Guided internet-based LGBTQ-affirmative cognitive-behavioral therapy: A randomized controlled trial among sexual minority men in China.

OBJECTIVE: LGBTQ-affirmative cognitive-behavioral therapy (CBT) addresses minority stress to improve sexual minority individuals' mental and behavioral health. This treatment has never been tested in high-stigma contexts like China using online delivery. METHOD: Chinese young sexual minority men (n = 120; ages 16-30; HIV-negative; reporting depression and/or anxiety symptoms and past-90-day HIV-transmission-risk behavior), were randomized to receive 10 sessions of culturally adapted asynchronous LGBTQ-affirmative internet-based CBT (ICBT) or weekly assessments only. The primary outcome included HIV-transmission-risk behavior (i.e., past-30-day condomless anal sex). Secondary outcomes included HIV social-cognitive mechanisms (e.g., condom use self-efficacy), mental health (e.g., depression), and behavioral health (e.g., alcohol use), as well as minority stress (e.g., acceptance concerns), and universal (e.g., emotion regulation) mechanisms at baseline and 4- and 8-month follow-up. Moderation analyses examined treatment efficacy as a function of baseline stigma experiences and session completion. RESULTS: Compared to assessment only, LGBTQ-affirmative ICBT did not yield greater reductions in HIV-transmission-risk behavior or social-cognitive mechanisms. However, LGBTQ-affirmative ICBT yielded greater improvements in depression (d = -0.50, d = -0.63) and anxiety (d = -0.51, d = -0.49) at 4- and 8-month follow-up, respectively; alcohol use (d = -0.40) at 8-month follow-up; and certain minority stress (e.g., internalized stigma) and universal (i.e., emotion dysregulation) mechanisms compared to assessment only. LGBTQ-affirmative ICBT was more efficacious for reducing HIV-transmission-risk behavior for participants with lower internalized stigma (d = 0.42). Greater session completion predicted greater reductions in suicidality and rumination. CONCLUSIONS: LGBTQ-affirmative ICBT demonstrates preliminary efficacy for Chinese young sexual minority men. Findings can inform future interventions for young sexual minority men in contexts with limited affirmative supports.

Cognitive Behavioral Therapy for Symptom Preoccupation Among Patients With Premature Ventricular Contractions: Nonrandomized Pretest-Posttest Study.

BACKGROUND: Premature ventricular contractions (PVCs) are a common cardiac condition often associated with disabling symptoms and impaired quality of life (QoL). Current treatment strategies have limited effectiveness in reducing symptoms and restoring QoL for patients with PVCs. Symptom preoccupation, involving cardiac-related fear, hypervigilance, and avoidance behavior, is associated with disability in other cardiac conditions and can be effectively targeted by cognitive behavioral therapy (CBT). OBJECTIVE: The aim of this study was to evaluate the effect of a PVC-specific CBT protocol targeting symptom preoccupation in patients with symptomatic idiopathic PVCs. METHODS: Nineteen patients diagnosed with symptomatic idiopathic PVCs and symptom preoccupation underwent PVC-specific CBT over 10 weeks. The treatment was delivered by a licensed psychologist via videoconference in conjunction with online text-based information and homework assignments. The main components of the treatment were exposure to cardiac-related symptoms and reducing cardiac-related avoidance and control behavior. Self-rated measures were collected at baseline, post treatment, and at 3- and 6-month follow-ups. The primary outcome was PVC-specific QoL at posttreatment assessment measured with a PVC-adapted version of the Atrial Fibrillation Effects on Quality of Life questionnaire. Secondary measures included symptom preoccupation measured with the Cardiac Anxiety Questionnaire. PVC burden was evaluated with 5-day continuous electrocardiogram recordings at baseline, post treatment, and 6-month follow-up. RESULTS: We observed large improvements in PVC-specific QoL (Cohen d=1.62, P<.001) and symptom preoccupation (Cohen d=1.73, P<.001) post treatment. These results were sustained at the 3- and 6-month follow-ups. PVC burden, as measured with 5-day continuous electrocardiogram, remained unchanged throughout follow-up. However, self-reported PVC symptoms were significantly lower at posttreatment assessment and at both the 3- and 6-month follow-ups. Reduction in symptom preoccupation had a statistically significant mediating effect of the intervention on PVC-specific QoL in an explorative mediation analysis. CONCLUSIONS: This uncontrolled pilot study shows preliminary promising results for PVC-specific CBT as a potentially effective treatment approach for patients with symptomatic idiopathic PVCs and symptom preoccupation. The substantial improvements in PVC-specific QoL and symptom preoccupation, along with the decreased self-reported PVC-related symptoms warrant further investigation in a larger randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05087238; https://clinicaltrials.gov/study/NCT05087238.

Shared and distinct effect mediators in exposure-based and traditional cognitive behavior therapy for fibromyalgia: Secondary analysis of a randomized controlled trial.

Fibromyalgia is a chronic pain condition associated with substantial suffering and societal costs. Traditional cognitive behavior therapy (T-CBT) is the most evaluated psychological treatment, but exposure therapy (Exp-CBT) has shown promise with a pronounced focus on the reduction of pain-related avoidance behaviors. In a recent randomized controlled trial (N = 274), we found that Exp-CBT was not superior to T-CBT (d = -0.10) in reducing overall fibromyalgia severity. This study investigated pain-related avoidance behaviors, pain catastrophizing, hypervigilance, pacing, overdoing and physical activity as potential mediators of the treatment effect. Mediation analyses were based on parallel process growth models fitted on 11 weekly measurement points, and week-by-week time-lagged effects were tested using random intercepts cross-lagged panel models. Results indicated that a reduction in avoidance behaviors, pain catastrophizing, and hypervigilance were significant mediators of change in both treatments. An increase in pacing and a reduction in overdoing were significant mediators in T-CBT only. Physical activity was not a mediator. In the time-lagged analyses, an unequivocal effect on subsequent fibromyalgia severity was seen of avoidance and catastrophizing in Exp-CBT, and of overdoing in T-CBT. Exposure-based and traditional CBT for fibromyalgia appear to share common treatment mediators, namely pain-related avoidance behavior, catastrophizing and hypervigilance.

Effectiveness of internet-delivered cognitive behavioural therapy for anxiety and obsessive-compulsive disorders within routine clinical care in rural Sweden.

Few studies have evaluated the implementation of ICBT in regular child and adolescent mental health services (CAMHS). This study aimed to explore the acceptability, feasibility, and effectiveness of ICBT for children and adolescents with anxiety disorders and obsessive-compulsive disorder (OCD) within a rural CAMHS. The study also explored outcome predictors and long-term outcomes. Eighty-three participants were consecutively recruited from a non-specialized CAMHS in Region Jämtland Härjedalen in northern Sweden. Therapist-guided ICBT was offered during 12 weeks to children aged 8-17 with an anxiety disorder or OCD. Acceptability and feasibility measures included treatment adherence, treatment satisfaction, and adverse events. The primary outcome measure was the Clinical Global Impression-Severity. Secondary measures of effectiveness included clinician-, self-, and parent-ratings of symptom severity and functional impairment. Assessments were completed at baseline, post-treatment, and three-month follow-up (primary endpoint). A two-year follow up was conducted using medical records. Potential predictors included both patient characteristics and treatment variables. Results indicated that ICBT was both acceptable and feasible according to study measures. Statistically significant improvements were found from baseline to the three-month follow-up on clinician rated severity (B [SE] = -0.92 [0.09]; p < .001), as well as on all secondary measures. Forty-three percent of participants no longer fulfilled criteria for their principal disorder at the three-month follow-up. No serious adverse events were reported. Clinical improvement was highest among children with higher functioning at baseline (B [SE] = -0.05 [0.02]; p < .05). Forty-six percent of participants had been in contact with CAMHS during the two-year follow-up period, mainly for reasons other than their initial diagnosis. Findings suggest that ICBT could be an acceptable and feasible treatment option for young people with anxiety disorders and OCD in rural non-specialized CAMHS settings. Further studies are needed to confirm treatment effectiveness in this setting. Trial registration: NCT02926365.

[CBT administered via the internet]. / Internetförmedlad psykologisk egenvård.

Cognitive behavioral therapy (CBT) can be administered clinically to individuals and in group settings. More recently, CBT has been administered successfully via the internet (ICBT). We provide a concept aiming at further developing ICBT in a self-care format. We use recent development in user interface (UI) design in order to optimize the user interface and allow easy and flexible use via smartphone, tablet, or computer. Preliminary evidence indicates that an optimized user interface and adjusted information facilitate increased use of training programs compared to a traditional ICBT interface. Our aims are to allow increased availability of evidence-based CBT tools for self-care to improve people's health and recovery from disease. So far, evidence for effects and safe use is indicated for atopic dermatitis, insomnia and high-risk use of alcohol.

Cognitive-behavioral therapy for avoidant/restrictive food intake disorder: A proof-of-concept for mechanisms of change and target engagement.

BACKGROUND: Cognitive-behavioral therapy for avoidant/restrictive food intake disorder (ARFID; CBT-AR) theoretically targets three prototypic motivations (sensory sensitivity, lack of interest/low appetite, fear of aversive consequences), aligned with three modularized interventions. As an exploratory investigation, we: (1) evaluated change in candidate mechanisms in relationship to change in ARFID severity, and (2) tested if assignment (vs. not) to a module resulted in larger improvements in the corresponding mechanism. METHOD: Males and females (N = 42; 10-55 years) participated in an open trial of CBT-AR. RESULTS: Decreases in scaled scores for each candidate mechanism had medium to large correlations with decreases in ARFID severity-sensory sensitivity: -0.7 decrease (r = .42, p = .01); lack of interest/low appetite: -0.3 decrease (r = .60, p < .0001); and fear of aversive consequences: -1.1 decrease (r = .33, p = .05). Linear mixed models revealed significant weekly improvements for each candidate mechanism across the full sample (ps < .0001). There were significant interactions for the sensory and fear of aversive consequences modules-for each, participants who received the corresponding module had significantly larger decreases in the candidate mechanism than those who did not receive the module. DISCUSSION: Sensory sensitivity and fear of aversive consequences improved more if the CBT-AR module was received, but lack of interest/low appetite may improve regardless of receipt of the corresponding module. Future research is needed to test target engagement in CBT-AR with adaptive treatment designs, and to identify valid and sensitive measures of candidate mechanisms. PUBLIC SIGNIFICANCE: The mechanisms through which components of CBT-AR work have yet to be elucidated. We conducted an exploratory investigation to test if assignment (vs. not) to a CBT-AR module resulted in larger improvements in the corresponding prototypic ARFID motivation that the module intended to target. Measures of the sensory sensitivity and the fear of aversive consequences motivations improved more in those who received the corresponding treatment module, whereas the lack of interest/low appetite measure improved regardless of if the corresponding module was received.

Ashtangayoga for irritable bowel syndrome in a primary care setting: A feasibility study.

BACKGROUND: Irritable bowel syndrome (IBS) is a common gastrointestinal disorder characterized by diarrhea or constipation and other symptoms such as pain, bloating, and flatulence. The disease often has a negative effect on quality of life and is also associated with symptoms of anxiety and depression. Pharmacological treatments are not always effective, and complementary and alternative treatments are common. METHODS: We conducted a study on a group intervention based on the Ashtanga school of yoga. Fourteen participants (three men, 11 women; average age 51.4, SD = 16) were recruited from primary care, and 10 completed treatment. At pre-measurement, 4 participants had severe, 9 moderate, and 1 mild IBS, according to the IBS-SSS scale. KEY RESULTS: The intervention was regarded as credible (CEQ M = 39.2 SD = 8.8), and no serious adverse events were reported. The intervention showed significant effects on all measurements at post, as follows: IBS-SSS PRE (M = 272.0 SD = 75.5); IBS-SSS POST (M = 177.0 SD = 103.5); GSRS-IBS PRE (M = 48.4 SD = 15.9); GSRS-IBS POST (M = 37.4 SD = 12.4); VSI PRE (M = 38.8 SD = 10.0) VSI POST (M = 25.9 SD = 10.1); PHQ12 PRE (M = 10.0 SD = 4.3); PHQ12 POST (M = 6.9 SD = 4.3); HADS anxiety PRE (M = 8.9 SD = 5.0) HADS anxiety POST (M = 5.7 SD = 3.3) HADS depression PRE (M = 5.6 SD = 3.2) HADS depression POST (M = 3.8 SD = 2.9) IBS-QOL PRE (M = 64.5 SD = 12.5) IBS-QOL POST (M = 72.3 SD = 10.0). The effects were maintained at follow-up, except for general anxiety and depression. Preliminary effects at 3-month follow-up were in the moderate to large range for main outcomes. CONCLUSION & INFERENCES: A 10-week group Ashtanga intervention was a feasible intervention for participants with IBS. Preliminary effects were promising and should be explored further in a randomized trial.

Quality of Life and Bidirectional Gut-Brain Interactions in Irritable Bowel Syndrome From Adolescence to Adulthood.

BACKGROUNDS AND AIMS: Reports on cross-sectional and longitudinal associations between health-related quality of life (HRQoL), psychological distress, and irritable bowel syndrome (IBS) in the adolescent and young adult general population are few. We aimed to describe cross-sectional associations between HRQoL and IBS in adolescence and young adulthood, and examine bidirectional gut-brain interactions in the transition from childhood to adulthood. METHODS: We included 3391 subjects from a prospective birth cohort study, with data on IBS at 16 years of age and 24 years of age. IBS was assessed using the pediatric Rome III (16 years of age) and the adult Rome IV (24 years of age) diagnostic questionnaires. HRQoL and psychological distress were assessed through EQ-5D. Sex-adjusted logistic regression models were used to examine associations between overall HRQoL/psychological distress at 16 years of age and new-onset IBS at 24 years of age (brain-gut) and between IBS at 16 years of age and new-onset psychological distress at 24 years of age (gut-brain). RESULTS: In subjects with vs without IBS at 16 and 24 years of age, overall HRQoL (EQ visual analog scale, EQ-5D index value) was lower, and it was more common reporting problems in 4 of 5 EQ-5D dimensions (all P < .05). EQ-5D index value at 16 years of age was inversely associated (odds ratio [OR], 0.1, 95% confidence interval [CI], 0.01-0.6), and psychological distress at 16 years of age was positively associated (OR, 1.6; 95% CI, 1.2-2.3), with new-onset IBS at 24 years of age. Having any abdominal pain-related disorder of gut-brain interaction at 16 years of age was associated with new-onset psychological distress at 24 years of age (OR, 1.7; 95% CI, 1.2-2.5). CONCLUSIONS: Adolescents and young adults with IBS in the general population have impaired HRQoL. Bidirectional gut-brain interactions are relevant for symptom generation in abdominal pain-related disorders of gut-brain interaction, and for HRQoL impairment and psychological distress in the transition from childhood to adulthood.

The impact of reduced worry on general functioning: A mediation analysis from a randomized trial.

Previous lab findings have indicated that excessive worry may impair cognitive performance and problem solving capabilities but it is unclear if excessive worry also leads to broader impairments in general functioning. We report a secondary process data analysis of a large randomized waitlist-controlled trial (N = 670) of a self-guided online psychological intervention for dysfunctional worry related to the Covid-19 pandemic. Specific aims were to investigate (1) if improvements in general functioning were mediated by reductions in worry related to Covid-19 during the acute intervention phase, and (2) if reduced worry related to Covid-19 during acute intervention phase had a positive long-term impact on general functioning up to 1 year after the end of the intervention. To address aim 1, we used a mediation analysis framework where outcome (general functioning measured with an adapted version of the Work and Social Adjustment Scale) and the hypothesized mediator (worry measured with an adapted version of the Generalised Anxiety Disorder 7-Item Scale) were administered weekly during the controlled phase of the trial of 3 weeks. To address aim 2, we investigated if reductions in worry during the 3-week treatment period predicted improved general functioning at 1- and 12 months after treatment completion. Results showed that improvements in general functioning at week 3 were mediated by reductions in worry during the first 2 weeks of treatment (indirect effect estimate -0.08; 95% CI -0.15, -0.02). A sensitivity analysis indicated that the mediation effects dropped significantly when the residual correlation values between the mediator and the outcome exceeded r = 0. A reversed causation model was not significant. Additionally, reductions in worry during treatment predicted subsequent improvements in general functioning at both 1- and 12-month follow-ups (p < .05, -.001). Altogether, these results provide further support of the importance of targeting worry as a way to improve functioning among the large population of individuals with high levels of worry.

Association between expectations and clinical outcomes in online v. face-to-face therapy - an individual participant data meta-analysis.

BACKGROUND: Online treatments are increasing in number and are currently available for a wide range of clinical problems. To date little is known about the role of treatment expectations and other placebo-like mechanisms in online settings compared to traditional face-to-face treatment. To address this knowledge gap, we analyzed individual participant data from randomized clinical trials that compared online and face-to-face psychological interventions. METHODS: MEDLINE (Ovid) and PsycINFO (Ovid) were last searched on 2 February 2021. Randomized clinical trials of therapist guided online v. face-to-face psychological interventions for psychiatric or somatic conditions using a randomized controlled design were included. Titles, abstracts, and full texts of studies were independently screened by multiple observers. The Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline was followed. Authors of the matching trials were contacted for individual participant data. Ratings from the Credibility and Expectancy Questionnaire and the primary outcome measure from each trial were used to estimate the association between expectation ratings and treatment outcomes in online v. face-to-face interventions, using a mixed-effects model. RESULTS: Of 7045 screened studies, 62 full-text articles were retrieved whereof six studies fulfilled the criteria and provided individual participant data (n = 491). Overall, CEQ ratings predicted clinical outcomes (ß = 0.27) at end of treatment with no moderating effect of treatment modality (online v. face-to-face). CONCLUSIONS: Online treatment appears to be equally susceptible to expectancy effects as face-to-face therapy. This furthers our understanding of the importance of placebo-like factors in online treatment and may aid the improvement of healthcare in online settings.

Effect of exposure-based vs traditional cognitive behavior therapy for fibromyalgia: a two-site single-blind randomized controlled trial.

ABSTRACT: Fibromyalgia is a debilitating pain condition for which treatment effects are typically modest. The most evaluated psychological treatment is traditional cognitive behavior therapy (T-CBT), but promising effects have recently been seen in exposure-based cognitive behavior therapy (Exp-CBT). We investigated whether Exp-CBT was superior to T-CBT in a randomized controlled trial. Self-referred participants with fibromyalgia (N = 274) were randomized (1:1) to 10 weeks of Exp-CBT or T-CBT. Treatments were delivered online and presented as "CBT for fibromyalgia." Participants were assessed at baseline, weekly during treatment, posttreatment, and at 6- and 12-month follow-up. Primary outcome was the difference in reduction in fibromyalgia severity as measured using the Fibromyalgia Impact Questionnaire (FIQ) over 11 assessment points from baseline to posttreatment, modelled within an intention-to-treat framework using linear mixed effects models fitted on multiple imputed data. Approximately 91% of weekly FIQ scores were collected over the main phase. There was no significant difference between Exp-CBT and T-CBT in the mean reduction of fibromyalgia severity from pretreatment to posttreatment (b = 1.3, 95% CI -3.0 to 5.7, P = 0.544, d = -0.10). Minimal clinically important improvement was seen 60% in Exp-CBT vs 59% in T-CBT. Effects were sustained up to 12 months posttreatment. This well-powered randomized trial indicated that Exp-CBT was not superior to T-CBT for fibromyalgia. Both treatments were associated with a marked reduction in fibromyalgia severity, and the online treatment format might be of high clinical utility. T-CBT can still be regarded a reference standard treatment that remains clinically relevant when compared to novel treatment approaches.

Brief scales for the measurement of target variables and processes of change in cognitive behaviour therapy for major depression, panic disorder and social anxiety disorder.

BACKGROUND: The measurement of process variables derived from cognitive behavioural theory can aid treatment development and support the clinician in following treatment progress. Self-report process measures are ideally brief, which reduces the burden on patients and facilitates the implementation of repeated measurements. AIMS: To develop 13 brief versions (3-6 items) of existing cognitive behavioural process scales for three common mental disorders: major depression, panic disorder, and social anxiety disorder. METHOD: Using data from a real-world teaching clinic offering internet-delivered cognitive behavior therapy (n=370), we drafted brief process scales and then validated these scales in later cohorts (n=293). RESULTS: In the validation data, change in the brief process scales significantly mediated change in the corresponding domain outcomes, with standardized coefficient point estimates in the range of -0.53 to -0.21. Correlations with the original process scales were substantial (r=.83-.96), internal consistency was mostly adequate (α=0.65-0.86), and change scores were moderate to large (|d|=0.51-1.18). For depression, the brief Behavioral Activation for Depression Scale-Activation subscale was especially promising. For panic disorder, the brief Agoraphobic Cognitions Questionnaire-Physical Consequences subscale was especially promising. For social anxiety disorder, the Social Cognitions Questionnaire, the Social Probability and Cost Questionnaire, and the Social Behavior Questionnaire-Avoidance and Impression Management subscales were all promising. CONCLUSIONS: Several brief process scales showed promise as measures of treatment processes in cognitive behaviour therapy. There is a need for replication and further evaluation using experimental designs, in other clinical settings, and preferably in larger samples.

Learning how to recover from stress: Results from an internet-based randomized controlled pilot trial.

•One of the first trials examining the efficacy of a brief preventive recovery training program in a sample of distressed employees.•Preliminary results suggest that employees across a wide range of professions could learn to recover, reduce stress, and improve quality-of-life.•This type of accessible and brief recovery intervention might shape the future of workplace stress prevention, however, more research is needed.

Guided LGBTQ-affirmative internet cognitive-behavioral therapy for sexual minority youth's mental health: A randomized controlled trial of a minority stress treatment approach.

OBJECTIVE: LGBTQ-affirmative cognitive-behavioral therapy (CBT) addresses the adverse impacts of minority stress. However, this treatment has rarely been tested in randomized controlled trials with LGBTQ youth and never using an asynchronous online platform for broad reach. This study examined the feasibility, acceptability, preliminary efficacy, and multi-level stigma moderators of LGBTQ-affirmative internet-based CBT (ICBT). METHOD: Participants were 120 LGBTQ youth (ages 16-25; 37.5% transgender or non-binary; 75.8% assigned female at birth; 49.2% non-Latino White) living across 38 U.S. states and reporting depression and/or anxiety symptoms. Participants were randomized to receive 10 sessions of LGBTQ-affirmative ICBT or only complete 10 weekly assessments of mental and behavioral health and minority stress; all completed measures of psychological distress, depression, anxiety, suicidal thoughts, alcohol use, and HIV-transmission-risk behavior at baseline and 4 and 8 months post-baseline; 20 LGBTQ-affirmative ICBT participants completed a qualitative interview regarding intervention acceptability. RESULTS: Participants randomized to LGBTQ-affirmative ICBT completed, on average, 6.08 (SD = 3.80) sessions. Participants reported that LGBTQ-affirmative ICBT was helpful and engaging and provided suggestions for enhancing engagement. Although most outcomes decreased over time, between-group comparisons were small and non-significant. LGBTQ-affirmative ICBT was more efficacious in reducing psychological distress than assessment-only for participants in counties high in anti-LGBTQ bias (b = -1.73, p = 0.001, 95% CI [-2.75, -0.70]). Session dosage also significantly predicted reduced depression and anxiety symptoms. CONCLUSIONS: LGBTQ-affirmative ICBT represents a feasible and acceptable treatment. Future research can identify more efficacious approaches and modalities for engaging LGBTQ youth, especially those living under stigmatizing conditions, who might benefit most.

Brief cognitive-behavioral treatment for avoidant/restrictive food intake disorder in the context of functional dyspepsia: Study protocol for a feasibility randomized controlled trial.

BACKGROUND: Avoidant/restrictive food intake disorder (ARFID) symptoms are common (up to 40%) among adults with functional dyspepsia (FD), a disorder of gut-brain interaction characterized by early satiation, post-prandial fullness, epigastric pain, and/or epigastric burning. Using an 8-session exposure-based cognitive-behavioral treatment (CBT) for adults with FD + ARFID compared to usual care (UC) alone, we aim to: (1) determine feasibility, (2) evaluate change in clinical outcomes in, and (3) explore possible mechanisms of action. METHODS: We will randomize adults with FD who meet criteria for ARFID with ≥5% weight loss (N = 50) in a 1:1 ratio to CBT (with continued UC) or to UC alone. A priori primary benchmarks will be: ≥75% eligible participants enroll; ≥75% participants complete assessments; ≥70% participants attend 6/8 sessions; ≥70% of sessions have all content delivered; ≥70% participants rate Client Satisfaction Questionnaire scores above scale midpoint. We will also examine the size of changes in FD symptom severity and related quality of life within and between groups, and explore possible mechanisms of action. CONCLUSIONS: Findings from this trial will inform next steps with treatment development or evaluation-either for further refinement or for next-step efficacy testing with a fully-powered clinical trial.

A Digital Self-help Intervention for Atopic Dermatitis: Analysis of Secondary Outcomes From a Feasibility Study.

BACKGROUND: Atopic dermatitis (AD) is a common inflammatory skin disease characterized by dry skin, eczematous lesions, and an often severe pruritus. The disease may have a negative effect on quality of life and is also associated with symptoms of anxiety and depression. Few individuals with AD receive any form of behavioral intervention. Behavioral interventions for AD are potentially efficacious but need to be constructed so that they are safe, credible, and user-friendly. We have previously reported on a feasibility study that demonstrated that a self-management version of a digital intervention based on cognitive behavioral therapy (CBT) for AD can potentially be effective in reducing AD symptoms. The aim of this secondary report was to further examine treatment feasibility and preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. OBJECTIVE: This is a secondary report on intervention credibility, usability, adverse events, and preliminary effects on secondary measures of a self-management digital intervention for atopic dermatitis. METHODS: In total, 21 adults with AD, recruited nationwide in Sweden, were assessed by telephone, and used the digital intervention for 8 weeks. Participants were also assessed directly afterward and 3 months after the end of the intervention. There was no therapist guidance. Feasibility indicators included intervention credibility, usability, and possible adverse effects. Other measures included preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. RESULTS: The intervention was regarded as credible and no serious adverse events were reported. System usability was, however, found to be below the predetermined cutoff for acceptable usability. Preliminary effects at 3-month follow-up were in the moderate to large range for dermatological quality of life (Cohen d=0.89, 95% CI 0.18-1.56), itching sensations (Cohen d=0.85, 95% CI 0.15-1.52), depressive symptoms (Cohen d=0.78, 95% CI 0.1-1.45), and perceived stress (Cohen d=0.75, 95% CI 0.01-1.36). CONCLUSIONS: This 8-week self-management digital CBT-based intervention was, together with telephone calls before and after, a feasible intervention for participants with AD. Preliminary effects were promising and should be explored further in a randomized controlled trial. Intervention usability was, however, rated below cutoff scores. Efforts should be made to improve written material to increase usability.

Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial.

Importance: Nonsuicidal self-injury is prevalent in adolescence and associated with adverse clinical outcomes. Effective interventions that are brief, transportable, and scalable are lacking. Objective: To test the hypotheses that an internet-delivered emotion regulation individual therapy for adolescents delivered adjunctive to treatment as usual is superior to treatment as usual only in reducing nonsuicidal self-injury and that improvements in emotion regulation mediate these treatment effects. Design, Setting, and Participants: This 3-site, single-masked, randomized superiority trial enrolled participants from November 20, 2017, to April 9, 2020. Eligible participants were aged between 13 and 17 years and met diagnostic criteria for nonsuicidal self-injury disorder; they were enrolled as a mixed cohort of consecutive patients and volunteers. Parents participated in parallel to their children. The primary end point was at 1 month after treatment. Participants were followed up at 3 months posttreatment. Data collection ended in January 2021. Interventions: Twelve weeks of therapist-guided, internet-delivered emotion regulation individual therapy delivered adjunctive to treatment as usual vs treatment as usual only. Main Outcomes and Measures: Primary outcome was the youth version of the Deliberate Self-harm Inventory, both self-reported by participants prior to treatment, once every week during treatment, and for 4 weeks posttreatment, and clinician-rated by masked assessors prior to treatment and at 1 and 3 months posttreatment. Results: A total of 166 adolescents (mean [SD] age, 15.0 [1.2] years; 154 [92.8%] female) were randomized to internet-delivered emotion regulation therapy plus treatment as usual (84 participants) or treatment as usual only (82 participants). The experimental intervention was superior to the control condition in reducing clinician-rated nonsuicidal self-injury (82% vs 47% reduction; incidence rate ratio, 0.34; 95% CI, 0.20-0.57) from pretreatment to 1-month posttreatment. These results were maintained at 3-month posttreatment. Improvements in emotion dysregulation mediated improvements in self-injury during treatment. Conclusions and Relevance: In this randomized clinical trial, a 12-week, therapist-guided, internet-delivered emotion regulation therapy delivered adjunctive to treatment as usual was efficacious in reducing self-injury, and mediation analysis supported the theorized role of emotion regulation as the mechanism of change in this treatment. This treatment may increase availability of evidence-based psychological treatments for adolescents with nonsuicidal self-injury. Trial Registration: ClinicalTrials.gov Identifier: NCT03353961.

Cognitive Behavioral Therapy Improves Quality of Life in Patients With Symptomatic Paroxysmal Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is often associated with troubling symptoms leading to impaired quality of life (QoL) and high health care use. Symptom preoccupation, that is, fear of cardiac-related symptoms and avoidance behavior, potentially contributes to disability in AF but is not targeted by current interventions. OBJECTIVES: We sought to evaluate the effect of online cognitive behavior therapy (AF-CBT) on QoL in patients with symptomatic paroxysmal AF. METHODS: Patients with symptomatic paroxysmal AF (n = 127) were randomly assigned to receive AF-CBT (n = 65) or standardized AF education (n = 62). Online AF-CBT lasted 10 weeks and was therapist guided. The main components were exposure to cardiac-related symptoms and reduction of AF-related avoidance behavior. Patients were evaluated at baseline, posttreatment, and at the 3-month follow-up. Primary outcome was AF-specific QoL as assessed by the Atrial Fibrillation Effect on Quality of Life summary score (range: 0-100) at the 3-month follow-up. Secondary outcomes included AF-specific health care consumption and AF burden assessed by 5-day continuous electrocardiogram recording. The AF-CBT group was followed for 12 months. RESULTS: AF-CBT led to large improvements in AF-specific QoL (Atrial Fibrillation Effect on Quality of Life summary score) by 15.0 points (95% CI: 10.1-19.8; P < 0.001). Furthermore, AF-CBT reduced health care consumption by 56% (95% CI: 22-90; P = 0.025). The AF burden remained unchanged. Results on self-assessed outcomes were sustained 12 months after treatment. CONCLUSIONS: In patients with symptomatic paroxysmal AF, online CBT led to large improvements in AF-specific QoL and reduced health care use. If these results are replicated, online CBT may constitute an important addition to AF management. (Internet-Delivered Cognitive Behavior Therapy for Atrial Fibrillation; NCT03378349).

Psychological treatments for irritable bowel syndrome: a comprehensive systematic review and meta-analysis.

A wide range of psychological treatments have been found to reduce the symptoms of irritable bowel syndrome (IBS) but their relative effects are unclear. In this systematic review and meta-analysis, we determined the effects of psychological treatments for IBS, including subtypes of cognitive behavior therapy, versus attention controls. We searched 11 databases (March 2022) for studies of psychological treatments for IBS, reported in journal articles, books, dissertations, and conference abstracts. The resulting database comprised 9 outcome domains from 118 studies published in 1983-2022. Using data from 62 studies and 6496 participants, we estimated the effect of treatment type on improvement in composite IBS severity using random-effects meta-regression. In comparison with the attention controls, there was a significant added effect of exposure therapy (g = 0.52, 95% CI = 0.17-0.88) and hypnotherapy (g = 0.36, 95% CI = 0.06-0.67) when controlling for the pre- to post-assessment duration. When additional potential confounders were included, exposure therapy but not hypnotherapy retained a significant added effect. Effects were also larger with a longer duration, individual treatment, questionnaire (non-diary) outcomes, and recruitment outside of routine care. Heterogeneity was substantial. Tentatively, exposure therapy appears to be a particularly promising treatment for IBS. More direct comparisons in randomized controlled trials are needed. OSF.io identifier: 5yh9a.