Self-guided Intervention Research Articles

A self-guided virtual reality solution for social anxiety: Results from a randomized controlled study

ObjectiveThe study examines the efficacy of a mobile application, oVRcome, which offers self-managed virtual reality exposure therapy combined with cognitive-behavioural techniques to treat social anxiety disorder. MethodsA randomized controlled trial (RCT) was conducted over six weeks with a waitlist delayed treatment group and follow-ups at 12 and 18 weeks. Participants were adults living in New Zealand with moderate to severe social anxiety disorder, as measured by the Liebowitz Social Anxiety Scale (LSAS). The primary focus was on the change in LSAS scores from baseline to the sixth week. All analyses utilized the intention-to-treat data. ResultsOut of 126 randomized participants, 81 completed the six-week follow-up. The retention rate at week 6 was 67.5%. The reduction in LSAS scores was significantly greater in the active group compared to the waitlist delayed treatment group (active group mean = −35.7 [SD = 24.0]; waitlist group: mean = − 2.2 [SD = 13.5]; p < 0.001), for an effect size of 1.8. ConclusionsThe study demonstrates that oVRcome can effectively reduce social anxiety symptoms, offering a viable self-guided treatment option. Trial registryClinicalTrials.gov ID NCT05576259.

Digital Mental Health Interventions for Adolescents in Low- and Middle-Income Countries: Scoping Review.

Digital mental health interventions (DMHIs) are increasingly recognized as potential solutions for adolescent mental health, particularly in low- and middle-income countries (LMICs). The United Nations' Sustainable Development Goals and universal health coverage are instrumental tools for achieving mental health for all. Within this context, understanding the design, evaluation, as well as the barriers and facilitators impacting adolescent engagement with mental health care through DMHIs is essential. This scoping review aims to provide insights into the current landscape of DMHIs for adolescents in LMICs. The Joanna Briggs Institute scoping review methodology was used, following the recommendations of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). Our search strategy incorporated 3 key concepts: population "adolescents," concept "digital mental health interventions," and context "LMICs." We adapted this strategy for various databases, including ACM Digital Library, APA PsycINFO, Cochrane Library, Google Scholar (including gray literature), IEEE Xplore, ProQuest, PubMed (NLM), ScienceDirect, Scopus, and Web of Science. The articles were screened against a specific eligibility criterion from January 2019 to March 2024. We analyzed 20 papers focusing on DMHIs for various mental health conditions among adolescents, such as depression, well-being, anxiety, stigma, self-harm, and suicide ideation. These interventions were delivered in diverse formats, including group delivery and self-guided interventions, with support from mental health professionals or involving lay professionals. The study designs and evaluation encompassed a range of methodologies, including randomized controlled trials, mixed methods studies, and feasibility studies. While there have been notable advancements in DMHIs for adolescents in LMICs, the research base remains limited. Significant knowledge gaps persist regarding the long-term clinical benefits, the maturity and readiness of LMIC digital infrastructure, cultural appropriateness, and cost-effectiveness across the heterogeneous LMIC settings. Addressing these gaps necessitates large-scale, co-designed, and culturally sensitive DMHI trials. Future work should address this.

Evaluating a mobile application based intervention for insomnia in college students: a preliminary study

Objective: This study examined the feasibility, acceptability, and efficacy of a self-guided, mobile application for Cognitive Behavioral Therapy for Insomnia (CBT-I Coach) in a sample of college students. Participants: Data was collected from 55 students, who mostly identified as women (82%) and white (84%) and reported at least moderate insomnia symptoms based on the Insomnia Severity Index. Methods: Participants were randomized to either an intervention condition (i.e., 4 wk of CBT-I Coach) or a wait-list condition and completed self-report measures biweekly across the 8-week study period. Results: Nearly 70% of participants found the app moderately to extremely effective. The intervention group experienced a larger reduction in insomnia symptoms from baseline to post-treatment compared to the control group (g = 0.88). Conclusions: These findings provide preliminary evidence that utilizing a self-guided mobile intervention for insomnia among college students is feasible and components of the app were perceived to be moderately to highly effective.

Feasibility and Acceptability of a Self-Guided Digital Family Skills Management Intervention for Children Newly Diagnosed With Type 1 Diabetes: Pilot Randomized Controlled Trial.

Family dynamics play an important role in determining the glycemic outcomes of type 1 diabetes (T1D) in children. The time interval immediately following T1D diagnosis is particularly stressful for families, and interventions to support families in adjusting their family practices to support adjustment to and management of T1D in the months following diagnosis may improve glycemic outcomes. Self-guided digital interventions offer a sustainable model for interventions to support caregivers in learning evidence-based family management skills for adjustment to and management of T1D. We hypothesized that a self-guided, web-based, family skills management program (addressing caregiver social support as well as family problem-solving, communication, and supportive behavior change strategies) initiated at the time of T1D diagnosis would improve glycemic outcomes in children with T1D. In this study, we report on the feasibility and acceptability of this program. We prospectively evaluated a sample of 37 children newly diagnosed with T1D recruited from a pediatric endocrinology clinic. Parent participants were asked to complete web-based modules addressing social support, family problem-solving, communication, and supportive behavior change strategies. Module completion was analyzed for percentage completion, patterns of completion, and differences in completion rates by coparenting status. Qualitative open-ended feedback was collected at the completion of each module. A total of 31 (84%) of the 37 participants initiated the web-based program. Of those 31 participants, 25 (81%) completed some content and 15 (48%) completed all 5 modules. Completion rates were higher when coparenting partners engaged in the intervention together (P=.04). Of the 18 participants given a choice about the spacing of content delivery, 15 (83%) chose to have all sessions delivered at once and 3 (17%) chose to space sessions out at 2-week intervals. Qualitative feedback supported the acceptability of the program for delivery soon after T1D diagnosis. Families reported on positive benefits, including requesting future access to the program and describing helpful changes in personal or family processes for managing T1D. In this study, we found that a self-guided digital family support intervention initiated at the time of a child's T1D diagnosis was largely feasible and acceptable. Overall, rates of participation and module completion were similar to or higher than other self-guided digital prevention interventions for mental and physical health outcomes. Self-guided digital programs addressing family management skills may help prevent challenges common with T1D management and can decrease cost, increase access, and add flexibility compared to traditional interventions. ClinicalTrials.gov NCT03720912; https://clinicaltrials.gov/study/NCT03720912.

Comparative efficacy of PsyPills and OCAT mobile psychological interventions in reducing depressive, anxiety and stress symptoms: A blinded randomized clinical trial

BackgroundDigital applications, such as in smartphone apps format, have shown high suggestive evidence for their efficacy in reducing general distress, but rigorous studies of their efficacy in symptom change and the mechanisms involved are still needed. MethodsIn the current multi-arm parallel-group randomized trial, participants aged 18–65 with smartphone access were recruited through social media. They were randomly assigned to two app interventions (PsyPills and OCAT) or an active placebo group (shamOCAT). The primary outcome was psychological distress measured up to one month. ResultsA total of 229 participants from diverse regional and demographic groups of the general population of Romania were randomly allocated into the three groups (PsyPills n = 80; OCAT n = 70; shamOCAT n = 79) and included in intention-to-treat analyses. Both the PsyPills (MD = −522; 95%CI = −10.00 to −0.44; d = 0.48) and OCAT (MD = −6.30; 95%CI = −11.39 to −1.21; d = 0.58) reduced significantly, with medium effect sizes, the psychological distress levels compared with the control group at follow-up. For the separate outcomes, only PsyPills showed significant medium reduction effects for anxiety symptoms (MD = −2.17; 95%CI = −3.83 to −0.50; d = −0.60), while OCAT showed reduction effects of small size for depression (MD = −1.50 (95%CI = −3.53 to 0.54, d = −0.34), that was however statistically nonsignificant. LimitationsWe registered high attrition and low adherence rates. Also, lower-than-planned effects might have been statistically underpowered to detect. ConclusionThe results support the high potential of both apps as scalable tools to provide low-intensity self-guided interventions for common psychological problems in the general population and expand opportunities for further research (e.g., confirm and capitulate on the differential effects).

Moderators of outcome in self-guided internet-delivered cognitive-behavior therapy for obsessive-compulsive disorder

Internet-delivered cognitive behavioural therapy (ICBT) is an effective treatment for obsessive-compulsive disorder (OCD). Currently there is limited research examining the predictors and moderators of outcome in ICBT for OCD. This study examined moderators of treatment outcome in a sample of 216 individuals who commenced a self-guided ICBT intervention for OCD (Mage = 34.00; SD = 12.57; 72.7% female). The results indicated that those with higher baseline OCD severity, depression severity, and neuroticism had less improvement at post-treatment and follow up (resulting in 40%, 24% and 12% higher symptom severity for every standard deviation increase on the measure at post-treatment and 33%, 17% and 20% higher symptoms at follow up respectively). However, participants with higher baseline treatment expectancy and readiness to reduce rituals and compulsions had better outcomes at post-treatment and three-month follow up (resulting in a 5% and 7% lower symptom severity for every standard deviation increase on the measure at post-treatment and 12% and 12% lower symptoms at follow up respectively). The results have important implications for who may respond best to self-guided ICBT.

The Effect of Online Music Therapy Interventions on Reducing Stress Levels in Small Hotel Managers: A Mixed-Methods Pilot Study

Abstract The rapidly changing business environment and increasing uncertainties due to the coronavirus disease 2019 pandemic since 2020 have led to heightened stress levels among managers. This study employed a mixed-method design to examine the effects of online music therapy interventions on reducing stress levels in small hotel managers. Thirteen managers participated in the online music therapy program, which consisted of six weekly music therapy sessions and self-guided music interventions for practice during the week. The music therapy interventions included music-assisted relaxation, improvisation, music listening with drawing, moving with music, song discussion, songwriting, and singing. The intake questionnaire collected participants’ demographic information and musical backgrounds. The Thai Perceived Stress Scale-10 (T-PSS-10) and Visual Analog Scale of Stress (VAS-S) were used to measure perceived stress levels. A paired t-test analysis compared the average participants’ perceived stress scores between pre and post-tests. Results demonstrated a significant reduction in perceived stress scores. Both the VAS-S for music therapy interventions and self-guided music interventions showed significant decreases after participation in each music therapy session and self-guided practice. In conclusion, online music therapy interventions can effectively reduce the perceived stress levels of managers facing uncertainty in small hotel businesses.

Systematic review and meta-analysis of standalone digital interventions for cognitive symptoms in people without dementia

Cognitive symptoms are prevalent across neuropsychiatric disorders, increase distress and impair quality of life. Self-guided digital interventions offer accessibility, scalability, and may overcome the research-to-practice treatment gap. Seventy-six trials with 5214 participants were identified. A random-effects meta-analysis investigated the effects of all digital self-guided interventions, compared to controls, at post-treatment. We found a small-to-moderate positive pooled effect on cognition (k = 71; g = −0.51, 95%CI −0.64 to −0.37; p < 0.00001) and mental health (k = 30; g = −0.41, 95%CI −0.60 to −0.22; p < 0.0001). Positive treatment effects on fatigue (k = 8; g = −0.27, 95%CI −0.53 to −0.02; p = 0.03) and quality of life (k = 22; g = −0.17, 95%CI −0.34 to −0.00; p = 0.04) were only marginally significant. No significant benefit was found for performance on activities of daily living. Results were independent of control groups, treatment duration, risk of bias and delivery format. Self-guided digital transdiagnostic interventions may benefit at least a subset of patients in the short run, yet their impact on non-cognitive outcomes remains uncertain.

Promoting sustained access to cognitive behavioral therapy for insomnia in Australia: a system-level implementation program.

Insomnia is a highly prevalent and debilitating disorder. Cognitive behavioral therapy for insomnia (CBTi) is the recommended 'fist line' treatment, but is accessed by a minority of people with insomnia. This paper describes a system-level implementation program to improve access to CBTi in Australia to inform CBTi implementation in other locations. From 2019 to 2023, we conducted a program of work to promote sustained change in access to CBTi in Australia. Three distinct phases included 1) Scoping and mapping barriers to CBTi access, 2) Analysis and synthesis of barriers and facilitators to devise change goals, and 3) Structured promotion and coordination of change. We used a system-level approach, knowledge brokerage, and co-design, and drew on qualitative, quantitative, and implementation science methods. We identified barriers to CBTi access from the perspectives of people with insomnia, primary care clinicians, and the health system. A stakeholder advisory committee was convened to co-design change goals, identify modifiable barriers, devise program logic and drive change strategies. We commenced a program to promote system-level change in CBTi access via; improved awareness and education of insomnia among primary care clinicians, self-guided interventions, and advocating to Government for additional CBTi funding mechanisms. This implementation program made significant progress toward improving access to CBTi in Australia. Ongoing work is required to continue this program, as long-term system-level change requires significant and sustained time, effort and resources from multiple stakeholders. This program may be used to inform CBTi implementation activities in other locations.

Pilot implementation of an evidence-based online cognitive behavioural therapy for perfectionism in university students: Lessons learnt.

Higher Education Institutes (HEIs) have been met with an unprecedented demand on their student counselling and wellbeing services in recent years with the impacts of COVID-19 and high rates of mental health concerns amongst student populations. Online mental health programs offer one solution by providing students with quick and easy access to effective therapeutic content. The Focused Minds Program is an evidence-based eight-module online self-guided cognitive behavioural intervention that targets the transdiagnostic risk factor of perfectionism and has been shown to decrease depression, anxiety, and disordered eating. The program was implemented at a UK university between 2021 and 2023. Recruitment occurred via departmental emails, academic staff, and the university's counselling staff and website. Participants were provided with access to the intervention for 6-weeks and completed weekly surveys of psychosocial measures. The trial's implementation was assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework: reach (uptake via the recruitment channels), effectiveness (outcomes on psychometric measures of mental wellbeing), adoption (staff and organisational support), implementation (intervention engagement and attrition), and maintenance (continued implementation across the trial period). Key barriers to successful implementation, as well as proposed solutions, are discussed to guide future online mental health interventions provided in HEIs.

Evaluation and Future Challenges in a Self-Guided Web-Based Intervention With and Without Chat Support for Depression and Anxiety Symptoms During the COVID-19 Pandemic: Randomized Controlled Trial.

The COVID-19 pandemic has had an impact on mental health worldwide. Low- and middle-income countries were largely affected by it. Mexico was one of the most affected countries. Extended periods of lockdowns, isolation, and social distancing, among other factors, highlighted the need to introduce web-based psychological interventions to the Mexican population. In this context, Mental Health COVID-19 emerged as a self-guided web-based intervention (SGWI) aimed at adults to improve mental health during the COVID-19 pandemic. This study aims to assess the efficacy of 2 modalities of a self-guided intervention (with and without chat support) in reducing depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation. In addition, it aimed to compare the moderating role of coping strategies, acceptance, and satisfaction in participants' symptom reduction. We hypothesize that the self-guided, chat-supported modality will show higher efficacy than the modality without chat support in achieving clinical change and better performance as a moderator of depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation, as well as an increase in participants' satisfaction and acceptability. A randomized controlled trial was conducted. Data were collected from May 2020 to June 2022. We performed intrasubject measures at 4 evaluation periods: pretest, posttest, and follow-up measurements at 3 and 6 months. Differences between intervention groups were assessed through the Mann-Whitney U test for continuous variables and the chi-square test for categorical variables. Changes due to intervention were analyzed using Wilcoxon W test. Moderated regression analysis was performed to test the hypothesized moderating role of coping strategies, usability, and opinion about treatment on clinical change. A total of 36 participants completed the intervention; of these, 5 (14%) were part of the SGWI group, and 31 (86%) were on the SGWI plus chat support (SGWI+C) group, which included a chat service with therapists. The perceived high complexity of the system for the SGWI group had a moderating effect associated with a lack of efficacy of the intervention regarding depression, but not when controlled for sociodemographic variables. A perception of lower helpfulness of the intervention was associated with poorer outcomes. Coping strategies did not show moderating effects. Enhancing the utility of web-based interventions for reducing clinical symptoms by incorporating a support chat to boost treatment adherence seemed to improve the perception of the intervention's usefulness. Web-based interventions face several challenges, such as eliminating complexities in platform use and increasing the users' perceived utility of the intervention, among other issues identified in the study. ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/study/NCT04468893?tab=results. RR2-10.2196/23117.

A hybrid type II effectiveness-implementation trial of a positive emotion regulation intervention among people living with HIV engaged in Ryan White Medical Case Management: protocol and design for the ORCHID study

BackgroundThe Ryan White Medical Case Management System, which serves more than half of people living with HIV (PLWH) in the USA, is an opportune setting for identifying and addressing depression among PLWH. A growing body of research suggests that interventions that promote positive emotion may lessen symptoms of depression and improve physical and psychological well-being among people experiencing a variety of health-related stress, including living with HIV. Research on how best to integrate standardized mental health screening and referral to evidence-based interventions in Ryan White Medical Case Management settings has the potential to improve the health and wellbeing of PLWH.MethodsThis mixed-methods study will enroll up to N = 300 Ryan White clients who screen positive for depressive symptoms in ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery), a web-based, self-guided positive emotion regulation intervention. The study will be conducted in 16 Ryan White Medical Case Management clinics in Chicago, IL. Following pre-implementation surveys and interviews with Medical Case Managers (MCMs) and Supervisors to develop an implementation facilitation strategy, we will conduct a hybrid type 2 implementation-effectiveness stepped wedge cluster randomized trial to iteratively improve the screening and referral process via interviews with MCMs in each wedge. We will test the effectiveness of ORCHID on depression and HIV care outcomes for PLWH enrolled in the program. RE-AIM is the implementation outcomes framework and the Consolidated Framework for Implementation Research is the implementation determinants framework.DiscussionStudy findings have the potential to improve mental health and substance use screening of Ryan White clients, decrease depression and improve HIV care outcomes, and inform the implementation of other evidence-based interventions in the Ryan White Medical Case Management System.Trial registrationClinicalTrials.gov NCT05123144. Trial registered 6/24/2021

Examining Self-Guided Interventions for Body-Focused Repetitive Behaviors in Dermatology: A Literature Review

Examining Self-Guided Interventions for Body-Focused Repetitive Behaviors in Dermatology: A Literature Review

A randomized controlled trial comparing brief online self-guided interventions for loneliness.

Loneliness is a global health issue, but current loneliness interventions are not scalable enough to reach many who might benefit from them. Brief online interventions could greatly expand access to evidence-based loneliness interventions. We conducted a preregistered three-armed trial (N = 908, ages 16-78) to compare three self-guided online interventions: a single-session intervention (SSI) for loneliness, a 3-week, three-session intervention for loneliness, and an active control supportive therapy SSI (https://ClinicalTrials.gov, ID: NCT05687162). Loneliness decreased between baseline and Week 8 across all conditions (b = -5.80; d = -0.55; 95% CI [-0.62, -0.47]; p < .01), but did not decrease significantly more in those assigned to either the loneliness SSI (b = -1.27; d = -0.12; 95% CI [-0.30, 0.06]; p = .20) or the 3-week intervention (b = -0.93; d = -0.09; 95% CI [-0.27, 0.09]; p = .34) than those assigned to the control SSI. Participants found all three interventions acceptable but rated both loneliness interventions as more acceptable than the control (p < .01). Far more participants completed the 10-min control SSI (86.6%) and 20-min loneliness SSI (69.4%) than the 60-min 3-week intervention (14.9%). An SSI for loneliness was not significantly less effective than a longer loneliness intervention and had a much higher completion rate. Yet, against our hypotheses, neither loneliness intervention reduced loneliness more than an active control SSI did. Future work should aim to design more effective SSIs for loneliness and identify populations for which SSIs might be most helpful. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Engagement challenges in digital mental health programs: hybrid approaches and user retention of an online self-knowledge journey in Brazil.

Digital mental health interventions (DMHIs) have surged in popularity over the last few years. However, adherence to self-guided interventions remains a major hurdle to overcome. The current study utilized a phased implementation design, incorporating diverse samples and contexts to delve into the engagement challenges faced by a recently launched online mental health platform in Brazil with self-evaluation forms. Employing an iterative mixed-methods approach, including focus groups, online surveys, and think-aloud protocols, the research aims to evaluate user satisfaction, identify barriers to adherence, and explore potential hybrid solutions. Engagement in the platform was evaluated by descriptive statistics of the number of instruments completed, and qualitative interviews that were interpreted thematically. In the fully self-guided mode, 2,145 individuals registered, but a substantial majority (88.9%) engaged with the platform for only 1 day, and merely 3.3% completed all activities. In another sample of 50 participants were given a choice between online-only or a hybrid experience with face-to-face meetings. 40% of individuals from the hybrid group completed all activities, compared to 8% in the online-only format. Time constraints emerged as a significant barrier to engagement, with suggested improvements including app development, periodic reminders, and meetings with healthcare professionals. While the study identified weaknesses in the number and length of instruments, personalized results stood out as a major strength. Overall, the findings indicate high satisfaction with the mental health platform but underscore the need for improvements, emphasizing the promise of personalized mental health information and acknowledging persistent barriers in a digital-only setting.

Accessibility and Utility of an Electronic Self-Guided Safety Plan for Adolescents

ABSTRACT Objective Suicidal thoughts and behaviors are a leading cause of death, injury, and hospitalization among adolescents. Few evidence-based interventions exist, and these tend to be inaccessible for most youth. Electronic safety plan interventions represent a new avenue to disseminate an evidence-based suicide prevention tool. However, it is not clear whether youth find electronic, self-guided safety plans helpful, nor whether they will use the resulting safety card when experiencing suicidal thoughts or urges. This study examines adolescents’ perceptions and use of an electronic, self-guided safety plan intervention. Method We recruited 322 adolescents with a past-year history of suicidal thoughts or behaviors, ages 13–17 (55.9% white and non-Hispanic; majority reporting diverse sexual orientations and genders) online via social media to participate in this two-part longitudinal study. At baseline, participants completed the electronic safety plan interventions and reported on key aspects of its usefulness and areas of improvement. Participants reported their use and perceptions of the plan one month later. Results Results suggested that adolescents understood, liked, and believed they would use a self-guided safety plan. One month later, about ⅓ of youth who experienced suicidal thoughts or urges used their safety card. Open-ended responses highlighted several features that adolescents enjoyed, including clarity, ease of use, and privacy. Participants also highlighted key areas for improvement, including formatting and language. Conclusion This study provides initial support for adolescent use of electronic self-guided safety plans. Next steps include updating this intervention based on youth feedback and testing the effectiveness of this tool using gold standard research methods.

Patient Self-Guided Interventions to Reduce Sedative Use and Improve Sleep

Direct-to-patient interventions enabling transitions from long-term benzodiazepine receptor agonist (BZRA) use to cognitive behavioral therapy for insomnia (CBTI) by older adults has the potential to reduce BZRA use and related harms while improving sleep outcomes without requiring prearranged clinician involvement. To compare 2 direct-to-patient behavior change interventions with treatment as usual (TAU) on BZRA use, sleep, and other health outcomes, and uptake of CBTI techniques. The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study was a 3-arm, pragmatic, open-label, minimum-contact, randomized clinical trial. The study began November 2020 and ended June 2022. Participants were randomly allocated to 1 of 3 groups, including 2 different mailed behavior change interventions or no intervention (TAU). Participants were from communities across the province of New Brunswick, Canada, and included adults 65 years and older living independently with long-term use of BZRAs and current or past insomnia. The Sleepwell package (YAWNS-1) consisted of a cover letter and 2 booklets ("How to Stop Sleeping Pills" and "How to Get Your Sleep Back"). The other package (YAWNS-2) included updated versions of the 2 booklets ("You May Be at Risk" and "How to Get a Good Night's Sleep Without Medication") used in the Eliminating Medications Through Patient Ownership of End Results (EMPOWER) study. BZRA use at 6 months was the primary measure. Secondary measures included CBTI use, sleep, insomnia, daytime sleepiness, safety, anxiety, frailty, and quality of life. A total of 1295 individuals expressed interest in the study, and 565 (43.6%) completed a baseline assessment. Participants had a mean (SD) age of 72.1 (5.7) years, a mean (SD) BZRA use duration of 11.4 (9.1) years, and 362 (64.1%) were female. Discontinuations and dose reductions of 25% or greater were highest with YAWNS-1 (50 of 191 [26.2%]; 39 of 191 [20.4%]; total, 46.6%) compared with YAWNS-2 (38 of 187 [20.3%]; 27 of 187 [14.4%]; total, 34.8%, P = .02) and TAU (14 of 187 [7.5%]; 24 of 187 [12.8%]; total, 20.3%, P < .001). YAWNS-1 also demonstrated better uptake of CBTI techniques and sleep outcomes compared with YAWNS-2 (new CBTI techniques: 3.1 vs 2.4; P =.03; sleep efficiency change: 4.1% vs -1.7%; P =.001) and reduced insomnia severity and daytime sleepiness compared with TAU (insomnia severity index change: -2.0 vs 0.3; P <.001; Epworth Sleepiness Scale change: -0.8 vs 0.3; P =.001). Results of the YAWNS NB randomized clinical trial show that, as a simple, scalable, direct-to-patient intervention, YAWNS-1 substantially reduced BZRA use and improved sleep outcomes. It could be implemented to transform insomnia care for older adults at the population level. ClinicalTrials.gov Identifier: NCT04406103.

A randomized trial testing digital medicine support models for mild-to-moderate alcohol use disorder

This paper reports the results of a hybrid effectiveness-implementation randomized trial that systematically varied levels of human oversight required to support the implementation of a digital medicine intervention for persons with mild-to-moderate alcohol use disorder (AUD). Participants were randomly assigned to three groups representing possible digital health support models within a health system: self-monitored use (SM; n = 185), peer-supported use (PS; n = 186), or a clinically integrated model CI; (n = 187). Across all three groups, the percentage of self-reported heavy drinking days dropped from 38.4% at baseline (95% CI [35.8%, 41%]) to 22.5% (19.5%, 25.5%) at 12 months. The clinically integrated group showed significant improvements in mental health and quality of life compared to the self-monitoring group (p = 0.011). However, higher attrition rates in the clinically integrated group warrant consideration in interpreting this result. Results suggest that making a self-guided digital intervention available to patients may be a viable option for health systems looking to promote alcohol risk reduction. This study was prospectively registered at clinicaltrials.gov on 7/03/2019 (NCT04011644).

Effects of a self-guided digital mental health self-help intervention for Syrian refugees in Egypt: A pragmatic randomized controlled trial

Background Digital mental health interventions for smartphones, such as the World Health Organization (WHO) Step-by-Step (SbS) program, are potentially scalable solutions to improve access to mental health and psychosocial support in refugee populations. Our study objective was to evaluate the effectiveness of SbS as self-guided intervention with optional message-based contact-on-demand (COD) support on reducing psychological distress, functional impairment, symptoms of posttraumatic stress disorder (PTSD), and self-identified problems in a sample of Syrian refugees residing in Egypt. Methods and findings We conducted a 2-arm pragmatic randomized controlled trial. A total of 538 Syrians residing in Egypt with elevated levels of psychological distress (Kessler Psychological Distress Scale; K10 &gt; 15) and reduced psychosocial functioning (WHODAS 2.0 &gt; 16) were randomized into SbS + CAU (N = 266) or CAU only (N = 272). Primary outcomes were psychological distress (Hopkins Symptom Checklist 25) and impaired functioning (WHO Disability Assessment Schedule 2.0) at 3-month follow-up. Secondary outcomes were symptoms of PTSD (PTSD Checklist for DSM-5 short form, PCL-5 short) and self-identified problems (Psychological Outcomes Profiles Scale, PSYCHLOPS). Intention-to-treat (ITT) analyses showed significant but small effects of condition on psychological distress (mean difference: −0.15; 95% CI: −0.28, −0.02; p = .02) and functioning (mean difference: −2.04; 95% CI: −3.87, −0.22; p = .02) at 3-month follow-up. There were no significant differences between groups on symptoms of PTSD and self-identified problems. Remission rates did not differ between conditions on any of the outcomes. COD was used by 9.4% of participants for a median of 1 contact per person. The main limitations are high intervention dropout and low utilization of COD support. Conclusions The trial provides a real-world implementation case, showing small positive effects of a digital, potentially scalable and self-guided mental health intervention for Syrian refugees in Egypt in reducing psychological distress and improving overall functioning. Further user-centered adaptations are required to improve adherence and effectiveness while maintaining scalability. Trial registration German Register for Clinical Studies DRKS00023505.

Acceptability and potential benefit of a self-compassion intervention for people living with amyotrophic lateral sclerosis: a mixed methods pilot study

Objective: This proof-of-concept study aimed to explore the acceptability and potential benefit of a self-guided online self-compassion intervention to aid resilient coping and reduce emotional distress among patients and caregivers living with ALS. Methods: A single-arm pilot study was conducted in 20 adults living with ALS either as a patient or as a caregiver. Acceptability was examined using questionnaires (n = 20) and semi-structured interviews (n = 9). Potential benefit was assessed as changes in self-compassion, self-criticism and emotional distress, determined using psychological questionnaires at 3 and 6 weeks. Questionnaires were analyzed using linear mixed-effects models and interview data using inductive thematic analysis. Results: Out of 20 participants who started the intervention, 16 completed the study (80%). The majority of study completers (12/16) were satisfied with the intervention, but the data suggest room for improvement in terms of personalization. Qualitative data revealed multiple psychological benefits of using the intervention, including self-kindness, emotional self-awareness and savoring. Although not statistically significant, quantitative data showed positive trends with increased self-compassion (mean difference: 2.07; 95% CI: −.5.76 − 1.63) and reduced self-criticism (mean difference: −2.62; 95% CI: −.1.97 − 7.23) and emotional distress (mean difference: −2.49; 95% CI: −.51 − 5.50) at week 6 compared to baseline. Conclusions: The findings suggest that a self-compassion intervention is acceptable to people living with ALS, but its beneficial effects and the mechanisms involved have yet to be established in larger and more diverse samples, using controlled designs.