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Objective: This study aimed to investigate whether attentional control serves as a mediator for mindfulness‐based interventions for emotional distress, utilizing a randomized waitlist (WL)‐controlled design. Methods: A total of 498 participants with high emotional distress was recruited online and randomly assigned to a 49‐day online Mindfulness Intervention for Emotional Distress (MIED) group (N = 249) or a WL control group (N = 249). Levels of attentional control, anxiety and depression were assessed at baseline (T0), Week 3 (T3), Week 5 (T5) and Week 7 (postintervention, T7). Results: Linear mixed models revealed significant Group‐by‐Time interaction effects for attentional control (p < 0.001), anxiety (p < 0.001) and depression (p < 0.05). Latent growth curve analyses demonstrated a significant increase in attentional control and a decrease in anxiety and depression levels during the MIED programme. These changes becoming evident starting Week 3. Longitudinal mediation analyses revealed that the slope of attentional control significantly mediated the effects of the MIED programme on the slope of anxiety and depression levels. Further, attentional control level at Week 3 significantly mediates the effect of MIED programme on anxiety and depression levels at Weeks 5 and 7. Similarly, attentional control level at Week 5 significantly mediates the MIED programme's effects on anxiety and depression levels at Week 7. Conclusions: The present trial provides evidence suggesting that mindfulness interventions may alleviate emotional distress through the enhancement of attentional control. Trial Registration: Chinese Clinical Trial Registry number: ChiCTR2200064140 [ABSTRACT FROM AUTHOR]

Background: There are many barriers to engaging in current psychological treatments, including time, cost, and availability. Ultra-brief treatments overcome some of these barriers by delivering therapeutic information and skills using significantly less time than standard-length treatments. We developed a therapist-guided online ultra-brief treatment for depression and anxiety and compared it to an existing 8-week, 5-lesson therapist-guided standard-length treatment and a waitlist control. Methods: In a randomized controlled trial, adults with self-reported depression or anxiety were randomized (1:1:1) to the ultra-brief treatment, standard-length treatment, or waitlist control. The primary outcomes were depression symptoms and anxiety symptoms assessed at baseline, 5-weeks later, 9-weeks later (primary timepoint), and 3-months later. The trial was prospectively registered. Results: Between 7 February 2022, and 16 August 2022, 242 participants were enrolled in the ultra-brief treatment (n = 85), standard-length treatment (n = 80), and waitlist control (n = 77). Participants were mostly women with an average age of 48.56 years. At 9-weeks post-baseline, participants in the ultra-brief treatment group reported significantly lower depression (between groups d = 0.41) and anxiety (d = 0.53) than the waitlist control. The ultra-brief treatment was non-inferior for anxiety at both 9-weeks and 3-months follow-up. Non-inferiority for depression was observed at 9-weeks. Conclusions: The online ultra-brief treatment resulted in significant reductions in depression and anxiety that were non-inferior to a longer treatment course after 9-weeks. Remotely delivered ultra-brief treatments have the potential to provide accessible and effective care for those who cannot, or would prefer not to, access longer psychological interventions. [ABSTRACT FROM AUTHOR]

Healthcare professionals were especially vulnerable to pandemic, both to become infected and to develop a psychological problem. The aim of this systematic review is to analyze the effectiveness of psychological interventions for healthcare professionals in reducing the experienced psychological impact. From the 405 identified studies, 10 were included in this review. Four databases were searched and the risk of bias of included studies was assessed. The studies considered were randomized controlled trials. The screening and selection process was conducted by two independent reviewers. All studies presented results related with depression, anxiety, and stress during pandemic. Six were delivered using new technologies. The most effective were two psychological interventions with frequent contact and feedback provided by a mental health professional. The psychological interventions compared with non‐intervention groups presented more significant results than those compared with another intervention. The highlights of this systematic review were the urgency of designing effectiveness psychological interventions for healthcare professionals to reduce the emotional burden associate with this job. These interventions should be maintained over the time, supported by a professional and provided from the workplace. These proposals presented promising results but were more psychological resources than psychological interventions. [ABSTRACT FROM AUTHOR]

To synthesize results of six controlled trials of self-care interventions for depression and/or anxiety, focusing on five trials in which lay guidance was compared to self-directed use of the same self-care tools. The trials were conducted in Canada in different target populations. Self-care tools were adapted to each population. Guidance was provided in 3–15 calls over a period of 6–26 weeks. Depression and/or anxiety were assessed at follow-up (6–26 weeks). Pooled analyses used a meta-analytic approach. Engagement with the self-care tools was compared using the standardized difference or Cohen's d effect size. In studies with homogeneous outcomes (three for depression, four for anxiety), the pooled effect sizes of guidance vs. self-directed use of the self-care tools were 0.36 (95% CI 0.10, 0.62, N = 235) for depression and 0.21 (95% CI -0.03, 0.44, N = 285) for anxiety. Guidance consistently led to greater engagement with the tools. The intervention model is a potentially sustainable and accessible alternative to professionally guided self-care for people with mild-moderate depression. Factors which may have limited implementation success include: co-interventions, reduced number of guide calls (3 vs 6 or more), and delivery to dyads (patient-caregiver). [ABSTRACT FROM AUTHOR]

Background: Exposure-based therapy is the treatment of choice for anxiety disorders, but many patients do not benefit sufficiently from it. Distressing images of threat related to the future or past may maintain the anxiety symptomatology or impede exposure therapy. An intervention that targets threat-related imagery is eye movement desensitization and reprocessing (EMDR) therapy. The main goal of this multicenter randomized controlled trial is to investigate whether EMDR therapy plus exposure therapy, relative to supportive counseling plus exposure therapy, improves treatment efficacy, tolerability, and adherence in patients with panic disorder. In addition, we will examine potential predictors of optimal treatment allocation, mechanisms of change as well as the long term effects of treatment. Finally, we will assess cost-effectiveness. Methods: A multicenter randomized controlled trial mixed design will be conducted. Participants will be 50 patients, aged ≥ 18, diagnosed with a panic disorder. They will be randomly assigned to one of two conditions: EMDR therapy (i.e., flashforward strategy) or supportive counseling (each consisting of four weekly sessions of 90 min each) prior to exposure therapy (consisting of eight weekly sessions of 90 min each). Assessments will be made pre-treatment (T1), between-treatments (T2), post-treatment (T3), one month post-treatment (FU1) and six months post-treatment (FU2) by an assessor blind to treatment condition. The primary outcome measure is severity of panic-related symptoms. Secondary outcome measures are: tolerability of exposure therapy (initial avoidance, willingness to start exposure therapy, considered drop-out; no-show and drop-out), related symptomatology (generalized anxiety, depression), and functional impairment. Discussion: The primary goals of this research are to compare the efficacy, tolerability, and adherence of EMDR therapy plus exposure therapy and supportive counseling plus exposure therapy and to identify predictors, moderators, and mediators for treatment success. This multi-center research aims to make a significant contribution to our understanding as to how treatment for patients with anxiety disorders can be optimized, and elucidate who can benefit most from this novel approach. Trial registration: ISRCTN—ISRCTN29668369: Improving anxiety treatment by modifying emotional memories before real-life exposure. Registered 27 June 2022—retrospectively registered. ISRCTN—ISRCTN29668369. [ABSTRACT FROM AUTHOR]

Background: Auriculotherapy may activate the parasympathetic nerve system and reduce anxiety levels. Short-term auriculotherapy's effects and safety on university students' anxiety levels was assessed prior to exams. Methods: A randomized, controlled pilot trial was conducted. The day before the exam, university students were randomly allocated to the auriculotherapy group (AA, n = 13) or the waiting-list group (WG, n = 13). Baseline measures were taken 4 weeks before the exam at Time point (TP 0); at 7.30 a.m. on the day before the exam (TP I); at 11 a.m. before auriculotherapy (TP II); 30 min after AA (TP III); and at 7.30 a.m. before the exam (TP IV). The outcomes were the State-Trait-Anxiety Inventory (STAI); quality of night-sleep, Visual Analogue scale (VAS) for anxiety, and salivary cortisol. Adverse events were also recorded. Results: A total of 26 students participated in this study and became more anxious as assessed by STAI in TPII (p = 0.002) and TPIV (p = 0.000) than TP0. AA reduced the STAI in TPIII (p = 0.045) and PIV (p = 0.001) and the VAS (p = 0.012) in TPIV. Cortisol was reduced in TPIII (p = 0.004), and the AA slept better (p = 0.014) at TPIV. Discomfort at the auricular site was reported in only one AA participant. Conclusions: Auriculotherapy appeared safe and effective in reducing anxiety levels before university exams. [ABSTRACT FROM AUTHOR]

Background: Gynecological malignant patients often have significant psychological and physical problems. The feasibility and generalizability of traditional intervention method is low due to the high time and labor cost, large number of gynecological malignant tumor patients in China, as well as shortage of health professionals. Therefore, it is necessary to design an alternative, innovative, and easily accessible intervention method. This study aims to evaluate the effect of WeChat-based intervention on anxiety, depression and disease-related symptoms of patients with gynecological malignant tumors during rehabilitation.Methods: A single-blinded, randomized, controlled, parallel-group pre-test and repeated post-test design will be conducted. A total of 76 participants will be randomly divided into the intervention group and control group. Anxiety and depression, disease-related symptoms, coping ability, benefit finding and quality of life will be measured at baseline and repeated immediately after the intervention (test 1), 3 months (test 2) and 6 months (test 3) after the intervention.Discussion: As the first randomized controlled trial with rigorous research design for patients with gynecological malignant tumors in the rehabilitation stage in China, this study will provide evidences for the effectiveness of the WeChat platform during intervention of patients with gynecological malignant tumors in the rehabilitation stage. The results are helpful to further explore the effect of WeChat-based intervention on improving patients' anxiety and depression, disease-related symptoms, and quality of life.Trial Registration: Chinese Clinical Trial Registry: ChiCTR2100053450, Registered 21 November 2021, http://www.chictr.org.cn/searchproj.aspx. [ABSTRACT FROM AUTHOR]

Background: Lifestyle medicine (LM) is gaining increasing attention as a treatment option for anxiety, but the current state of evidence has not yet been systematically examined.Methods: Six electronic databases were systematically searched from inception to February 2022. Randomized controlled trials (RCTs) comparing the effects of multicomponent LM interventions on anxiety symptoms with either care-as-usual, waitlist, no intervention, or attention control group on anxiety symptoms were identified.Results: A total of 53 RCTs with 18,894 participants were included for qualitative synthesis, in which 45 RCTs with data available were included for meta-analysis. Multicomponent LM intervention was significantly more effective than the control groups in reducing anxiety symptoms at immediate posttreatment (d = 0.19, p < .001) and at short-term follow-up (d = 0.29, p < .001). However, no significant difference at medium-term was found (p = .14), whereas more studies are needed to study the long-term effects. The subgroup analyses suggested that baseline anxiety symptoms was a significant moderator, suggesting that those with moderate level of baseline anxiety symptoms appeared to have greater improvements (d = 0.66, p < .05).Limitations: Minimal anxiety symptoms at baseline contributed to the floor effect and influenced the degree of improvement. The included RCTs had a high risk of bias in general with potential publication bias detected.Conclusion: The findings of this meta-analysis provided support for the positive effects of multicomponent LM interventions for anxiety symptoms. Future research is needed to determine the long-term effects of multicimponent LM and the optimal baseline anxiety severity. [ABSTRACT FROM AUTHOR]

Survivors of domestic and family violence (DFV) report poorer quality of life and worsening mental health. This study evaluated the effect of a counseling and education intervention on the mental health and help-seeking behaviors among pregnant women living with DFV. A parallel pilot randomized controlled trial was performed among 140 pregnant women attending an antenatal clinic of a tertiary hospital of Nepal. Using computer-generated random numbers, participants were randomized to the intervention group (a counseling session, an information booklet about DFV, and contact details of the counselor) or a control group (usual care plus a booklet containing contact details of local DFV support services). Outcome measures included mental health, quality of life (QOL), self-efficacy, social support, and safety planning behaviors. Analyses followed intention-to-treat, using the generalized estimating equation model. Intervention participants showed significant improvements in anxiety (β = −3.24, p <.001) and depression (β = −3.16, p <.001) at postintervention. Such improvements were also sustained at follow-up assessment (p <.001). Significant group and time interaction for QOL, social support, use of safety behaviors, and self-efficacy (p <.05) revealed a greater increase in these outcome measures among intervention participants at both follow-up assessments compared with the control group. This pilot integrated intervention showed promising outcomes in improving the mental health, social support, and the use of safety behaviors among women with DFV. This intervention could be incorporated into regular antenatal care as a strategy to identify and support victims of DFV. Larger controlled trials with longer follow-up are needed to support and expand on the current findings regarding the effectiveness of a psychosocial intervention targeting victims of DFV in resource-constrained settings. [ABSTRACT FROM AUTHOR]

Objective: To compare the clinical effects of interactive dynamic scalp acupuncture (IDSA), simple combination therapy (SCT), and traditional scalp acupuncture (TSA) on cognitive function, depression and anxiety in patients with post-stroke cognitive impairment. Methods: A total of 660 patients with post-stroke cognitive impairment who were admitted to 3 hospitals in Shenzhen City between May 2017 and May 2020 were recruited and randomly assigned to the IDSA (218 cases), SCT (222 cases) and TSA groups (220 cases) according to a random number table. All the patients received conventional drug therapy for cerebral stroke and exercise rehabilitation training. Scalp acupuncture and computer-based cognitive training (CBCT) were performed simultaneously in the IDSA group, but separately in the morning and in the afternoon in the SCT group. The patients in the TSA group underwent scalp acupuncture only. The course of treatment was 8 weeks. Before treatment (M0), 1 (M1) and 2 months (M2) after treatment, as well as follow-up at 1 (M3) and 2 months (M4), the cognitive function of patients was assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment Scale (MoCA) Scales; depression, anxiety, sleep quality, and self-care ability of patients were assessed using Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), and Modified Barthel Index (MBI), respectively. During this trial, all adverse events (AEs) were accurately recorded. Results: There were no significant differences in the MMSE, MoCA, HAMD, HAMA, PSQI, and MBI scores among the 3 groups at M0 (all P>0.05). In the IDSA group, the MMSE, MoCA and MBI scores from M2 to M4 were significantly higher than those in the SCT and TSA groups, while the HAMD, HAMA and PSQI scores were significantly reduced (all P<0.01). The changes of all above scores (M2-M0, M4-M0) were significantly superior to those in the SCT and TSA groups (all P<0.01, except M4-M0 of HAMD). At M2, the severity of MMSE, HAMD, HAMA, PSQI and MBI in the IDSA group was significantly lower than that in the SCT and TSA groups (all P<0.01). There was no serious AE during this trial. Conclusions: IDSA can not only significantly improve cognitive function, but also reduce depression, anxiety, which finally improves the patient's self-care ability. The effect of IDSA was significantly better than SCT and TSA. (Trial registration No. ChiCTR1900027206) [ABSTRACT FROM AUTHOR]

Background: There is a need for high-quality research regarding exercise interventions for persons with anxiety disorders. We investigate whether a 12-week exercise intervention, with different intensities, could reduce anxiety symptoms in patients with anxiety disorders.Methods: 286 patients were recruited from primary care in Sweden. Severity of symptoms was self-assessed using the Beck Anxiety Inventory (BAI) and the Montgomery Åsberg Depression Rating Scale (MADRS-S). Participants were randomly assigned to one of two group exercise programs with cardiorespiratory and resistance training and one control/standard treatment non-exercise group, with 1:1:1 allocation.Results: Patients in both exercise groups showed larger improvements in both anxiety and depressive symptoms compared to the control group. No differences in effect sizes were found between the two groups. To study a clinically relevant improvement, BAI and MADRS-S were dichotomized with the mean change in the control group as reference. In adjusted models the odds ratio for improved symptoms of anxiety after low-intensity training was 3.62 (CI 1.34-9.76) and after moderate/high intensity 4.88 (CI 1.66-14.39), for depressive symptoms 4.96 (CI 1.81-13.6) and 4.36 (CI 1.57-12.08) respectively. There was a significant intensity trend for improvement in anxiety symptoms.Limitations: The use of self-rating measures which bears the risk of an under- or overestimation of symptoms.Conclusions: A 12-week group exercise program proved effective for patients with anxiety syndromes in primary care. These findings strengthen the view of physical exercise as an effective treatment and could be more frequently made available in clinical practice for persons with anxiety issues. [ABSTRACT FROM AUTHOR]

Background: Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT). Methods: A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0–100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434. Results: A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8–27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38–1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8–6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00–4.70, p = 0.050). Adverse events were few and insignificant. Conclusions: iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness‐based approaches on the mental health of healthcare workers at the frontline against COVID‐19 in Spain. Design: We will carry out a two‐week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention. Methods: The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID‐19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS‐21 questionnaire—primary endpoint), insomnia (ISI), burnout (MBI‐HSS), post‐traumatic stress disorder (DTS), and self‐efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation. Discussion: Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context. Impact: Despite the lack of solid evidence about their effectiveness, mobile‐based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits. Clinical trial registration: NCT04393818 (ClinicalTrials.gov identifier). Approved funding: May 2020. [ABSTRACT FROM AUTHOR]

• Examined an inhibitory learning (IL) approach to exposure in youth using a randomized design. • Data supported the acceptability and feasibility of an IL approach to exposure. • Case examples contrast an IL approach to exposure versus a standard approach to exposure. • Discussion of lessons learned in implementing an IL approach to exposure in youth. Accumulating evidence from basic and translational research indicates that fear extinction may be best explained by principles of "inhibitory learning," by which prefrontal cortical structures inhibit activity in the amygdala. New guidelines for the clinical practice of exposure therapy have arisen from research on inhibitory learning, but these guidelines have received little empirical testing in clinical samples of youth receiving treatment for anxiety disorders. We investigated the acceptability, feasibility, and initial efficacy of conducting exposure therapy for anxiety disorders in youth according to clinical guidelines developed from basic research on inhibitory learning principles, using a pilot randomized controlled trial design. Thirteen youths (ages 7 to 16) were recruited from a university hospital-based pediatric outpatient clinic to participate in a 9-week treatment study and were randomized to either an inhibitory learning-based exposure condition or a standard exposure condition. Results supported the feasibility and acceptability of an inhibitory learning-based approach to exposure therapy in youth and, despite the small sample size, effect sizes were in favor of the inhibitory learning approach on several measures. Differences between the standard exposure and inhibitory learning conditions are discussed using two case examples. Discussion of results and lessons learned may contribute to changes in clinical guidelines for optimally effective practice of exposure. [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]

Background: Generalized anxiety disorder (GAD) is a highly prevalent, chronic disorder associated with impaired quality of life, societal burden, and poor treatment rates. Internet‐delivered interventions may improve the accessibility of treatments and are increasingly being used. This study aimed to update a previous meta‐analysis to determine the effectiveness of available Internet‐delivered interventions in treating symptoms of GAD. Method: Systematic literature searches were conducted (through April 2020) using Embase, PubMed, PsychINFO, and Cochrane to find randomized controlled trials of Internet‐delivered interventions for GAD. Risk of bias was evaluated, and Hedge's g was calculated at posttreatment and follow‐up. Results: Twenty studies met eligibility criteria and were included in the meta‐analysis. Random‐effect models detected large effect sizes for primary outcomes of anxiety (g = 0.79) and worry (g = 0.75), favoring treatment. Effect sizes for depression, functional impairment, and quality of life were moderate to large. Maintenance of effects at follow‐up seems likely. Conclusions: Results support the effectiveness of Internet‐delivered treatments for GAD. Considerable heterogeneity between studies appeared moderated by variability in the interventions themselves, highlighting the importance of further investigation into the characteristics that may optimize treatment outcomes. Overall, Internet‐delivery appears to be a viable mode of treatment for GAD with potential to relieve existing gaps in the provision of treatment. [ABSTRACT FROM AUTHOR]

Objective: Cost, distance, and stigma may present barriers to face-to-face treatment for anxiety disorders. Technology can help overcome these barriers. The evidence map presented here provides an overview of technology use in clinical care for anxiety.Methods: Searches in three databases from their inception dates to June 2019 identified published randomized controlled trials (RCTs) examining technology use in anxiety disorder management. Reviewers screened 4,061 records, included 128 RCTs, and extracted data on study characteristics and technology type, function, and effectiveness.Results: In 88% of the 128 RCTs, the authors reported reduced anxiety symptoms postintervention. Studies of computer technology (66%) and patient self-directed psychotherapy (31%) were most common. Many interventions were studied by only a few RCTs, and many studies had small sample sizes.Conclusions: Almost all interventions reported improved anxiety symptoms, with computer applications having the largest evidence base. More information is needed to evaluate the role of technology in clinical care for anxiety. [ABSTRACT FROM AUTHOR]

BACKGROUND: Tuina for knee osteoarthritis has obvious curative effect, and has been widely used in clinical practice due to its characteristics, including simple operation, popularization, and good comfort. OBJECTIVE: To observe the clinical effect of the combination of pressing points of local acupoint plus adjustion of the knee joint in a sitting position in the treatment of knee osteoarthritis under “emphasizing both bones and tendons” as the guiding ideology of Tuina. METHODS: Ninety-one patients with knee osteoarthritis were randomly divided into a treatment group (n=46) and a control group (n=45). The treatment group was given the pressing points of local acupoint plus adjustion of the knee joint in a sitting position, and the control group was treated with oral celecoxib for 4 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the pressure pain thresholds, the Visual Analogue Scale scores at rest and at movement, and Hospital Anxiety and Depression Scale score were analyzed before and after treatment. The total clinical efficacy and adverse reaction index score were observed. The study was approved by the Ethics Committee of Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine on June 5, 2017, approval number: 2017-k-11. All participants were informed of the trial protocol and process, and signed informed consent. This study was registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/searchproj.aspx, ChiCTR1900022928) on May 4, 2019. RESULTS AND CONCLUSION: After 4 weeks of treatment: (1) The scores of WOMAC in both groups were improved compared with the baseline, and those in the treatment group decreased more significantly (P < 0.05); (2) the pressure pain thresholds of two groups were significantly improved compared with the baseline, and the treatment group was better than the control group (P < 0.05); (3) the Visual Analogue Scale scores at rest and at movement in the treatment group were decreased significantly compared with those in the control group (P < 0.05); (4) the scores of Hospital Anxiety and Depression Scale in terms of depression and anxiety in the treatment group were significantly lower than those in the control group (P < 0.05); (5) the total effective rate of the treatment group was 93.18%, and the control group was 81.40%, with significant difference between the two groups (P < 0.05); (6) there was no significant difference in the adverse reaction scores between the two groups (P > 0.05). Overall, the above results indicate that with “emphasizing both bones and tendons” as the guiding ideology of Tuina, the clinical effect of the pressing points of local acupoint and adjustion of the knee joint in a sitting position in the treatment of knee osteoarthritis is better than that of oral celecoxib. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to investigate the effect of Diaphragmatic breathing exercise on pain, anxiety, and depression in patients undergoing total knee replacement. Material and Methods: It is a randomized controlled trial. The study population consisted of patients who underwent total knee replacement surgery in the orthopedic ward of Çankırı State Hospital between May and August 2019. The study sample included a total of 38 patients satisfying the inclusion criteria. Stratified randomization was used to assign the patients into sex-matched intervention group (n=19) and control group (n=19). Patients in the intervention group were also trained in the Diaphragmatic breathing exercise procedure. Descriptive characteristics form, visual analogue scale and hospital anxiety and depression scale were used to collect data. Pain scores were evaluated at 1, 2, 4, 8, 12, and 24 hours postoperatively, while the anxiety and depression was applied on the postoperative day 2. Data were analyzed using descriptive statistics, Chi-square test, and Mann–Whitney U test. Results: Mean age was 65.26±6.73 years in the intervention group and 68.78±5.88 years in the control group. There were also no significant differences in Visuel Analog Scale pain scores (P>.05). Mean score anxiety was significantly lower in the intervention group compared to the control group (P=.033). However, the difference in the depression was not significant (P>.05). Conclusion: The results of our study demonstrated that Diaphragmatic breathing exercise had no effect on pain and depression but reduced anxiety after total knee replacement surgery. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depressive disorders are often characterized by perceived social disconnection, yet evidence-based treatments produce only modest improvements in this domain. The well-established link between positive affect (PA) and social connectedness suggests that directly targeting PA in treatment may be valuable. Method: A secondary analysis of a waitlist-controlled trial (N = 29) was conducted to evaluate treatment response and process of change in social connectedness within a 10-session positive activity intervention protocol—Amplification of Positivity (AMP)—designed to increase PA in individuals seeking treatment for anxiety or depression (ClinicalTrials.gov Identifier: NCT02330627). Perceived social connectedness and PA/negative affect (NA) were assessed throughout treatment. Time-lagged multilevel mediation models examined the process of change in affect and connectedness throughout treatment. Results: The AMP group displayed significantly larger improvements in social connectedness from pre- to post-treatment compared to waitlist; improvements were maintained through 6-month follow-up. Within the AMP group, increases in PA and decreases in NA both uniquely predicted subsequent increases in connectedness throughout treatment. However, experiencing heightened NA throughout treatment attenuated the effect of changes in PA on connectedness. Improvements in connectedness predicted subsequent increases in PA, but not changes in NA. Conclusions: These preliminary findings suggest that positive activity interventions may be valuable for enhancing social connectedness in individuals with clinically impairing anxiety or depression, possibly through both increasing positive emotions and decreasing negative emotions. [ABSTRACT FROM AUTHOR]

Background: Anxiety is a common symptom in patients with the Acute Coronary Syndrome (ACS), which can threaten their quality of life. This study was done to compare the effects of aromatherapy using lavender and Benson's relaxation technique on the anxiety of patients with ACS. Methods: In this randomized clinical trial, 96 patients with ACS were selected using consecutive sampling method from two hospitals in an urban area of Iran. The patients were randomly assigned to three groups of aromatherapy (n=32), Benson's relaxation (n=32), and control (n=32) using the block size of six. The interventions were performed on two consecutive days, once a day for 20 min. Anxiety was measured before and immediately after the intervention using the Spielberger's Anxiety Inventory. Data were analyzed using the Chi-square test, Fisher's exact test, one-way Analysis Of Variance (ANOVA), Bonferroni post hoc test, and mixed-model repeated-measures ANOVA with a 3*2*2 design by the SPSS V. 16. Results: There was no statistically significant difference in state and trait anxiety scores between the groups after the intervention on different time points (P> 0.05). The time (P=0.001), group-day interaction (P=0.005), and time (pretest and posttest) and day (P=0.029) effect on state anxiety was statistically significant. The time (P<0.001) and the group-day interaction (P<0.001) effect on trait anxiety was statistically significant. Conclusion: Benson's relaxation method and lavender aromatherapy did not significantly reduce anxiety in patients with ACS. Considering the anxiety and its complications in patients with ACS and the importance of its management, further studies are needed to determine appropriate care and treatment for these patients and reduce their anxiety. [ABSTRACT FROM AUTHOR]

Background: We have demonstrated the efficacy of a brief behavioral intervention for sleep in children with ADHD in a previous randomized controlled trial and now aim to examine whether this intervention is effective and cost‐effective when delivered by pediatricians or psychologists in community settings. Methods: Translational, cluster‐randomized trial of a behavioral intervention versus usual care from 19th January, 2015 to 30th June, 2017. Participants (n = 361) were children aged 5–13 years with ADHD and parent report of a moderate/severe sleep problem who met criteria for American Academy of Sleep Medicine criteria for chronic insomnia disorder, delayed sleep–wake phase disorder, or were experiencing sleep‐related anxiety. Participants were randomized at the level of the pediatrician (n = 61) to intervention (n = 183) or usual care (n = 178). Families in the intervention group received two consultations with a pediatrician or a psychologist covering sleep hygiene and tailored behavioral strategies. Results: In an intention‐to‐treat analysis, at 3 and 6 months respectively, the proportion of children with moderate to severe sleep problems was lower in the intervention (28.0%, 35.8%) compared with usual care group (55.4%, 60.1%; 3 month: risk ratio (RR): 0.51, 95% CI 0.37, 0.70, p < .001; 6 month: RR: 0.58; 95% CI 0.45, 0.76, p < .001). Intervention children had improvements across multiple Children's Sleep Habits Questionnaire subscales at 3 and 6 months. No benefits of the intervention were observed in other domains. Cost‐effectiveness of the intervention was AUD 13 per percentage point reduction in child sleep problem at 3 months. Conclusions: A low‐cost brief behavioral sleep intervention is effective in improving sleep problems when delivered by community clinicians. Greater sample comorbidity, lower intervention dose or insufficient clinician supervisions may have contributed to the lack benefits seen in our previous trial. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depressive disorders are common mental disorders. A substantial part of patients does not achieve symptomatic remission after treatment in specialized services. Current care as usual (CAU) for these patients consists of long-term supportive contacts. Termination of CAU is often not considered to be an option due to persistent symptoms, a low level of functioning, and the absence of further treatment options. A new intervention, ZemCAD, offers a program focused on rehabilitation and self-management, followed by referral back to primary care. Methods: This multicenter randomized controlled trial was carried out in twelve specialized outpatient mental health care services in the Netherlands. Consenting and eligible patients were invited for the MINI interview and the baseline questionnaire. Assessments were done at 6 (T1), 12 (T2) and 18 (T3) months post baseline. We used linear mixed model analysis (LMM) to ascertain the effectiveness of the ZemCAD group relative to the CAU group on quality of life, symptom severity and empowerment. Results: In total 141 patients were included. The results at 18-month follow-up regarding to quality of life and symptom severity, showed no significant differences between the ZemCAD group and the CAU group, except on the 'social relationships'-domain (d = 0.37). With regard to empowerment a significant difference between both groups was observed in the total empowerment score and one empowerment dimension (d = 0.45 and d = 0.39, respectively). After the ZemCAD intervention, more patients went from specialized outpatient mental health services back to a less specialized health care setting with less intensive treatment, such as primary care. Conclusion: The findings in this study suggest that patients with chronic and treatment-resistant anxiety and depression using the ZemCAD intervention improve on empowerment but not on symptom severity or quality of life. Since little is known about the effects of rehabilitation and self-management in patients with chronic and treatment resistant anxiety and depressive disorders, this is a first attempt to provide a proof-of-concept study in this under-researched but important field. Trial registration: Netherlands Trial Register: NTR3335, registered 7 March 2012. [ABSTRACT FROM AUTHOR]

Objective To evaluate the effectiveness of hand massage on the pain and anxiety of the cardiac surgery critically ill. Design A three-arm randomized controlled trial. Setting This study was conducted in a medical-surgical intensive care unit in Canada. Subjects Adult patients who underwent elective cardiac surgery, who were able to speak French/English and to self-report symptoms, without a high risk of postoperative complications were eligible. Methods Patients were randomly allocated to standard care plus either two 20-minute hand massages (experimental), two 20-minute hand holdings (active control), or two 20-minute rest periods (passive control/standard care). Pain intensity, pain unpleasantness, anxiety, muscle tension, and vital signs were evaluated before, after, and 30 minutes later for each intervention. Results From the 83 patients recruited, 60 were randomized (20 massage, 19 hand holding, 21 standard care). After controlling for baseline scores, the massage group reported significantly lower pain intensity, pain unpleasantness, and anxiety for the first data collection set compared with both hand holding and standard care (analysis of covariance, P  < 0.02), with an average decrease of two points on a 0–10 scale. No statistically significant differences were noted between hand holding and standard care for any of the symptoms. Similar results were observed for the second data collection set (N = 43). Patients had decreased muscle tension post massage. Vital signs did not differ significantly between groups. Conclusions Findings suggest that a 20-minute hand massage in addition to routine postoperative pain management can concomitantly reduce pain intensity, pain unpleasantness, and anxiety by two points on average on a 0–10 scale. [ABSTRACT FROM AUTHOR]

Highlights • CBT yielded greater symptom reduction than ABM when both were given standard doses. • However, rates of change were similar for both interventions on almost all measures. • Symptom change in CBT showed a reciprocal relationship with cognitive change. • Symptoms and attention away from threat were possibly related simultaneously in ABM. Abstract No studies have compared face-to-face cognitive-behavioral therapy (CBT) and attention bias modification (ABM) for social anxiety disorder (SAD) and their purported mechanisms. We asked: 1) Is CBT more effective than ABM? and 2) Are changes in attentional biases and cognitions temporally related to symptom change? Forty-three patients were randomly assigned to 8 sessions of ABM or up to 20 sessions of individual CBT. Intent-to-treat results revealed that CBT was superior to ABM in response rates and on symptom measures at endpoint, but not on other measures. No differences were found on measures in rates of change between CBT and ABM. Frequency of negative cognitions changed in both groups and negative beliefs changed only in CBT. Attentional bias did not change in either group. Cognitive changes bidirectionally correlated with symptom change in cross-lagged analyses in CBT, but not in ABM, suggesting a reciprocal relationship. Trial-level bias away from negative faces was simultaneously related to symptom change in ABM only. Results suggest that CBT is superior to ABM when administered at their typical doses, but raise questions given the similar rates of change. In addition, results support theories of cognitive change and raise questions about changes in attentional biases in CBT. [ABSTRACT FROM AUTHOR]

Background: The management of suicidal crisis remains a major issue for clinicians, driving the development of new strategies to improve suicide prevention.Methods: We conducted a randomized controlled trial comparing a 7-week acceptance and commitment therapy (ACT) versus relaxation group, as adjunct to treatment as usual for adult outpatients suffering from a current suicidal behavior disorder. The primary outcome was the rate of change in the Columbia Suicide Severity Rating Scale suicidal ideation subscore (adding severity and intensity subscores). Secondary outcomes were the rates of change for depressive symptomatology, psychological pain, anxiety, hopelessness, anger, quality of life, and therapeutic processes. Assessments were performed in the 2 weeks preceding the beginning of the treatment (pretreatment assessment), and within 1 week (posttherapy assessment) and 3 months (follow-up assessment) after therapy completion.Results: Forty adults were included and randomized. The rate of change in ACT for suicidal ideation at the posttherapy assessment was higher than in the relaxation group (β [SE] = -1.88 [0.34] vs. -0.79 [0.37], respectively; p = 0.03). ACT effectiveness remained stable at the 3-month follow-up. We found a similar pattern of change for depressive symptomatology and anxiety, psychological pain, hopelessness, anger, and quality of life. Therapeutic processes improved more in the ACT group than in the relaxation group. Treatment adherence was high in the ACT group, all participants reported satisfaction with the program.Conclusions: Through its effectiveness in reducing suicidal ideation and improving the clinical dimensions associated with suicidal risk in patients suffering from a suicidal behavior disorder, ACT could be developed as an adjunctive strategy in programs for suicide prevention. [ABSTRACT FROM AUTHOR]

This paper presents findings from a multi-centre, double-blind, randomized controlled trial that tested the hypothesis that parent and youth mental health improvements would be superior in a family-based intervention for adolescent depression (BEST MOOD) compared to a treatment-as-usual supportive parenting program (PAST). Eligible participants were families with a young person aged between 12 and 18 years who met diagnostic criteria for a depressive disorder (major, minor or dysthymic). Participating families (N = 64; 73.4% of youth were female) were recruited in Victoria, Australia and allocated to treatment condition using a block randomization procedure (parallel design) with two levels of blinding. This paper reports on the trial's secondary outcomes on youth and parent mental health. General linear mixed models were used to examine the longitudinal effect of treatment group on outcome. Data were analyzed according to intention-to-treat; 31 families were analyzed in BEST MOOD, and 33 families in PAST. Parents in the BEST MOOD group experienced significantly greater reductions in stress and depressive symptoms than parents in the PAST group at 3-month follow-up. A greater reduction in parental anxiety was observed in the BEST MOOD group (d = 0.35) compared with PAST (d = 0.02), although the between-group difference was not significant. Both groups of youth showed similar levels of improvement in depressive symptoms at post-treatment (d = 0.83 and 0.80 respectively), which were largely sustained at a 3-month follow-up. The family-based BEST MOOD intervention appeared superior to treatment-as-usual (PAST) in demonstrating greater reductions in parental stress and depression. Both interventions produced large reductions in youth depressive symptoms. [ABSTRACT FROM AUTHOR]

Background: Behavioral activation (BA) and acceptance and commitment therapy (ACT) are considered particularly useful treatments when dealing with emotional problems of cancer survivors. The efficacy of these two treatments, applied on a group basis, were evaluated and compared. Method: An analysis was carried out of pre-post treatment changes in the emotional state and patterns of activation/avoidance of 52 cancer patients, with anxiety and/or depression, randomly assigned to three groups (BA/ ACT/waiting list control). Results: Both therapies were superior to no treatment in all the variables evaluated. Significant differences were found between the two treatments in favor of ACT in social impairment and avoidance/rumination. Conclusions: BA and ACT, applied on a group basis, are efficacious in the treatment of those emotional difficulties most prevalent in cancer survivors. Results suggest that activation and avoidance are the mechanisms responsible for the changes. [ABSTRACT FROM AUTHOR]

Evidence supports exercise as an intervention for many mental health concerns; however, randomized controlled investigations of the efficacy of different exercise modalities and predictors of change are lacking. The purposes of the current trial were to: (1) quantify the effects of aerobic exercise and resistance training on anxiety-related disorder (including anxiety disorders, obsessive-compulsive disorder, and posttraumatic stress disorder) status, symptoms, and constructs, (2) evaluate whether both modalities of exercise were equivalent, and (3) to determine whether exercise enjoyment and physical fitness are associated with symptom reduction. A total of 48 individuals with anxiety-related disorders were randomized to aerobic exercise, resistance training, or a waitlist. Symptoms of anxiety-related disorders, related constructs, and exercise enjoyment were assessed at pre-intervention and weekly during the 4-week intervention. Participants were further assessed 1-week and 1-month post-intervention. Both exercise modalities were efficacious in improving disorder status. As well, aerobic exercise improved general psychological distress and anxiety, while resistance training improved disorder-specific symptoms, anxiety sensitivity, distress tolerance, and intolerance of uncertainty. Physical fitness predicted reductions in general psychological distress for both types of exercise and reductions in stress for aerobic exercise. Results highlight the efficacy of different exercise modalities in uniquely addressing anxiety-related disorder symptoms and constructs. [ABSTRACT FROM AUTHOR]

Background: Pregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well documented that exercise improves psychological well-being in nonpregnant subjects with symptoms of depression. However, in only a few small studies have researchers examined the effect of exercise on symptoms of depression among pregnant women. We hypothesize that physiotherapist-supervised group exercise for pregnant women at risk of antenatal depression increases their psychological well-being. This paper describes the study protocol of a randomized controlled trial (RCT) on a supervised group exercise intervention for pregnant women with a current or previous history of depression and/or anxiety.Methods/design: The RCT is being carried out at the Department of Obstetrics, Rigshospitalet, Copenhagen University Hospital, in the period 2016-2019. The inclusion criteria are pregnant women ≥18 years of age with depression and/or anxiety requiring treatment by a psychiatrist or a psychologist within the last 10 years and/or intake of antidepressants in the 3 months prior to conception and/or during pregnancy. The women must have appropriate Danish language skills, be pregnant with a single fetus, give written informed consent, and be at 17-22 gestational weeks when the intervention begins. The primary outcome is psychological well-being (the five-item World Health Organization Well-being Index). Secondary outcomes are symptoms of depression (Edinburgh Postnatal Depression Scale), functional ability (General Health Questionnaire), clinical symptoms of anxiety (State-Trait Anxiety Inventory), sleep quality and sleep disturbances (Pittsburgh Sleep Quality Index), and pregnancy and delivery outcomes. The intervention is supervised group exercise twice weekly for 12 weeks. The control group will receive standard antenatal care. On the basis of sample size calculation, a total of 300 women will be randomly assigned to either the intervention or the control group in a ratio of 1:1.Discussion: The trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression.Trial Registration: ClinicalTrials.gov, NCT02833519 . Registered on 19 May 2016. [ABSTRACT FROM AUTHOR]

Background: Research suggests that the positive affect system may be an important yet underexplored treatment target in anxiety and depression. Existing interventions primarily target the negative affect system, yielding modest effects on measures of positive emotions and associated outcomes (e.g., psychological well-being). The objective of the present pilot study was to evaluate the efficacy of a new transdiagnostic positive activity intervention (PAI) for anxiety and depression.Method: Twenty-nine treatment-seeking individuals presenting with clinically impairing symptoms of anxiety and/or depression were randomly allocated to a 10-session protocol comprised of PAIs previously shown in nonclinical samples to improve positive thinking, emotions, and behaviors (e.g., gratitude, acts of kindness, optimism; n = 16) or a waitlist (WL) condition (n = 13). Participants were assessed at pre- and posttreatment, as well as 3- and 6-month follow-up, on measures of positive and negative affect, symptoms, and psychological well-being. ClinicalTrials.gov Identifier: NCT02330627 RESULTS: The PAI group displayed significantly larger improvements in positive affect and psychological well-being from pre- to posttreatment compared to WL. Posttreatment and follow-up scores in the PAI group were comparable to general population norms. The PAI regimen also resulted in significantly larger reductions in negative affect, as well as anxiety and depression symptoms, compared to WL. Improvements across all outcomes were large in magnitude and maintained over a 6-month follow-up period.Conclusions: Targeting the positive affect system through a multicomponent PAI regimen may be beneficial for generating improvements in positive emotions and well-being, as well as reducing negative affect and symptoms, in individuals with clinically impairing anxiety or depression. [ABSTRACT FROM AUTHOR]

Background: Anxiety is the most common negative emotion among the patients awaiting coronary angiography. The increased anxiety may exacerbate coronary heart disease symptoms and possibly contribute to complications during the procedure. Chinese hand massage is a nonpharmaceutical intervention that has been used in several clinical situations in China and might have beneficial effects on reducing anxiety before coronary angiography. Objective: The aim of this study was to evaluate the effectiveness and safety of Chinese hand massage care on anxiety among patients awaiting coronary angiography. Methods: One hundred eighty-five subjects awaiting coronary angiography in a single hospital in Fuzhou, China, between May 2012 and September 2012 were screened. One hundred eligible participants were recruited and randomly assigned into the control or Chinese hand massage group. The control group received the conventional therapies and care according to the guidelines, and those in the Chinese hand massage group received additional Chinese hand massage care in conjunction with the same conventional therapies and care as the control group. The anxiety scores (evaluated by using the Hamilton Anxiety Rating Scale), heart rate, blood pressure, quality of life (Short-Form Health Survey), and the adverse events were recorded at the baseline and after coronary angiography, respectively. Results: The scores of Hamilton Anxiety Rating Scale in the Chinese hand massage group (11.78 [SD, 2.9]) had a statistically significant decrease compared with those in the control group (15.96 [SD, 3.4]) at post-procedure (P < .01). There was no statistically significant difference on blood pressure, heart rate, and Short-Form Health Survey at postangiography between the Chinese hand massage group and the control group. No adverse event was reported during the intervention period. Conclusions Chinese hand massage effectively alleviated anxiety without any adverse effects among patients awaiting coronary angiography. Therefore, it might be recommended as a nonpharmacological nursing intervention. However, future study with a larger sample size is needed to further confirm the efficacy of Chinese hand massage intervention. [ABSTRACT FROM AUTHOR]

Background: A common alternative treatment for substance abuse is auricular acupuncture. The aim of the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety, sleep, drug use and addiction treatment utilization in adults with substance abuse.Method: Of the patients included, 280 adults with substance abuse and psychiatric comorbidity, 80 were randomly assigned to auricular acupuncture according to the NADA protocol, 80 to auricular acupuncture according to a local protocol (LP), and 120 to relaxation (controls). The primary outcomes anxiety (Beck Anxiety Inventory; BAI) and insomnia (Insomnia Severity Index; ISI) were measured at baseline and at follow-ups 5 weeks and 3 months after the baseline assessment. Secondary outcomes were drug use and addiction service utilization. Complete datasets regarding BAI/ISI were obtained from 37/34 subjects in the NADA group, 28/28 in the LP group and 36/35 controls. Data were analyzed using Chi-square, Analysis of Variance, Kruskal Wallis, Repeated Measures Analysis of Variance, Eta square (η(2)), and Wilcoxon Signed Ranks tests.Results: Participants in NADA, LP and control group improved significantly on the ISI and BAI. There was no significant difference in change over time between the three groups in any of the primary (effect size: BAI, η(2) = 0.03, ISI, η(2) = 0.05) or secondary outcomes. Neither of the two acupuncture treatments resulted in differences in sleep, anxiety or drug use from the control group at 5 weeks or 3 months.Conclusion: No evidence was found that acupuncture as delivered in this study is more effective than relaxation for problems with anxiety, sleep or substance use or in reducing the need for further addiction treatment in patients with substance use problems and comorbid psychiatric disorders. The substantial attrition at follow-up is a main limitation of the study.Trial Registration: Clinical Trials NCT02604706 (retrospectively registered). [ABSTRACT FROM AUTHOR]

The objective of this study was to compare the effects of a multisensory stimulation environment (MSSE) and individualized music sessions on agitation, emotional and cognitive status, and dementia severity in a sample of institutionalized patients with severe dementia. Twenty-two participants with a diagnosis of severe or very severe dementia were randomly assigned to two groups: MSSE and individualized music sessions. Both groups participated in two 30-min weekly sessions over 16 weeks. Outcomes were agitation (Cohen-Mansfield Agitation Inventory, CMAI), mood (Cornell Scale for Depression in Dementia, CSDD), anxiety (Rating Anxiety in Dementia, RAID), cognitive function (Severe Mini-Mental State Examination, SMMSE), and the overall severity of dementia (Bedford Alzheimer Nursing Severity Scale, BANS-S). They were assessed at baseline (pre-trial), in the middle (mid-trial), at the end of the intervention (post-trial), and 8 weeks after the intervention (follow-up). Patients in the MSSE group showed significant improvement in their RAID and BANS-S scores compared with the individualized music group post- versus pre-trial. With regard to agitation, there was improvement during the intervention in both the MSSE and individualized music groups in the CMAI total score after 16 weeks of intervention, with no significant differences between the groups. The results suggest that MSSE could have better effects on anxiety symptoms and dementia severity in comparison with individualized music sessions in elderly patients with severe dementia. [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]

Objective: Multiple chemical sensitivity (MCS) is a medically unexplained condition characterized by symptoms from multiple organ systems following the perception of common odorants. The condition can cause severe functional impairment for afflicted individuals. The aim of this study was to assess the effects of mindfulness-based cognitive therapy (MBCT) for individuals with MCS.Methods: The intention-to-treat sample (ITT) included 69 individuals who had been randomized to either MBCT or treatment as usual (TAU). The primary outcome measure was the Quick Environmental Exposure and Sensitivity Inventory (QEESI), which measures the following aspects ofMcs: impact of MCS on daily life, symptoms, and reactions following chemical exposures. Secondary outcome measures included the Brief Illness Perception Questionnaire (BIPQ) and the anxiety and depression subscales of the symptom checklist 92 (SCL-92). Participants were assessed at baseline and post treatment, and at follow-up periods of 6- and 12-months.Results: We found no effect of MBCT on the primary outcome, nor did we find an effect on levels of depression or anxiety. We did, however, find positive changes in illness perceptions, which were sustained at 12-month follow-up. Dropout rates were low, suggesting MBCT was well received and regarded as an acceptable intervention by individuals with MCS.Conclusions: Overall, these results suggest that MBCT does not change overall illness status in individuals with MCS, but that MBCT positively changes emotional and cognitive representations. Possible explanations for these results are discussed. [ABSTRACT FROM AUTHOR]

Background: Mental health disorders are common and disabling for young people because of the potential to disrupt key developmental tasks. Implementation of evidence-based psychosocial therapies in New Zealand is limited, owing to the inaccessibility, length, and cost of training in these therapies. Furthermore, most therapies address one problem area at a time, although comorbidity and changing clinical needs commonly occur in practice. A more flexible approach is needed. The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC) is designed to overcome these challenges; it provides a range of treatment modules addressing different problems, within a single training program. A clinical trial of MATCH-ADTC in the USA showed that MATCH-ADTC outperformed usual care and standard evidence-based treatment on several clinical measures. We aim to replicate these findings and evaluate the impact of providing training and supervision in MATCH-ADTC to: (1) improve clinical outcomes for youth attending mental health services; (2) increase the amount of evidence-based therapy content; (3) increase the efficiency of service delivery.Methods: This is an assessor-blinded multi-site effectiveness randomized controlled trial. Randomization occurs at two levels: (1) clinicians (≥60) are randomized to intervention or usual care; (2) youth participants (7-14 years old) accepted for treatment in child and adolescent mental health services (with a primary disorder that includes anxiety, depression, trauma-related symptoms, or disruptive behavior) are randomly allocated to receive MATCH-ADTC or usual care. Youth participants are recruited from 'mainstream', Māori-specific, and Pacific-specific child and adolescent mental health services. We originally planned to recruit 400 youth participants, but this has been revised to 200 participants. Centralized computer randomization ensures allocation concealment. The primary outcome measures are: (i) the difference in trajectory of change of clinical severity between groups (using the parent-rated Brief Problem Monitor); (ii) clinicians' use of evidence-based treatment procedures during therapy sessions; (iii) total time spent by clinicians delivering therapy.Discussion: If MATCH-ADTC demonstrates effectiveness it could offer a practical efficient method to increase access to evidence-based therapies, and improve outcomes for youth attending secondary care services.Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12614000297628 . [ABSTRACT FROM AUTHOR]

Background: Solid organ transplant patients often experience a variety of psychosocial stressors that can lead to distress and may hinder successful recovery. Using coping-infused dialogue (CID) through patient- preferred live music (PPLM) music therapy sessions may improve mood and decrease pain while also imparting psychoeducational knowledge concerning the identification of local and global problems and coping skills.Objective: The purpose of this pilot study was to develop a coping-based medical music therapy protocol that combines coping-infused dialogue (CID) with patient-preferred live music (PPLM) and measure the effects of the resulting CID-PPLM protocol on mood (positive and negative affect) and pain in hospitalized transplant patients.Methods: Our study used a pre-/posttest single-session wait-list control design. Participants (N=25) were randomly assigned to experimental (CID-PPLM) or control (usual care) conditions. Participants in the CID-PPLM condition received a single 30-minute session that integrated stressor identification and knowledge of coping skills (CID) with patient-preferred live music (PPLM).Results: Results indicated no between-group differences at pretest and significant correlations between pre- and posttest measures. Concerning posttest ANCOVA analyses, there were significant between-group differences in positive affect, negative affect, and pain, with experimental participants having more favorable posttest scores than control participants. Effect sizes were in the medium-to-large range for positive affect (η2=.198), negative affect (η2=.422), and pain (η2=.303).Conclusions: CID through receptive PPLM may be an effective protocol for improving mood and decreasing pain in organ transplant recipients. MT interventions can be an important tool to develop rapport and enhance outcomes with patients. As greater engagement during interventions may have stronger treatment effects, we recommend future research examining patient engagement as a potential mediator of intervention effects, as well as the number of sessions required to maximize clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: The wearing-off phenomenon in patients with Parkinson's disease (PD) is a complication of prolonged levodopa usage. During this phenomenon, motor symptoms such as rigidity and freezing re-emerge. This is often accompanied by non-motor symptoms, including anxiety, the so-called wearing-off related anxiety (WRA). Current treatment options are limited and typically focus on either the physical or mental aspects of wearing-off. An integrated approach seems warranted in order to optimally address the complex reciprocal interactions between these aspects. Also, because wearing-off is eventually inescapable, treatment needs to focus on coping, acceptance, and self-efficacy. We therefore developed an integrated body awareness intervention, combining principles from physical therapy with acceptance and commitment therapy to teach patients to deal with WRA. This study will investigate whether this new intervention, named BEWARE, is more effective than treatment as usual in increasing self-efficacy.Methods/design: This is a single-blinded randomized controlled trial in 36 PD patients who experience WRA. Subjects will be recruited from the outpatient clinic for movement disorders of the VU University Medical Center. After providing written informed consent, patients will be randomly assigned to an experimental (BEWARE) or treatment-as-usual (physical therapy) group. Clinical assessments will be performed prior to the intervention, directly after the 6-week intervention period, and at 3-month naturalistic follow-up by a blinded investigator not involved in the study. The primary outcome measure is self-efficacy, and secondary outcomes focus on mobility, daily functioning, anxiety, and quality of life.Discussion: Because wearing-off is an inevitable consequence of levodopa therapy and current treatment options are insufficient, a multidisciplinary intervention that addresses both physical and mental aspects of wearing-off in PD may foster additional benefits for treating WRA in PD patients over mono-disciplinary care alone.Trial Registration: ClinicalTrials.gov identifier: NCT02054845. Date of registration: 30 January 2014. [ABSTRACT FROM AUTHOR]

Background: Prevalence estimates for depression and anxiety in individuals post-stroke are approximately 33 and 29%, yet there are few effective preventive interventions. Interventions which commence pre-discharge and continue during the early post-discharge period may support individuals during the critical transition to home adjustment period. This study aimed to evaluate the efficacy of a self-management intervention and a coping skills intervention, compared to usual care, on anxiety and depression post-stroke. Methods: A pilot, three-arm randomized trial involving 33 stroke patients (coping skills: n511, self-management: n512, usual care: n510) recruited from an Australian stroke unit. Both interventions were eight 1- hour weekly sessions, with the first two pre-discharge and the remainder at home; targeted both anxiety and depression; and tailored content to individuals. Primary outcome was severity of depressive and anxiety symptoms (measured using Montgomery andÅsberg Depression Rating Scale and Hospital Anxiety and Depression Scale). Secondary measures were: self-efficacy, stroke knowledge, basic and extended activities of daily living, and quality of life. Outcome measures were administered at baseline, one week post-intervention, and at a three month follow-up by a blinded assessor. Results: Thirty (91%) participants completed the trial. Immediately post-intervention there was a small improvement in stroke knowledge and a small increase in depression symptoms (on one of the two measures of depression symptoms) in the coping skills group compared to usual care. These differences did not remain significant at the 3-month follow-up, nor were there any other significant differences. Conclusion: Neither a coping skills nor self-management intervention reduced anxiety nor depression symptoms early post-stroke more than usual care. Lack of statistical power may have contributed to the non-significant findings in this pilot study. [ABSTRACT FROM AUTHOR]

Objective: Recently, innovative statistical tools have been used to model patterns of change in psychological treatments. These tools can detect patterns of change in patient progress early in treatment and allow for the prediction of treatment outcomes and treatment length. Method: We used growth mixture modeling to identify different latent classes of early change in patients with panic disorder (N = 326) who underwent a manualized cognitive-behavioral treatment. Results: Four latent subgroups were identified, showing clusters of change trajectories over the first 5 sessions. One of the subgroups consisted of patients whose symptoms rapidly decreased and also showed the best outcomes. This information improved treatment prediction by 16.1% over patient intake characteristics. Early change patterns also significantly predicted patients' early treatment termination. Patient intake characteristics that significantly predicted class membership included functional impairment and separation anxiety. Conclusions: These findings suggest that early treatment changes are uniquely predictive of treatment outcome. [ABSTRACT FROM AUTHOR]

Mindfulness-based interventions have proven effective for the transdiagnostic treatment of heterogeneous anxiety disorders. So far, no study has investigated the potential of mindfulness-based treatments when delivered remotely via the Internet. The current trial aims at evaluating the efficacy of a stand-alone, unguided, Internet-based mindfulness treatment program for anxiety. Ninety-one participants diagnosed with social anxiety disorder, generalized anxiety disorder, panic disorder, or anxiety disorder not otherwise specified were randomly assigned to a mindfulness treatment group (MTG) or to an online discussion forum control group (CG). Mindfulness treatment consisted of 96 audio files with instructions for various mindfulness meditation exercises. Primary and secondary outcome measures were assessed at pre-, posttreatment, and at 6-months follow-up. Participants of the MTG showed a larger decrease of symptoms of anxiety, depression, and insomnia from pre- to postassessment than participants of the CG (Cohen’s d between = 0.36-0.99). Within effect sizes were large in the MTG ( d = 0.82–1.58) and small to moderate in the CG ( d = 0.45–0.76). In contrast to participants of the CG, participants of the MTG also achieved a moderate improvement in their quality of life. The study provided encouraging results for an Internet-based mindfulness protocol in the treatment of primary anxiety disorders. Future replications of these results will show whether Web-based mindfulness meditation can constitute a valid alternative to existing, evidence-based cognitive-behavioural Internet treatments. The trial was registered at ClinicalTrials.gov (NCT01577290). [ABSTRACT FROM AUTHOR]

Abstract: Grandparents providing regular child care to grandchildren contribute to the nurturing environment in which children are raised. This study evaluated the efficacy of a behavioral family intervention designed specifically for grandparents, Grandparent Triple P. Fifty-four grandparents (M = 60.89) and 48 parents (M = 34.52) participated in the evaluation. Grandparents predominantly provided between 12 and 20 h of care per week (64.81%), to a grandchild (62% male) aged between 2 and 9 years (M = 4.42). Families were randomly assigned to one of two conditions (intervention or grandparent care-as-usual) and were assessed using a multiple informant approach at three time points (preintervention, postintervention, and six-month follow-up). Relative to the grandparent care-as-usual group, significant short-term improvements were found in the intervention group on grandparent-reported child behavior problems; parenting confidence; grandparent depression, anxiety, stress; and improved relationship with the parent. Parents also reported significant reductions in child behavior problems, despite not participating in the program. Short-term effects were predominantly maintained at six-month follow-up. [Copyright &y& Elsevier]

Preclinical studies suggest that substance P acting at neurokinin 1 (NK1) receptors may be involved in stress responses and NK1 receptor antagonists show activity in tests of anxiety. These data raise the possibility that NK1 receptor antagonists could be potential anxiolytic treatments in humans. We evaluated this hypothesis clinically using the NK1 antagonist L-759274. This is a randomized, double-blind, placebo- and active-controlled, multicentre, proof-of-concept trial. Patients with generalized anxiety disorder were randomized 1:1:1 to 6 wk of treatment with 40 mg L-759274 (n = 73), 1–6 mg lorazepam (n = 69) or placebo (n = 71). Efficacy was assessed using the Hamilton Anxiety Scale (HAMA). A positron emission tomography (PET) study was also performed in 16 healthy subjects to determine the relationship between NK1 receptor occupancy and plasma levels of L-759274 to verify adequate target engagement by the doses tested during the clinical trial. No statistically significant difference in mean change from baseline HAMA score at 6 wk was seen for L-759274 vs. placebo [difference = 1.0 (95% confidence intervals (CI) −1.2 to 3.2), p = 0.359] whereas the lorazepam group did show a significant improvement vs. placebo (difference = −2.7, 95% CI −5.0 to −0.4, p = 0.020) and L-759274 (difference = 3.7, 95% CI 1.5–6.0, p = 0.001]. Results from the PET study indicated that the L-759274 dosing regimen used in the clinical trial likely provided high levels of NK1 receptor occupancy (>90%), supporting the view that it was an adequate proof-of-concept trial. The NK1 receptor antagonist L-759274 does not appear to be efficacious for the treatment of generalized anxiety disorder. [ABSTRACT FROM AUTHOR]

Background: Available treatments for anxiety have limitations and/or side effects. The aim of this study was to examine the influence of bright light exposure as a treatment in high-anxious young adults. Methods: In an acute exposure study, participants (n = 33) were randomly assigned to 45 min of (1) bright light or (2) placebo. Participants then performed a 5-week study (n = 29). Following a 1-week baseline, participants were randomly assigned to 4 weeks of daily exposure to either (1) bright light (45 min/day) or (2) placebo treatment, initiated ≤1 hr after awakening. Before and after the experiment, clinical ratings were conducted with the Hamilton Anxiety Scale (HAM-A), Hamilton Depression Scale, and Clinical Global Impressions scale. Following each week, blood pressure, anxiety (Spielberger State-Trait Anxiety Inventory Y1), depression, mood, sleep, and side effects were assessed. Results: No significant treatment effect was found in the acute exposure study. Likewise, in the 5-week study, no significant treatment effect was found. However, bright light elicited marginally greater reductions in psychic symptoms of the HAM-A (P = .06) and other measures. Conclusions: This pilot study provides little compelling evidence for an anxiolytic effect of bright light in high-anxious young adults. Depression and Anxiety, 2011. © 2011 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

Background: Low-intensity self-guided mental health interventions that are delivered on the web may meet the needs and preferences of adults with mild to moderate symptoms. However, few clinical trials have examined the effectiveness of self-guided transdiagnostic interventions within a naturalistic setting.Objective: This randomized controlled trial (RCT) tests the effectiveness of the video-based transdiagnostic intervention FitMindKit in reducing depression symptoms (primary outcome), anxiety symptoms, disability, and suicidal ideation, relative to an attention-matched control condition called HealthWatch.Methods: The RCT was conducted with adults living in the Australian Capital Territory, Australia. Participants (n=1986) were recruited through the web using social media advertisements, screened for psychological distress, and then randomized to receive one of two 4-week programs: FitMindKit (12-module psychotherapy intervention) or HealthWatch (12-module program providing general health information). Participants were assessed at baseline and at 4 weeks postbaseline. To maintain the ecological validity of the trial, participants completed brief assessments and interventions without direct researcher contact or incentives.Results: Mixed model repeated-measures analyses of variance demonstrated that FitMindKit significantly improved depression symptoms (F1,701.7=3.97; P=.047), along with panic symptoms (F1,706.5=5.59; P=.02) and social anxiety symptoms (F1,680.0=12.37; P<.001), relative to the attention control condition. There were no significant effects on other outcomes.Conclusions: Self-guided transdiagnostic interventions can be beneficial when delivered directly to end users through the internet. Despite low adherence and small effect sizes, the availability of such interventions is likely to fill a critical gap in the accessibility of mental health services for the community.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001688279; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376113.International Registered Report Identifier (irrid): RR2-10.1016/j.conctc.2019.100341. [ABSTRACT FROM AUTHOR]

Background: Nursing students all over the world experience high levels of stress with negative impacts on their health, emotional state and performance. Aim: This study aimed to investigate the effects of distraction‐focused interventions on examination stress and anxiety in nursing students. Methods: A randomized controlled, parallel trial design was conducted from January to June 2016. After baseline measurement, 72 participants were randomized to one of the following groups (n = 18 each): (i) animal‐assisted therapy; (ii) music therapy; (iii) mandala painting; (iv) control group. Outcomes of all groups in terms of stress‐reduction were compared by measuring self‐reported perceived stress (STAI‐State and visual analogue stress scale) and salivary biomarker levels (Cortisol and Immunoglobulin A). Results: Fifty‐seven complete data sets (n = 12‐16 for each group) were analysed. All distraction‐focused interventions showed stress and anxiety reduction in everyday school situations. By contrast, on days with examinations, stress reductions did not reach statistical significance in regard to self‐reported psychological stress. At the same time, interventions resulted in significantly decreased levels of stress biomarkers (P <.001). Conclusions: Our preliminary findings suggest positive but situation‐dependent effects of distraction‐focused interventions in academic settings. Further research should investigate the complex relationship between physiological and psychological stress parameters. [ABSTRACT FROM AUTHOR]

Background: Up to 60% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) meet diagnostic criteria for at least one anxiety disorder, including Social, Generalized and/or Separation Disorder. Anxiety in children with ADHD has been shown to be associated with poorer child and family functioning. Small pilot studies suggest that treating anxiety in children with ADHD using cognitive-behavioral therapy (CBT) has promising benefits. In a fully powered randomized controlled trial (RCT), we aim to investigate the efficacy of an existing CBT intervention adapted for children with ADHD and comorbid anxiety compared with usual care. Methods: This RCT is recruiting children aged 8–12 years (N = 228) from pediatrician practices in Victoria, Australia. Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social). Eligible children are randomized to receive a 10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician. The intervention focuses on building child and parent skills and strategies to manage anxiety and associated impairments including cognitive restructuring and graded exposure. Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities. The primary outcome is change in the proportion of children meeting diagnostic criteria for an anxiety disorder at 5 months randomization. This will be assessed via diagnostic interview with the child's parent (Anxiety Disorders Interview Schedule for Children V) conducted by a researcher blinded to intervention condition. Secondary outcomes include a range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed at 5 and 12 months post-randomization. Outcomes will be analyzed using logistic and mixed effects regression. Discussion: The results from this study will provide evidence on whether treating comorbid anxiety in children with ADHD using a CBT approach leads to improvements in anxiety and/or broader functional outcomes. Trial registration: This trial was prospectively registered: Current Controlled Trials ISRCTN59518816 (10.1186/ISRCTN59518816). The trial was first registered 29/9/15 and last updated 15/1/19. [ABSTRACT FROM AUTHOR]

Background: Mental well-being could be promoted and protected by positive psychology (PP) based interventions. Such interventions may be appealing for people at risk of anxiety and depressive disorders, but health-economic evaluations are scarce. The aim was to examine the cost-effectiveness of a PP intervention. Methods: Participants with suboptimal levels of mental well-being were randomly assigned to an email guided PP-intervention (n = 137) or a wait-list control group (n = 138) with access to usual care (UC). At baseline and 6 months follow-up, data were collected on health care costs. Outcomes of interest were flourishing mental health and treatment response on anxiety and depressive symptoms. Results: Bootstrapped mean incremental cost-effectiveness ratios were €2359 ($2899) for flourishing, €2959 ($3637) for anxiety and €2578 ($3168) for depression, suggesting appreciable health gains for low additional costs. At a willingness to pay ceiling of €10,000 ($12,290) for a treatment response, the probability that the intervention is deemed cost-effective ranged between 90 and 93%. Conclusions: The guided PP intervention appears to be a promising strategy as seen from both a public health and a health-economic perspective, especially when there is some willingness to pay. When the PP-intervention is scaled up, then outcome monitoring is recommended to better guarantee the longer term cost-effectiveness of the intervention. Trial registration: The Netherlands National Trial Register NTR4297. Registered on 29 November 2013. The NTR is part of the WHO Primary Registries. [ABSTRACT FROM AUTHOR]