. The purpose of this study was to evaluate the economic impact of a behavioral intervention that integrated motivational enhancement therapy with cognitive behavioral therapy (MET-CBT) for treatment of substance use in pregnancy, in comparison with brief advice.Methods: We conducted an economic evaluation alongside a clinical trial by collecting data on resource utilization and performing a cost minimization analysis as MET-CBT and brief advice had similar effects on clinical outcomes (e.g., alcohol and drug use and birth outcomes). Costs were estimated from the health care system's perspective and included intervention costs, hospital facility costs, physician fees, and costs of psychotropic medications from the date of intake assessment until 3-month postpartum. We compared effects of MET-CBT on costs with those of brief advice using Wilcoxon rank sum tests.Results: Although the integrated MET-CBT therapy had higher intervention cost than brief advice (median = $1297/participant versus $303/participant, p < 0.01), costs of care during the prenatal period, delivery, and postpartum period, as well as for psychotropic medications, were comparable between the two groups (all p values ≥ 0.55). There was no statistically significant difference in overall cost of care (median total cost = $26,993/participant for MET-CBT versus $27,831/participant for brief advice, p = 0.90).Conclusions: The MET-CBT therapy and brief advice resulted in similar clinical outcomes and overall medical costs. Further research incorporating non-medical costs, targeting women with more severe substance use disorders, and evaluating the impact of MET-CBT on participants' quality of life will provide additional insights.Trial Registration: ClinicalTrials.gov NCT00227903 . Registered 27 September 2005. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) is associated with hypoactivation of the dorsolateral prefrontal cortex, a brain region involved in emotion regulation and basic cognitive control processes. Recent studies have indicated that computerized interventions designed to activate this region may reduce depressive and ruminative symptoms. In this double-blind randomized controlled trial, we tested whether one such program, called Cognitive Control Training (CCT), enhanced treatment outcomes when used in adjunct to brief behavior therapy for MDD.Methods: Thirty-four adults with MDD were randomly assigned to complete four sessions of either computerized CCT or a control task, concurrently with four sessions of Brief Behavioral Activation Therapy for Depression (BATD). Post-treatment and one-month follow-up assessments were conducted, with self-reported depressive symptoms as the primary outcome and clinician-rated depressive symptoms and self-reported rumination as secondary outcomes.Results: In both intent-to-treat and completer analyses, depressive symptoms and rumination decreased significantly over the course of treatment in both treatment conditions. There were no significant differences in treatment outcome depending on the augmentation condition.Limitations: The sample size was small, hindering secondary analyses and identification of potential predictors or moderators of treatment effect.Conclusions: Results demonstrate substantial clinical benefit following four sessions of BATD; however, adjunctive CCT did not enhance outcomes. This study and other recent research suggest that the effects of CCT may not be as robust as previously indicated, highlighting the need for continued investigation of the conditions under which CCT may be effective. [ABSTRACT FROM AUTHOR]

Insomnia has been frequently reported as one of the most burdensome symptoms among cancer survivors. To date, little research exists on strategies to effectively reduce insomnia in cancer survivors, especially in the application of cognitive behavioral therapy for insomnia (CBTI) at the bedside by nurses. The current objective is to determine efficacy and durability of a streamlined, individually delivered version of CBTI, specifically Brief Behavioral Therapy for Insomnia (BBTI) versus a healthy eating attention control, using a large heterogeneous sample of 158 cancer survivors. Study participants will be adults ≥18 years of age; ≥1 month from treatment (except hormones and targeted therapies are acceptable) for stages I through III breast, colorectal, lung or prostate cancers; meet criteria for insomnia defined by Insomnia Severity Index (ISI) >7; screen negative for obstructive sleep apnea <15 events/h; and ability to complete data collection instruments in English. Baseline, and then 1-, 3-, and 12-month objective (i.e., actigraphy) and subjective sleep, mood, and quality of life assessments after the interventions are planned. The primary outcome will be measured with the ISI, a psychometrically-sound instrument used to measure perceived insomnia severity. The results of this trial will demonstrate the application of BBTI in a larger heterogenous sample of cancer survivors for the first time and may lead to implementation strategies that will promote the dissemination and sustainability of this intervention. Clinical trials identifier: http://ClinicalTrials.gov , NCT03810365 [ABSTRACT FROM AUTHOR]

Background: Social anxiety disorder (SAD) with comorbid avoidant personality disorder (APD) has a high prevalence and is associated with serious psychosocial problems and high societal costs. When patients suffer from both SAD and APD, the Dutch multidisciplinary guidelines for personality disorders advise offering prolonged cognitive behavioral therapy (CBT). Recently there is increasing evidence for the effectiveness of schema therapy (ST) for personality disorders such as borderline personality disorder and cluster C personality disorders. Since ST addresses underlying personality characteristics and maladaptive coping strategies developed in childhood, this treatment might be particularly effective for patients with SAD and comorbid APD. To our knowledge, there are no studies comparing CBT with ST in this particular group of patients. This superiority trial aims at comparing the effectiveness of these treatments. As an additional goal, predictors and underlying mechanisms of change will be explored. Methods/design: The design of the study is a multicentre two-group randomized controlled trial (RCT) in which the treatment effect of group cognitive behavioral therapy (GCBT) will be compared to that of group schema therapy (GST) in a semi-open group format. A total of 128 patients aged 18-65 years old will be enrolled. Patients will receive 30 sessions of GCBT or GST during a period of approximately 9 months. Primary outcome measures are the Liebowitz Social Anxiety Scale Self-Report (LSAS-SR) for social anxiety disorder and the newly developed Avoidant Personality Disorder Severity Index (AVPDSI) for avoidant personality disorder. Secondary outcome measures are the MINI section SAD, the SCID-II section APD, the Schema Mode Inventory (SMI-2), the Inventory of Depressive Symptomatology Self- Report (IDS-SR), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Difficulties in Emotion Regulation Scale (DERS), the Rosenberg Self-Esteem Scale (RSES) and the Acceptance and Action Questionnaire (AAQII). Data will be collected at the start, halfway and at the end of the treatment, followed by measurements at 3, 6 and 12 months post-treatment. Discussion: The trial will increase our knowledge on the effectiveness and applicability of both treatment modalities for patients suffering from both diagnoses. Trial registration: Dutch Trial Register: NTR3921. Registered on 25 March 2013. [ABSTRACT FROM AUTHOR]

Objectives To test a new cognitive behavioral therapy for insomnia ( CBT-I) program designed for use by nonclinicians. Design Randomized controlled trial. Setting Department of Veterans Affairs healthcare system. Participants Community-dwelling veterans aged 60 and older who met diagnostic criteria for insomnia of 3 months duration or longer (N = 159). Intervention Nonclinician 'sleep coaches' delivered a five-session manual-based CBT-I program including stimulus control, sleep restriction, sleep hygiene, and cognitive therapy (individually or in small groups), with weekly telephone behavioral sleep medicine supervision. Controls received five sessions of general sleep education. Measurements Primary outcomes, including self-reported (7-day sleep diary) sleep onset latency ( SOL-D), wake after sleep onset ( WASO-D), total wake time ( TWT-D), and sleep efficiency ( SE-D); Pittsburgh Sleep Quality Index ( PSQI); and objective sleep efficiency (7-day wrist actigraphy, SE-A) were measured at baseline, at the posttreatment assessment, and at 6- and 12-month follow-up. Additional measures included the Insomnia Severity Index ( ISI), depressive symptoms (Patient Health Questionnaire-9 ( PHQ-9)), and quality of life (Medical Outcomes Study 12-item Short-form Survey version 2 ( SF-12v2)). Results Intervention subjects had greater improvement than controls between the baseline and posttreatment assessments, the baseline and 6-month assessments, and the baseline and 12-month assessments in SOL-D (−23.4, −15.8, and −17.3 minutes, respectively), TWT-D (−68.4, −37.0, and −30.9 minutes, respectively), SE-D (10.5%, 6.7%, and 5.4%, respectively), PSQI (−3.4, −2.4, and −2.1 in total score, respectively), and ISI (−4.5, −3.9, and −2.8 in total score, respectively) (all P < .05). There were no significant differences in SE-A, PHQ-9, or SF-12v2. Conclusion Manual-based CBT-I delivered by nonclinician sleep coaches improves sleep in older adults with chronic insomnia. [ABSTRACT FROM AUTHOR]

Binge-eating disorder (BED) is a prevalent health condition associated with obesity. Few people with BED receive appropriate treatment. Personal barriers include shame, fear of stigma, geographic distance to mental health services, and long wait-lists. The aims of this study were to examine the efficacy of an Internet-based cognitive-behavioral intervention for adults with threshold BED (DSM-IV) and to examine the stability of treatment effects over 12months. Participants were randomly assigned to a 16-week Internet-based cognitive-behavioral intervention (n=69) or a wait-list condition (n=70). Binge-eating frequency and eating disorder psychopathology were measured with the Eating Disorder Examination-Questionnaire and the Eating Disorder Examination administered over the telephone. Additionally, body weight and body mass index, depression, and anxiety were assessed before and immediately after treatment. Three-, 6-, and 12-month follow-up data were recorded in the treatment group. Immediately after the treatment the number of binge-eating episodes showed significant improvement (d=1.02, between group) in the treatment group relative to the wait-list condition. The treatment group had also significantly reduced symptoms of all eating psychopathology outcomes relative to the wait-list condition (0.82≤d≤1.11). In the treatment group significant improvement was still observed for all measures 1year after the intervention relative to pretreatment levels. The Internet-based intervention proved to be efficacious, significantly reducing the number of binge-eating episodes and eating disorder pathology long term. Low-threshold e-health interventions should be further evaluated to improve treatment access for patients suffering from BED. [ABSTRACT FROM AUTHOR]

Background: Many people living with HIV suffer from depressive symptoms. In a previous pilot study, self-help cognitive behavioral therapy (in booklet format) was found to be effective in treating depressive symptoms in people with HIV. We developed an online self-help program in Dutch and English (based on the booklet) for people with HIV and depressive symptoms. Besides the main question regarding the effectiveness of the program aimed at lowering depressive symptoms, sub-questions will focus on the moderators of treatment success (for which patients is the program especially beneficial?) and the mechanisms of change underlying the treatment outcome (which mediators affect the outcome of treatment?). In this paper, the protocol of the study will be described.Methods/design: The effectiveness of the program will be investigated by comparing the intervention group with a waiting list-control group in a randomized controlled design, by including a pretest and three post-tests. The self-help program contains four main components: activation, relaxation, changing maladaptive cognitions, and goal attainment. Participants with mild to moderate depressive symptoms will work on the program for 6 to 10 weeks, during which a coach will provide motivational support by telephone once a week. Participants in the control condition will receive weekly minimal support from a coach for 8 weeks, and after the second post-test, they can gain access to the self-help program. Depressive symptoms and possible mediators (e.g., activation, cognitive coping, self-efficacy, and goal adjustment) will be assessed by self-report three times during the intervention/waiting period and at the pretest and first post-test.Discussion: The proposed study aims to evaluate the effectiveness of an online self-help intervention for people with HIV and depressive symptoms. If the intervention is shown to be effective, the program will be implemented. Consequently, many patients with HIV could be reached, and their psychological care may be improved.Trial Registration: Netherlands Trial Register: NTR5407. [ABSTRACT FROM AUTHOR]

Cognitive remediation (CR) has been found to improve cognitive performance among adults with schizophrenia in randomized controlled trials (RCTs). However, improvements in cognitive performance are often observed in the control groups of RCTs as well. There has been no comprehensive examination of change in control groups for CR, which may inform trial methodology and improve our understanding of measured outcomes for cognitive remediation. In this meta-analysis, we calculated pre-post change in cognitive test performance within control groups of RCTs in 32 CR trials (n = 794 participants) published between 1970 and 2011, and examined the association between pre-post change and sample size, duration of treatment, type of control group, and participants' age, intelligence, duration of illness, and psychiatric symptoms. Results showed that control groups in CR trials showed small effect size changes (Cohen's d = 0.12 ± 0.16) in cognitive test performance over the trial duration. Study characteristics associated with pre-post change included participant age and sample size. These findings suggest attention to change in control groups may help improve detection of cognitive remediation effects for schizophrenia. [ABSTRACT FROM AUTHOR]

Objective.--To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Background.--Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. Methods.--We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n544) or specialized headache treatment alone (n539). The primary treatment outcome was headache days. Results.--Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136)519.70, P< .001). However, there was no statistically significant difference between the Internet CBT group and the specialized headache treatment group at post-treatment or follow-up (group 3 time interaction F(2, 134)50.94, P5.395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both groups demonstrated statistically significant improvement headache pain intensity, activity limitations, depressive symptoms, and parent protective behaviors from baseline to post-treatment and these gains were maintained at 3-month follow-up. Adolescent anxiety symptoms and sleep did not change during the study period for either group. There were no statistically significant group differences on any secondary outcomes at post-treatment or follow-up (P> .05 for all outcomes). No adverse events were reported. Conclusion.--Although adjunctive Internet CBT did not lead to additional benefit in this population, future research should evaluate whether it is an effective intervention for adolescents with headache who are unable to access specialized headache treatment. [ABSTRACT FROM AUTHOR]

Background: A greater proportion of drug dependent women are victims of intimate partner violence (IPV) than women in the general population; however, few interventions have been developed to reduce IPV among drug dependent women. Methods: An adapted version of the Women's Wellness Treatment, to address IPV and depressive symptoms, was piloted in a randomized controlled trial conducted in outpatient treatment program in Barcelona, Spain among 14 women receiving outpatient treatment for a drug use disorder who screened positive for IPV in the previous month. Participants were randomly assigned to receive the 10 session cognitive behavioral therapy (IPaViT-CBT) group intervention or treatment as usual. The frequency of IPV, depressive symptoms, substance use, quality of life and health status were assessed at baseline and 1, 3 and 12 months post intervention. Intention to treat analysis was performed. Results: Moderate effects for the intervention were found in reducing psychological maltreatment, increasing assertiveness of IPV and reducing aggressiveness in the partner relationship, and in reducing the frequency of drinking up to 3 months post intervention. The intervention did not significantly reduce the likelihood of any IPV, depressive symptoms, quality of life or self-reported health status, up to 12-months post intervention. Conclusion: This pilot trial suggests some initial support for the 10-session CBT group intervention among IPV victims who received treatment for drug use. Study findings indicate that it is feasible to deliver the intervention in a community substance abuse center. An adequately powered trial is required to replicate these results. [ABSTRACT FROM AUTHOR]

Objective: Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. Method: The current study (N = 87) was a 3-arm randomized clinical trial comparing CBT, acceptance and commitment therapy (ACT), and a wait-list control group (WL) in participants with a diagnosis of social phobia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994). Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and posttreatment, and participants assigned to CBT and ACT also completed assessments 6 and 12 months following baseline. Assessments consisted of self-report measures, a public-speaking task, and clinician ratings. Results: Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public-speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-month follow-up in CBT compared with ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Conclusions: Implications for clinical practice and future research are discussed. [ABSTRACT FROM AUTHOR]

Abstract: Integrated psychological treatment addressing co-existing alcohol misuse and depression has not been compared with single-focused treatment. This trial evaluates changes over 36months following randomization of 284 outpatients to one of four motivational interviewing and cognitive–behavior therapy (MICBT) based interventions: (1) brief integrated intervention (BI); or BI plus 9 further sessions with (2) an integrated-, (3) alcohol-, or (4) depression-focus. Outcome measures included changes in alcohol consumption, depression (BDI-II: Beck Depression Inventory) and functioning (GAF: Global Assessment of Functioning), with average improvements from baseline of 21.8 drinks per week, 12.6 BDI-II units and 8.2 GAF units. Longer interventions tended to be more effective in reducing depression and improving functioning in the long-term, and in improving alcohol consumption in the short-term. Integrated treatment was at least as good as single-focused MICBT. Alcohol-focused treatment was as effective as depression-focused treatment at reducing depression and more effective in reducing alcohol misuse. The best approach seems to be an initial focus on both conditions followed by additional integrated- or alcohol-focused sessions. [Copyright &y& Elsevier]

Background Generalized Anxiety Disorder (GAD), characterized by excessive and uncontrollable worry, has a negative impact on the health, well-being, and functioning of older adults. Cognitive behavioral therapy has demonstrated efficacy in reducing anxiety and worry in older adults, but the generalizability of these findings to community-dwelling older adults is unknown. The aim of the current study is to examine the efficacy of a cognitive-behavioral intervention delivered by telephone in reducing anxiety and worry in rural community-dwelling older adults with GAD. Methods/design We propose a randomized controlled trial comparing telephone-delivered cognitive behavioral therapy (CBT-T) with nondirective supportive therapy (NST-T). One hundred seventy six adults 60 years and older diagnosed with GAD will be randomized to one of the two treatment conditions. The primary outcomes are self-report worry and clinician-rated anxiety. Secondary outcomes include depressive symptoms, sleep, quality of life, and functional status. Discussion It is hypothesized that CBT-T will be superior to NST-T in reducing anxiety and worry among older adults with GAD. Further, CBT-T is hypothesized to be superior to NST-T in reducing problems with depressive symptoms, sleep, functional status and quality of life. If this program is successful, it could be implemented as a low-cost program to treat late-life anxiety, especially in rural areas or in circumstances where older adults may not have access to qualified mental health providers. Trial registration clinicaltrials.gov Identifier: NCT01259596 [ABSTRACT FROM AUTHOR]

Objective: In this randomized controlled trial, we investigated the effectiveness of a school-based targeted intervention program for disruptive behavior. A child-focused cognitive behavioral therapy (CBT) program was introduced at schools in disadvantaged settings and with active teacher support (ATS) versus educational teacher support (ETS) (CBT + ATS vs. CBT + ETS). Method: Screening (n = 1,929) and assessment (n = 224) led to the inclusion of 173 children ages 8-12 years from 17 elementary schools. Most of the children were boys (n = 136, 79%) of low or low-to-middle class socioeconomic status (87%); the sample was ethnically diverse (63% of non-Western origin). Children received CBT + ATS (n = 29) or CBT + ETS (n = 41) or were entered into a waitlist control condition (n = 103) to be treated afterward (CBT + ATS, n = 39, and CBT + ETS, n = 64). Effect sizes (ES), clinical significance (reliable change), and the results of multilevel modeling are reported. Results: Ninety-seven percent of children completed treatment. Teachers and parents reported positive posttreatment effects (mean ES = .31) for CBT compared with the waitlist control condition on disruptive behavior. Multilevel modeling showed similar results. Clinical significance was modest. Changes had remained stable or had increased at 3-months follow-up (mean ES = .39). No consistent effect of teacher condition was found at posttreatment; however, at follow-up, children who received ETS fared significantly better. Conclusions: This study shows that a school-based CBT program is beneficial for difficult-to-reach children with disruptive behavior: The completion rate was remarkably high, ESs (mean ES = .31) matched those of previous studies with targeted intervention, and effects were maintained or had increased at follow-up. [ABSTRACT FROM AUTHOR]

Objective: Our aim in this randomized controlled trial was to investigate the effects on global tinnitus severity of 2 Internet-delivered psychological treatments, acceptance and commitment therapy (ACT) and cognitive behavior therapy (CBT), in guided self-help format. Method: Ninety-nine participants (mean age = 48.5 years; 43% female) who were significantly distressed by tinnitus were recruited from the community. Participants were randomly assigned to CBT (n = 32), ACT (n = 35), or a control condition (monitored Internet discussion forum; n = 32), and they were assessed with standardized self-report measures (Tinnitus Handicap Inventory; Hospital Anxiety and Depression Scale; Quality of Life Inventory; Perceived Stress Scale; Tinnitus Acceptance Questionnaire) at pre-, posttreatment (8 weeks), and 1-year follow-up. Results: Mixed-effects linear regression analysis of all randomized participants showed significant effects on the primary outcome (Tinnitus Handicap Inventory) for CBT and for ACT compared with control at posttreatment (95% CI [- 17.03, -2.94], d = 0.70, and 95% CI [-16.29, -2.53], d = 0.68, respectively). Within-group effects were substantial from pretreatment through 1-year-follow-up for both treatments (95% CI [-44.65, -20.45], d = 1.34), with no significant difference between treatments (95% CI [-14.87, 11.21], d = 0.16). Conclusions: Acceptance-based procedures may be a viable alternative to traditional CBT techniques in the management of tinnitus. The Internet can improve access to psychological interventions for tinnitus. [ABSTRACT FROM AUTHOR]