Internet-Delivered Exposure and Response Prevention for Pediatric Tourette Syndrome: 12-Month Follow-Up of a Randomized Clinical Trial.

Importance: Behavior therapy is a recommended intervention for Tourette syndrome (TS) and chronic tic disorder (CTD), but availability is limited and long-term effects are uncertain. Objective: To investigate the long-term efficacy and cost-effectiveness of therapist-supported, internet-delivered exposure and response prevention (ERP) vs psychoeducation for youths with TS or CTD. Design, Setting, And Participants: This 12-month controlled follow-up of a parallel group, superiority randomized clinical trial was conducted at a research clinic in Stockholm, Sweden, with nationwide recruitment. In total, 221 participants aged 9 to 17 years with TS or CTD were enrolled between April 26, 2019, and April 9, 2021, of whom 208 (94%) provided 12-month follow-up data. Final follow-up data were collected on June 29, 2022. Outcome assessors were masked to treatment allocation throughout the study. Interventions: A total of 111 participants were originally randomly allocated to 10 weeks of therapist-supported, internet-delivered ERP and 110 participants to therapist-supported, internet-delivered psychoeducation. Main Outcomes And Measures: The primary outcome was within-group change in tic severity, measured by the Total Tic Severity Score of the Yale Global Tic Severity Scale (YGTSS-TTSS), from the 3-month follow-up to the 12-month follow-up. Treatment response was defined as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale. Analyses were intention-to-treat and followed the plan prespecified in the published study protocol. A health economic evaluation was performed from 3 perspectives: health care organization (including direct costs for treatment provided in the study), health care sector (additionally including health care resource use outside of the study), and societal (additionally including costs beyond health care [eg, parent's absenteeism from work]). Results: In total, 221 participants were recruited (mean [SD] age, 12.1 [2.3] years; 152 [69%] male). According to the YGTSS-TTSS, there were no statistically significant changes in tic severity from the 3-month to the 12-month follow-up in either group (ERP coefficient, -0.52 [95% CI, -1.26 to 0.21]; P = .16; psychoeducation coefficient, 0.00 [95% CI, -0.78 to 0.78]; P > .99). A secondary analysis including all assessment points (baseline to 12-month follow-up) showed no statistically significant between-group difference in tic severity from baseline to the 12-month follow-up (coefficient, -0.38 [95% CI, -1.11 to 0.35]; P = .30). Treatment response rates were similar in both groups (55% in ERP and 50% in psychoeducation; odds ratio, 1.25 [95% CI, 0.73-2.16]; P = .42) at the 12-month follow-up. The health economic evaluation showed that, from a health care sector perspective, ERP produced more quality-adjusted life years (0.01 [95% CI, -0.01 to 0.03]) and lower costs (adjusted mean difference -$84.48 [95% CI, -$440.20 to $977.60]) than psychoeducation at the 12-month follow-up. From the health care organization and societal perspectives, ERP produced more quality-adjusted life years at higher costs, with 65% to 78% probability of ERP being cost-effective compared with psychoeducation when using a willingness-to-pay threshold of US $79 000. Conclusions And Relevance: There were no statistically significant changes in tic severity from the 3-month through to the 12-month follow-up in either group. The ERP intervention was not superior to psychoeducation at any time point. While ERP was not superior to psychoeducation alone in reducing tic severity at the end of the follow-up period, ERP is recommended for clinical implementation due to its likely cost-effectiveness and support from previous literature. Trial Registration: ClinicalTrials.gov Identifier: NCT03916055.

Assessing the Feasibility and Preliminary Effects of a Web-Based Self-Management Program for Chronic Noncancer Pain: Mixed Methods Study.

BACKGROUND: In Canada, adults with chronic noncancer pain face a persistent insufficiency of publicly funded resources, with the gold standard multidisciplinary pain treatment facilities unable to meet the high clinical demand. Web-based self-management programs cost-effectively increase access to pain management and can improve several aspects of physical and emotional functioning. Aiming to meet the demand for accessible, fully automated resources for individuals with chronic noncancer pain, we developed a French web- and evidence-based self-management program, Agir pour moi (APM). This program includes pain education and strategies to reduce stress, practice mindfulness, apply pacing, engage in physical activity, identify and manage thinking traps, sleep better, adapt diet, and sustain behavior change. OBJECTIVE: This study aims to assess the APM self-management program's feasibility, acceptability, and preliminary effects in adults awaiting specialized services from a center of expertise in chronic pain management. METHODS: We conducted a mixed methods study with an explanatory sequential design, including a web-based 1-arm trial and qualitative semistructured interviews. We present the results from both phases through integrative tables called joint displays. RESULTS: Response rates were 70% (44/63) at postintervention and 56% (35/63) at 3-month follow-up among the 63 consenting participants who provided self-assessed information at baseline. In total, 46% (29/63) of the participants completed the program. We interviewed 24% (15/63) of the participants. The interview's first theme revolved around the overall acceptance, user-friendliness, and engaging nature of the program. The second theme emphasized the differentiation between microlevel and macrolevel engagements. The third theme delved into the diverse effects observed, potentially influenced by the macrolevel engagements. Participants highlighted the features that impacted their self-efficacy and the adoption of self-management strategies. We observed indications of improvement in self-efficacy, pain intensity, pain interference, depression, and catastrophizing. Interviewees described these and various other effects as potentially influenced by macrolevel engagement through behavioral change. CONCLUSIONS: These findings provided preliminary evidence that the APM self-management program and research methods are feasible. However, some participants expressed the need for at least phone reminders and minimal support from a professional available to answer questions over the first few weeks of the program to engage. Recruitment strategies of a future randomized controlled trial should focus on attracting a broader representation of individuals with chronic pain in terms of gender and ethnicity. TRIAL REGISTRATION: ClinicalTrials.gov NCT05319652; https://clinicaltrials.gov/study/NCT05319652.

Efficacy of the iJobs Web-Based Psychoeducational Intervention to Improve Job Search Behavior and Promote Mental Health Among Unemployed People: Protocol for a Waitlist Randomized Controlled Trial.

BACKGROUND: Unemployment affects millions of people worldwide and, beyond its economic impact, has severe implications for people's well-being and mental health. Different programs have been developed in response to this phenomenon, but to date, job-search interventions have proved to be most effective, especially the JOBS II program. The JOBS II program proved not only to be effective for re-employment but also has a positive impact on beneficiaries' mental health (ie, reduces anxiety or depression). However, by now, this evidence-based program has been delivered only on site in the various countries where it was implemented. In the digital era, web-based alternatives to such programs are highly needed because they have the advantages of scalability and cost-effectiveness. OBJECTIVE: In this context, we aim to investigate the efficacy of iJobs, the web-based adaptation of the JOBS II program, on job-search intensity and effort, the quality of job-search behaviors, and job-search self-efficacy. Further, 1 month after the intervention, we will also assess the employment status and the satisfaction with the job (if applicable). This study will also investigate the effect of iJobs on well-being and mental health (ie, anxiety and depression). METHODS: This study is a 2-arm randomized controlled trial. The 2 independent groups (intervention vs waiting list control group) will be crossed with 3 measurement times (ie, baseline, the postintervention time point, and 1-month follow-up). The design will be a 2 (intervention vs control) × 3 (baseline, the postintervention time point, and 1-month follow-up) factorial design. iJobs is a 2-week intervention consisting of 6 modules: an introductive module and 5 modules adapted from the original JOBS II program to the web-based setting and Romanian population. The web-based intervention also has a human component, as beneficiaries receive personalized written feedback after each module on the platform from a team of psychologists involved in the project. RESULTS: The enrollment of study participants started in June 2023 and is expected to end in May 2024. The data collection is expected to be completed by July 2024. The results are expected to be submitted for publication in the summer of 2024. CONCLUSIONS: This study is the first large-scale randomized controlled trial aiming to test the efficacy of a web-based adaptation of the JOBS II program. If our results support the efficacy of iJobs, they will offer the premise for it to become an evidence-based, accessible alternative for unemployed people in Romania and might be implemented in other countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT05962554; https://clinicaltrials.gov/study/NCT05962554. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55374.

Economic evaluation of Be a Mom, a web-based intervention to prevent postpartum depression in high-risk women alongside a randomized controlled trial.

BACKGROUND: Postpartum depression (PPD) poses significant challenges, affecting both mothers and children, with substantial societal and economic implications. Internet-based cognitive behavioral therapy interventions (iCBT) offer promise in addressing PPD, but their economic impact remains unexplored. This study aimed to evaluate the cost-utility of Be a Mom, a self-guided iCBT intervention, compared with a waiting-list control among postpartum women at high risk of PPD. METHODS: This economic evaluation was conducted alongside a 14-month randomized controlled trial adopting a societal perspective. Participants were randomized to Be a Mom (n = 542) or a waitlisted control group (n = 511). Self-report data on healthcare utilization, productivity losses, and quality-adjusted life years (QALYs) were collected at baseline, post-intervention, and 4 and 12 months post-intervention. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness acceptability curves were generated using nonparametric bootstrapping. Sensitivity analyses were conducted to assess result robustness. RESULTS: Over 14 months, Be a Mom generated a QALY gain of 0.0184 (0.0022, 0.0346), and cost savings of EUR 34.06 (-176.16, 108.04) compared to the control group. At a willingness to pay of EUR 20,000, Be a Mom had a 97.6 % probability of cost-effectiveness. LIMITATIONS: Results have limitations due to self-selected sample, potential recall bias in self-reporting, missing data, limited follow-up, and the use of a waiting-list control group. CONCLUSIONS: This study addresses a critical gap by providing evidence on the cost-utility of an iCBT intervention tailored for PPD prevention. Further research is essential to identify scalable and cost-effective interventions for reducing the burden of PPD.

Protocol for a pragmatic randomised controlled feasibility study of MS WorkSmart: an online intervention for Australians with MS who are employed.

INTRODUCTION: Multiple sclerosis (MS) causes a wide variety of symptoms. Loss of income due to sickness and early retirement comprise one-third of the total cost of MS in Australia. An intervention that maximises work productivity and keeps people with MS in the workforce for longer could provide a large societal cost saving and improve quality of life. The aim is to test the feasibility of delivering and evaluating a 10-week digitally delivered intervention called 'MS WorkSmart'. Findings will provide insights into participant profiles and address key methodological and procedural uncertainties (recruitment, retention, intervention adherence and engagement, and selection of primary outcome) in preparation for a subsequent definitive trial. METHODS AND ANALYSIS: A parallel-arm randomised controlled feasibility study, comparing those randomised to receive the MS WorkSmart package plus usual care (n=20) to those receiving usual care only (n=20). Australians with MS, aged 18-60 years, who are employed, and self-report work instability will be recruited from the Australian MS Longitudinal Study. Online surveys, at baseline and 1-month postintervention, will include MS-related work productivity loss and risk of job loss, MS work behaviour self-efficacy, health-related quality of life, fatigue severity, MS symptom impact on work, intention to retire due to MS, MS-related work difficulties, and awareness and readiness for change at work. Qualitative feedback will be obtained via a semistructured survey following the intervention (for participants) and via interviews (coaches). Analyses will be primarily descriptive and focus on the feasibility and acceptability of the intervention and study procedures. Progression criteria will guide decisions around whether to progress to a full trial. ETHICS AND DISSEMINATION: The study has been approved by the University of Tasmania Human Research Ethics Committee (H0024544). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and community presentations. TRIAL REGISTRATION NUMBER: ACTRN12622000826741.

Evaluating a novel online behavioural intervention to encourage cost-conscious strategies among US adults with chronic conditions who are enrolled in a high-deductible health plan: a proof-of-concept pilot study.

OBJECTIVES: Patients with chronic conditions enrolled in high-deductible health plans (HDHPs) face cost-related access barriers and high out-of-pocket spending. Our objectives were to develop a novel behavioural intervention to help HDHP enrollees with chronic conditions use cost-conscious strategies and evaluate the intervention's preliminary effectiveness, acceptability and feasibility. DESIGN: Prospective. SETTING: Online (USA). PARTICIPANTS: 36 US adults enrolled in an HDHP through their employer or an exchange with diabetes, hypertension, asthma, coronary artery disease and/or chronic obstructive pulmonary disease. 31/36 participants completed the study. INTERVENTION: We developed a 5-week intervention consisting of a website with educational modules on discussing costs with clinicians, saving for future healthcare costs, comparing healthcare prices and quality, preparing for appointments, following up after appointments and planning for future healthcare needs; and emails encouraging participants to access each module. OUTCOMES: We conducted a single-arm proof-of-concept pilot study of the intervention. Baseline and postintervention surveys measured primary outcomes of health insurance literacy and confidence in using cost-conscious strategies. 10 participants completed postintervention interviews. RESULTS: 31 (86%) participants completed a baseline and postintervention survey. Mean health insurance literacy scores (20-80 scale) improved from 56.5 to 67.1 (p<0.001). Mean confidence scores (0-10 scale) improved for talking to a healthcare provider about cost (6.1-7.6, p=0.0094), saving for healthcare (5.8-6.6, p=0.068), comparing prices (5.4-6.9, p=0.005) and comparing quality (6.1 to 7.6, p=0.0034). Participants found the website easy to use and helpful for learning about cost-conscious strategies on postintervention interviews. CONCLUSIONS: Our novel behavioural intervention was acceptable to HDHP enrollees with chronic conditions, feasible to deliver and associated with increased health insurance literacy and confidence in using cost-conscious strategies. This intervention should be tested in a definitive randomised controlled trial that is fully powered to evaluate its effects on cost-related access barriers, out-of-pocket spending and health outcomes in this growing patient population.

Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial.

BACKGROUND: Chronic musculoskeletal pain (CMP) is the most common, disabling, and costly of all pain conditions. While evidence exists for the efficacy of both duloxetine and web-based cognitive behavioral therapy (CBT) as monotherapy, there is a clear need to consider study of treatment components that may complement each other. In addition, given the reported association between patient's adherence and treatment outcomes, strategies are needed to enhance participant's motivation to adopt and maintain continued use of newly learned pain coping skills from CBT. METHODS: Two hundred eighty participants will be recruited from the primary care clinics of a large academic health care system in North Carolina. Participants with CMP will be randomized to one of three treatment arms: (1) combination treatment (duloxetine + web-based self-guided CBT) with phone-based motivational interviewing (MI), (2) combination treatment without phone-based MI, and (3) duloxetine monotherapy. Participants will be in the study for 24 weeks and will be assessed at baseline, week 13, and week 25. The primary outcome is the Brief Pain Inventory (BPI)-Global Pain Severity score, which combines BPI pain severity and BPI pain interference. Secondary measures include between-group comparisons in mean BPI pain severity and BPI pain interference scores. Data collection and outcome assessment will be blinded to treatment group assignment. DISCUSSION: This randomized controlled trial (RCT) will determine if combination treatment with duloxetine and web-based CBT is superior to duloxetine monotherapy for the management of CMP. Furthermore, this RCT will determine the effectiveness of phone-based motivational interviewing in promoting the continued practice of pain coping skills, thereby enhancing treatment outcomes. TRIAL REGISTRATION: NCT04395001 ClinicalTrials.gov. Registered on May 15, 2020.

A Web-Based Intervention Using "Five Ways to Wellbeing" to Promote Well-Being and Mental Health: Randomized Controlled Trial.

BACKGROUND: Compromised well-being and mental health problems pose a significant threat to individuals and societies worldwide. Resource-intensive psychological treatments alone cannot alleviate this burden. There is a need for low-cost, evidence-based interventions aimed at preventing illness and promoting well-being. Five activity domains appear to be linked with well-being promotion across populations: connecting with others, being active, taking notice, learning, and being generous/giving. The activities mentioned are part of the Five Ways to Wellbeing framework and the web-based intervention Five Ways to Wellbeing for All (5waysA). OBJECTIVE: This randomized controlled trial aims to test the effects of the 5waysA intervention, a web-based, low-cost, well-being-promoting measure targeting the general population. To date, the Five Ways to Wellbeing framework has not been tested in this specific format. The 5waysA intervention comprises 2 webinars and SMS text message reminders delivered over a 10-week period. METHODS: In 2021, a total of 969 study participants from various regions across Norway were openly recruited through a web page. They were then randomly assigned to either an intervention group or 1 of 2 waiting list control groups, namely, active or passive. Self-reported life satisfaction (Satisfaction With Life Scale [SWLS]), flourishing (Flourishing Scale [FS]), positive emotions, anxiety, and depression symptoms (Hopkins Symptom Checklist-8 [HSCL-8]) were assessed before the intervention, at 4 weeks into the intervention, and 1-2 weeks after the intervention (over 10 weeks). Data analysis was conducted using linear mixed (multilevel) models. RESULTS: After 10 weeks, 453 participants (171 in the intervention group and 282 in the waiting list control group) were assessed on outcome variables, with a dropout rate of 53.2% (516/969). Results revealed a significantly greater increase in the intervention group compared with the controls for SWLS (b=0.13, 95% CI 0.03-0.23; P=.001), FS (b=0.19, 95% CI 0.08-0.30; P=.001), positive emotions (b=0.43, 95% CI 0.27-0.60; P<.001), and these factors combined into a global well-being measure (b=0.28, CI 0.16-0.39; P<.001). Effect sizes (Cohen d) for the well-being outcomes ranged from 0.30 to 0.49. In addition, a significant decrease in anxiety and depressive symptoms was observed (b=-0.17, 95% CI -0.30 to -0.04; P=.001) with an effect size (Cohen d) of -0.20. CONCLUSIONS: The findings suggest that the web-based 5waysA intervention could serve as an effective approach for enhancing well-being and mental health within the general population. This study offers individuals, policy makers, and local stakeholders an accessible and potentially cost-effective well-being intervention that could be easily implemented. TRIAL REGISTRATION: ClinicalTrials.gov NCT04784871; https://clinicaltrials.gov/study/NCT04784871.

Internet-Based Cognitive Behavioural Treatments for Obsessive-Compulsive Disorder: A Systematic Review and Meta-Analysis.

Obsessive-compulsive disorder (OCD) is a common mental health condition characterized by distressing, intrusive thoughts (obsessions) and repetitive behaviours (compulsions) aimed at reducing anxiety. Internet-based cognitive behavioural therapy (ICBT) has emerged as an effective treatment modality for various mental health disorders. This meta-analysis evaluates the efficacy of guided self-help ICBT (GSH ICBT) and unguided self-help ICBT (SH ICBT) against active and passive control conditions in adults with OCD. A comprehensive systematic literature search yielded 12 randomized controlled trials (RCTs) comprising 15 comparison arms (N = 1416) that met the inclusion criteria. Results indicate that GSH ICBT significantly reduced OCD symptomatology posttreatment compared to active controls (g = 0.378, k = 9), with no significant effects maintained at follow-up (g = 0.153, k = 4). GSH ICBT was also found to be as effective as active CBT interventions in reducing comorbid anxiety and depression symptoms posttreatment (g = 0.278, k = 6) and at follow-up (g = 0.124, k = 4). However, improvements in quality of life were not significant posttreatment (g = 0.115, k = 4) nor at follow-up (g = 0.179, k = 3). Combined GSH and SH ICBT demonstrated large effects on reducing OCD symptoms (g = 0.754, k = 6), medium effects on comorbid symptoms (g = 0.547, k = 6) and small effects on quality of life (g = 0.227, k = 2) when compared to inactive controls. No significant differences were found between GSH and SH ICBT in all measured outcomes posttreatment (OCD: g = 0.098, k = 3; AD: g = 0.070, k = 3; QoL: g = -0.030, k = 1) and at follow-up (OCD: g = 0.265, k = 2; AD: g = 0.084, k = 2; QoL: g = 0.00, k = 1). Sample size was identified as a significant moderator of treatment effects. This paper further explores clinical significance, treatment adherence, therapist time investment and moderator influences of the ICBT. The limitations of the study and recommendations for future research are thoroughly discussed.

A Digital Behavioral Activation Intervention (JuNEX) for Pregnant Women With Subclinical Depression Symptoms: Explorative Co-Design Study.

BACKGROUND: Digital interventions are gaining increasing interest due to their structured nature, ready availability, and self-administered capabilities. Perinatal women have expressed a desire for such interventions. In this regard, behavioral activation interventions may be particularly suitable for digital administration. OBJECTIVE: This study aims to exploratorily investigate and compare the feasibility of the internet-based self-help guided versus unguided version of the Brief Behavioral Activation Treatment for Depression-Revised, an empirically supported in-person behavioral activation protocol, targeting pregnant women with subclinical depression symptoms. A user-centered design is used, whereby data are collected with the intent of evaluating how to adjust the intervention in line with pregnant women's needs. Usability and user engagement were evaluated. METHODS: A total of 11 Italian pregnant women with subclinical depressive symptoms based on the Patient Health Questionnaire-9 (scoring<15) participated in this study; of them, 6 (55%) women were randomly assigned to the guided group (age: mean 32.17, SD 4.36 years) and 5 (45%) to the unguided group (age: mean 31, SD 4.95 years). The Moodle platform was used to deliver the interventions in an e-learning format. It consisted of 6 core modules and 3 optional modules; the latter aimed at revising the content of the former. In the guided group, each woman had weekly chats with their assigned human guide to support them in the homework revisions. The intervention content included text, pictures, and videos. Semistructured interviews were conducted, and descriptive statistics were analyzed. RESULTS: Collectively, the data suggest that the guided intervention was better accepted than the unguided one. However, the high rates of dropout (at T6: guided group: 3/6, 50%; unguided: 4/5, 80%) suggest that a digital replica of Behavioral Activation Treatment for Depression-Revised may not be feasible in an e-learning format. The reduced usability of the platform used was reported, and homework was perceived as too time-consuming and effort-intensive. Moreover, the 6 core modules were deemed sufficient for the intervention's goals, suggesting that the 3 optional modules could be eliminated. Nevertheless, participants from both groups expressed satisfaction with the content and found it relevant to their pregnancy experiences. CONCLUSIONS: Overall, the findings have emphasized both the intervention's merits and shortcomings. Results highlight the unsuitability of replicating an in-person protocol digitally as well as of the use of nonprofessional tools for the implementation of self-help interventions, ultimately making the intervention not feasible. Pregnant women have nonetheless expressed a desire to receive psychological support and commented on the possibilities of digital psychosocial supports, particularly those that are app-based. The information collected and the issues identified here are important to guide the development and co-design of a more refined platform for the intervention deployment and to tailor the intervention's content to pregnant women's needs.

Effectiveness of a Web-Based Cognitive Behavioral Self-Help Intervention for Binge Eating Disorder: A Randomized Clinical Trial.

Importance: Binge eating disorder (BED) is one of the most frequent eating pathologies and imposes substantial emotional and physical distress, yet insufficient health care resources limit access to specialized treatment. Web-based self-help interventions emerge as a promising solution, offering more accessible care. Objective: To examine the effectiveness of a web-based cognitive behavioral self-help intervention for individuals with BED. Design, Setting, and Participants: This 2-arm, parallel-group randomized clinical trial conducted from January 15, 2021, to August 3, 2022, in Germany and other German-speaking countries enrolled patients aged 18 to 65 years who met the diagnostic criteria for BED (according to the Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition]). Data analysis occurred between January 27 and September 4, 2023, following our statistical analysis plan. Interventions: Participants were randomized to a web-based self-help intervention or a waiting-list control condition. Main Outcomes and Measures: The primary outcome was a change in objective binge eating episodes from baseline to after treatment. Secondary outcomes included global eating pathology, clinical impairment, work capacity, well-being, comorbid psychopathology, self-esteem, and emotion regulation. Results: A total of 1602 patients were screened, of whom 154 (mean [SD] age, 35.93 [10.59] years; 148 female [96.10%]) fulfilled the criteria for BED and were randomized (77 each to the intervention and control groups). The web-based intervention led to significant improvements in binge eating episodes (Cohen d, -0.79 [95% CI, -1.17 to -0.42]; P < .001), global eating psychopathology (Cohen d, -0.71 [95% CI, -1.07 to -0.35]; P < .001), weekly binge eating (Cohen d, -0.49 [95% CI, -0.74 to -0.24]; P < .001), clinical impairment (Cohen d, -0.75 [95% CI, -1.13 to -0.37]; P < .001), well-being (Cohen d, 0.38 [95% CI, 0.01 to 0.75]; P = .047), depression (Cohen d, -0.49 [95% CI, -0.86 to -0.12]; P = .01), anxiety (Cohen d, -0.37 [95% CI, -0.67 to -0.07]; P = .02), self-esteem (Cohen d, 0.36 [95% CI, 0.13 to 0.59]; P = .003), and emotion regulation (difficulties: Cohen d, -0.36 [95% CI, -0.65 to -0.07]; P = .01 and repertoire: Cohen d, 0.52 [95% CI, 0.19 to 0.84]; P = .003). Conclusion and Relevance: In this randomized clinical trial of a web-based self-help intervention for patients with BED, the findings confirmed its effectiveness in reducing binge eating episodes and improving various mental health outcomes, highlighting a scalable solution to bridge the treatment gap for this condition. Trial Registration: ClinicalTrials.gov Identifier: NCT04876183.

The change of working alliance and the association to treatment outcome in an internet-based therapy after pregnancy loss.

BACKGROUND: Working alliance is a prominent non-specific factor for treatment outcomes in face-to-face and internet-based interventions. The association between working alliance and therapy outcome appears to be time- and disorder-specific, but less is known about the change of working alliance during the intervention and the impact of working alliance in grief-specific interventions. The present study examines the association between the change of working alliance and treatment outcomes in an internet-based intervention for parents who experienced pregnancy loss. METHODS: 228 participants received a grief intervention based on cognitive behavioral therapy with asynchronous text-based therapist feedback. Prolonged grief and related symptoms of traumatic stress, depression, anxiety, and general psychopathology were assessed with validated instruments before and after the intervention. The change of working alliance was assessed using the short version of the Working Alliance Inventory at mid-treatment (session 4) and the end of the treatment (session 10). RESULTS: Data for N = 146 persons was analyzed. Working alliance in total and all subscales increased significantly from sessions 4 to 10. This change in working alliance correlated significantly with a reduction in prolonged grief. Changes in subscales of working alliance also correlated with symptoms of depression and general psychopathology. Regression analysis showed that a change in working alliance predicted a reduction in prolonged grief but did not predict improvements in other grief-related symptoms. CONCLUSION: The results examine the change of working alliance during an internet-based intervention and the association with treatment outcome. A small impact of change in working alliance on treatment outcome of prolonged grief was confirmed, but not on related symptoms. Further research is needed to assess moderators of the alliance-outcome association to improve internet-based interventions. TRIAL REGISTRATION: Not applicable.

Examining the Effectiveness of Interactive Webtoons for Premature Birth Prevention: Protocol for a Randomized Controlled Trial.

BACKGROUND: Premature birth poses significant health challenges globally, impacting infants, families, and society. Despite recognition of its contributing factors, efforts to reduce its incidence have seen limited success. A notable gap exists in the awareness among women of childbearing age (WCA) regarding both the risks of premature birth and the preventative measures they can take. Research suggests that enhancing health beliefs and self-management efficacy in WCA could foster preventive health behaviors. Interactive webtoons offer an innovative, cost-effective avenue for delivering engaging, accessible health education aimed at preventing premature birth. OBJECTIVE: This protocol describes a randomized controlled trial to assess the effectiveness and feasibility of a novel, self-guided, web-based intervention-Pregnancy Story I Didn't Know in Interactive Webtoon Series (PSIDK-iWebtoons)-designed to enhance self-management efficacy and promote behaviors preventing premature birth in WCA. METHODS: Using an explanatory sequential mixed methods design, this study first conducts a quantitative analysis followed by a qualitative inquiry to evaluate outcomes and feasibility. Participants are randomly assigned to 2 groups: one accessing the PSIDK-iWebtoons and the other receiving Pregnancy Story I Didn't Know in Text-Based Information (PSIDK-Texts) over 3 weeks. We measure primary efficacy through the self-management self-efficacy scale for premature birth prevention (PBP), alongside secondary outcomes including perceptions of susceptibility, severity, benefits, and barriers based on the health belief model for PBP and PBP intention. Additional participant-reported outcomes are assessed at baseline, the postintervention time point, and the 4-week follow-up. The feasibility of the intervention is assessed after the end of the 3-week intervention period. Outcome analysis uses repeated measures ANOVA for quantitative data, while qualitative data are explored through content analysis of interviews with 30 participants. RESULTS: The study received funding in June 2021 and institutional review board approval in October 2023. Both the PSIDK-iWebtoons and PSIDK-Texts interventions have been developed and pilot-tested from July to November 2023, with the main phase of quantitative data collection running from November 2023 to March 2024. Qualitative data collection commenced in February 2024 and will conclude in May 2024. Ongoing analyses include process evaluation and data interpretation. CONCLUSIONS: This trial will lay foundational insights into the nexus of interactive web-based interventions and the improvement of knowledge and practices related to PBP among WCA. By demonstrating the efficacy and feasibility of a web-based, interactive educational tool, this study will contribute essential evidence to the discourse on accessible and scientifically robust digital platforms. Positive findings will underscore the importance of such interventions in fostering preventive health behaviors, thereby supporting community-wide efforts to mitigate the risk of premature births through informed self-management practices. TRIAL REGISTRATION: Korea Disease Control and Prevention Agency (KDCA) KCT0008931; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25857. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58326.

A pilot feasibility and acceptability trial of an internet indicated prevention program for perfectionism to reduce eating disorder symptoms in adolescents.

PURPOSE: Perfectionism is a transdiagnostic risk factor for eating disorders. Treating perfectionism can reduce symptoms of eating disorders. No research has examined an indicated prevention trial using internet-based Cognitive-Behavioural Therapy for Perfectionism (ICBT-P) in adolescent girls at elevated risk for eating disorders. Our aim was to conduct a preliminary feasibility trial using a co-designed ICBT-P intervention. It was hypothesised that a higher proportion of participants in the ICBT-P condition would achieve reliable and clinically significant change on perfectionism, eating disorders, anxiety and depression, compared to waitlist control. METHODS: Twenty-one adolescent girls with elevated symptoms of eating disorders (M age = 16.14 years) were randomised to a 4-week online feasibility trial of a co-designed ICBT-P prevention program or waitlist control. Qualitative surveys were used to gain participant perspectives. RESULTS: The ICBT-P condition had a higher proportion of participants achieve reliable change and classified as recovered on perfectionism and symptoms of eating disorders and anxiety, compared to waitlist control. Qualitative findings indicated that 100% of participants found the program helpful. CONCLUSION: The results indicate ICBT-P is a feasible and acceptable program for adolescent girls with elevated eating disorder symptoms. Future research is required to examine outcomes in a randomised controlled trial. LEVEL OF EVIDENCE: Level III: Evidence obtained from well-designed cohort or case-control analytic studies. TRIAL REGISTRATION NUMBER: This trial was prospectively registered with Australian and New Zealand Clinical Trials Registry (ACTRN12620000951954P) on 23/09/2020.

Effects of a Planned Web-Based Educational Intervention Based on the Health Belief Model for Patients With Ischemic Stroke in Promoting Secondary Prevention During the COVID-19 Lockdown in China: Quasi-Experimental Study.

Background: Some common modified vascular risk factors remain poorly controlled among stroke survivors, and educational programs may help improve these conditions. Objective: This study aimed to evaluate the effect of a planned web-based educational intervention based on the health belief model (HBM) in promoting secondary prevention among patients with ischemic stroke. Methods: An evaluation-blinded quasi-experimental trial with a historical control group was conducted. Patients admitted from March to June 2020 were assigned to the historical control group, and patients admitted from July to October 2020 were assigned to the intervention group. The control group received routine health management. The intervention group received 6 additional sessions based on the HBM via Tencent Meeting, an audio and video conferencing application, within 3 months after discharge. Sessions were held every 2 weeks, with each session lasting approximately 40 minutes. These sessions were conducted in small groups, with about 8 to 10 people in each group. The primary outcomes were changes in blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), hemoglobin A1c (HbA1c), and the proportion of patients achieving the treatment target. The secondary outcomes were medication adherence, assessed with the Morisky Medicine Adherence Scale (MMAS), and disability, assessed with the modified Rankin scale. Results: In total, 315 patients experiencing their first-ever stroke were analyzed. More patients in the intervention group had controlled BP (41.9% vs 28.4%; adjusted odds ratio [aOR] 1.93; P=.01), LDL-C (83.1% vs 67.7%; aOR 2.66; P=.001), and HbA1c (91.9% vs 83.9%; aOR: 3.37; P=.04) levels as well as a significant postintervention decrease in the systolic BP (adjusted ß -3.94; P=.02), LDL-C (adjusted ß -0.21; P=.008), and HbA1c (adjusted ß -0.27; P<.001), compared with control groups. Significant between-group differences were observed in medication adherence (79.4% vs 63.2%; aOR 2.31; P=.002) but not in favorable functional outcomes. Conclusions: A web-based education program based on the HBM may be more effective than current methods used to educate patients having strokes on optimal vascular risk factors and medication adherence.

Internet-Based Versus Face-to-Face Cognitive-Behavioral Therapy for Social Anxiety Disorder: A Randomized Control Trial.

During the COVID-19 epidemic, face-to-face mental health services faced obstacles. Using Internet-based interventions was a good solution and had the potential to overcome these treatment barriers. However, there is no strong research evidence about the effectiveness of these methods for social anxiety disorder in different cultures and developing countries. Therefore, the present study aimed to investigate the effectiveness and application of Internet-based cognitive-behavioral therapy for social anxiety disorder in Iran. The current study was a pretest-posttest follow-up experimental design. Fifty-four adolescents with social anxiety disorder were selected from Lorestan province (Iran) by cluster sampling method and randomly assigned to three groups: face-to-face, internet-based, and wait-list control. At the beginning and end of the study and 3-month follow-up, three groups were interviewed and answered questionnaires related to the primary and secondary symptoms of social anxiety disorder. Two experimental groups were treated with the same therapeutic intervention during 10 weekly sessions. ANCOVA analysis showed that both forms of intervention effectively reduced social phobia, fear of negative evaluation and social interaction anxiety and increased emotion regulation. Also, a significant decrease in secondary outcomes, including physical symptoms, insomnia, social dysfunction, and depression symptoms, was observed in both groups. The treatment effects were stable during a 3-month follow-up. Our findings showed that although Internet-based cognitive-behavioral therapy for adolescents with social anxiety disorder can be effective, several clinical, cultural, and implementation weaknesses should be considered.

A Web-Based Intervention Based on Acceptance and Commitment Therapy for Family Caregivers of People With Dementia: Mixed Methods Feasibility Study.

BACKGROUND: Acceptance and commitment therapy (ACT), as an empirically based third-wave cognitive behavioral therapy, has shown promise in enhancing well-being and functioning across diverse populations. However, in the context of caregiving, the effect size of available ACT interventions remains at best moderate, sometimes accompanied by high dropout rates, highlighting the need for more effective and feasible intervention designs. OBJECTIVE: The objective of our study was to evaluate the feasibility and acceptability of a fully online ACT program designed for family caregivers of people with dementia. This study aimed to boost psychological flexibility and support caregivers, enabling them to realize and prioritize their own life values alongside their caregiving responsibilities. METHODS: A mixed methods feasibility study using an uncontrolled pretest-posttest design was conducted. This intervention included a 9-week web-based self-help program based on ACT incorporating collaborative goal setting and weekly web-based motivational coaching for family caregivers of people with dementia. This study involved 30 informal caregivers recruited through memory clinics and social media platforms in the Netherlands and received approval from the Medical Ethics Committee of the Maastricht University Medical Center+ (NL77389.068.21/metc21-029). RESULTS: A total of 24 caregivers completed the postintervention assessment, indicating a high adherence rate (24/29, 83%). Caregivers reported positive feedback regarding collaborative goal setting, but some found challenges in implementing new skills due to their own habitual responses or the unpredictable context of dementia caregiving. Personalizing the intervention based on individual value preferences was highlighted as beneficial. CONCLUSIONS: Compared to other web-based self-help ACT interventions for family caregivers, this intervention showed a high adherence and sufficient level of feasibility, which underscores the use of personalization in delivering web-based interventions. Moreover, the potential of this ACT-based intervention for family caregivers of people with dementia was demonstrated, suggesting that further research and a larger-scale controlled trial are warranted to validate its effectiveness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2022-070499.

A Web-Based and Mobile Intervention Program Using a Spaced Education Approach for Workplace Mental Health Literacy: Cluster Randomized Controlled Trial.

Background: Workplace mental health is an important global health concern. objectives: This unblinded, phase-III, wait-listed cluster randomized controlled trial aimed to examine the effectiveness of a mobile health (mHealth) psychoeducation program using a spaced education approach on mental health literacy (MHL) in the workplace. The main interest of this paper was the immediate and 3-month medium-term effect of the program on the MHL of workers. The purposely built mHealth platform was also evaluated as a health-related app. Methods: The mHealth platform was designed using the principle of spaced education as a psychoeducation intervention program, with various modules of web-based and mobile materials presented to the participant in a progressive manner. Short quizzes at the end of each module ensured adequate learning, and successful completion qualified the learner to progress to the next level. The trial recruited 456 employees of specific industries with high levels of work-related stress. Participants who were nested in different offices or units were allocated into the intervention and wait-listed control groups using a block randomization process, with the office or unit as the cluster. A separate sample of 70 individual raters were used for the evaluation of the mHealth platform. The Australian National MHL and Stigma Survey and the Mobile Apps Rating Scale were completed through a web-based self-reported survey to assess MHL and evaluate the app. The trial and follow-up data were analyzed by a generalized linear latent and mixed model with adjustments for the clustering effect of work sites and repeated measures. Results: Of the 456 participants in the trial, 236 (51.8%) responded to the follow-up survey. Most MHL outcomes obtained significant results immediately after the intervention and across time. After adjusting for the clustering effect, the postintervention weighted mean scores were significantly higher in the intervention group than the control group for correct recognition of a mental health problem, help seeking, and stigmatization by 0.2 (SE 0.1; P=.003), 0.9 (SE 0.2; P<.001), and 1.8 (SE 0.4; P<.001), respectively. After adjusting for the clustering effect, significant differences across time were found in help-seeking intention (P=.01), stigmatization (P<.001), and social distancing (P<.001). The evaluation of the mHealth program resulted in average scores of the 4 major domains ranging from 3.8 to 4.2, with engagement having the lowest score. Conclusions: The mHealth psychoeducation intervention program using this platform had immediate and 3-month medium-term effects of retaining and improving MHL. The platform was evaluated to have satisfactory performance in terms of functionality, aesthetics, information content, and utility in enhancing MHL. It is anticipated that ongoing development in digital health will provide great benefits in improving the mental health of the global population.

Effectiveness of a web-based group intervention for internet addiction in university students.

The phenomenon of Internet addiction has been systematically addressed with numerous studies highlighting its association with deficits in self-regulation. Despite the extensive literature elucidating the adverse effects of Internet addiction on university students, the availability of relevant interventions has remained constrained. The current study aimed at evaluating a web-based, group intervention, which aimed to prevent Internet addiction and enhance self-regulation. The sample consisted of 47 undergraduate and postgraduate university students (Ν = 47, Mage=21, SD = 3), who were divided into an intervention (n = 24) and a control group (n = 23). The participants were asked to complete a) the Internet Addiction Test (Young, 1998), and b) the Self-Regulation Questionnaire (Brown et al., 1999), prior to the commencement of the intervention, after its conclusion, and one and a half months after the intervention. The web-based intervention consisted of 6 sessions, over a two-week period. Results indicated an improvement of self-regulation and Internet addiction levels for the intervention group, compared to the control group. These results were maintained at the one and a half months follow-up. Implications for designing and implementing web-based group interventions for Internet addiction are discussed.