Jmir Mental Health最新文献

{"title":"Does the Digital Therapeutic Alliance Exist? Integrative Review.","authors":"Amylie Malouin-Lachance, Julien Capolupo, Chloé Laplante, Alexandre Hudon","doi":"10.2196/69294","DOIUrl":"10.2196/69294","url":null,"abstract":"<p><strong>Background: </strong>Mental health disorders significantly impact global populations, prompting the rise of digital mental health interventions, such as artificial intelligence (AI)-powered chatbots, to address gaps in access to care. This review explores the potential for a \"digital therapeutic alliance (DTA),\" emphasizing empathy, engagement, and alignment with traditional therapeutic principles to enhance user outcomes.</p><p><strong>Objective: </strong>The primary objective of this review was to identify key concepts underlying the DTA in AI-driven psychotherapeutic interventions for mental health. The secondary objective was to propose an initial definition of the DTA based on these identified concepts.</p><p><strong>Methods: </strong>The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) for scoping reviews and Tavares de Souza's integrative review methodology were followed, encompassing systematic literature searches in Medline, Web of Science, PsycNet, and Google Scholar. Data from eligible studies were extracted and analyzed using Horvath et al's conceptual framework on a therapeutic alliance, focusing on goal alignment, task agreement, and the therapeutic bond, with quality assessed using the Newcastle-Ottawa Scale and Cochrane Risk of Bias Tool.</p><p><strong>Results: </strong>A total of 28 studies were identified from an initial pool of 1294 articles after excluding duplicates and ineligible studies. These studies informed the development of a conceptual framework for a DTA, encompassing key elements such as goal alignment, task agreement, therapeutic bond, user engagement, and the facilitators and barriers affecting therapeutic outcomes. The interventions primarily focused on AI-powered chatbots, digital psychotherapy, and other digital tools.</p><p><strong>Conclusions: </strong>The findings of this integrative review provide a foundational framework for the concept of a DTA and report its potential to replicate key therapeutic mechanisms such as empathy, trust, and collaboration in AI-driven psychotherapeutic tools. While the DTA shows promise in enhancing accessibility and engagement in mental health care, further research and innovation are needed to address challenges such as personalization, ethical concerns, and long-term impact.</p>","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e69294"},"PeriodicalIF":5.8,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11830484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of a Guided Chatbot Intervention for Young People in Jordan: Feasibility Randomized Controlled Trial.","authors":"Anne Marijn de Graaff, Rand Habashneh, Sarah Fanatseh, Dharani Keyan, Aemal Akhtar, Adnan Abualhaija, Muhannad Faroun, Ibrahim Said Aqel, Latefa Dardas, Chiara Servili, Mark van Ommeren, Richard Bryant, Kenneth Carswell","doi":"10.2196/63515","DOIUrl":"10.2196/63515","url":null,"abstract":"<p><strong>Background: </strong>Depression and anxiety are a leading cause of disability worldwide and often start during adolescence and young adulthood. The majority of young people live in low- and middle-income countries where there is a lack of mental health services. The World Health Organization (WHO) developed a guided, nonartificial intelligence chatbot intervention called Scalable Technology for Adolescents and youth to Reduce Stress (STARS) to reduce symptoms of depression and anxiety among young people affected by adversity.</p><p><strong>Objective: </strong>The objective of this study was to evaluate the feasibility of the STARS intervention and study procedures among young people in Jordan.</p><p><strong>Methods: </strong>A 2-arm, single-blind, feasibility randomized controlled trial was conducted among 60 young people aged 18 years to 21 years living in Jordan with self-reported elevated levels of psychological distress. Immediately after baseline, participants were randomized 1:1 into the STARS intervention or enhanced care as usual (ECAU). STARS consisted of 10 lessons in which participants interacted with a chatbot and learned several cognitive behavioral therapy strategies, with optional guidance by a trained e-helper through 5 weekly phone calls. ECAU consisted of a static web page providing basic psychoeducation. Online questionnaires were administered at baseline (week 0) and postassessment (week 8) to assess depression (Hopkins Symptom Checklist-25 [HSCL-25]), anxiety (HSCL-25), functional impairment (WHO Disability Assessment Schedule [WHODAS] 2.0), psychological well-being (WHO-Five Well-Being Index [WHO-5]), and agency (State Hope Scale). Process evaluation interviews with stakeholders were conducted after the postassessment.</p><p><strong>Results: </strong>Participants were recruited in December 2022 and January 2023. Of 700 screening website visits, 160 participants were eligible, and 60 participants (mean age 19.7, SD 1.16 years; 49/60, 82% female) continued to baseline and were randomized into STARS (n=30) or ECAU (n=30). Of those who received STARS, 37% (11/30) completed at least 8 chatbot lessons, and 13% (4/30) completed all 5 support calls. The research protocol functioned well in terms of balanced randomization, high retention at postassessment (48/60, 80%), and good psychometric properties of the online questionnaires. Process evaluation interviews with STARS participants, ECAU participants, e-helpers, and the clinical supervisor indicated the acceptability of the study procedures and the STARS and ECAU conditions and highlighted several aspects that could be improved, including the e-helper support and features of the STARS chatbot.</p><p><strong>Conclusions: </strong>This study demonstrated the feasibility and acceptability of the STARS intervention and research procedures. A fully powered, definitive randomized controlled trial will be conducted to evaluate the effectiveness of STARS.</p><p><strong>Trial reg","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e63515"},"PeriodicalIF":4.8,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11840361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143257036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Effectiveness of InsightApp for Anxiety, Valued Action, and Psychological Resilience: Longitudinal Randomized Controlled Trial.","authors":"Victoria Amo, Falk Lieder","doi":"10.2196/57201","DOIUrl":"10.2196/57201","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Anxiety disorders are among the most prevalent mental disorders, and stress plays a significant role in their development. Ecological momentary interventions (EMIs) hold great potential to help people manage stress and anxiety by training emotion regulation and coping skills in real-life settings. InsightApp is a gamified EMI and research tool that incorporates elements from evidence-based therapeutic approaches. It is designed to strengthen people's metacognitive skills for coping with challenging real-life situations and embracing anxiety and other emotions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This randomized controlled trial aims to examine the effectiveness of InsightApp in (1) improving individuals' metacognitive strategies for coping with stress and anxiety and (2) promoting value-congruent action. It also evaluates how long these effects are retained. This experiment advances our understanding of the role of metacognition in emotional and behavioral reactivity to stress.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a randomized controlled trial with 228 participants (completion rate: n=197, 86.4%; mean age 38, SD 11.50 years; age range 20-80 years; female: n=101, 52.6%; and White: n=175, 91.1%), who were randomly assigned to either the treatment or the active placebo control group. During the 1-week intervention phase, the treatment group engaged with InsightApp, while participants in the control group interacted with a placebo version of the app that delivered executive function training. We assessed the differences between the 2 groups in posttest and follow-up assessments of mental health and well-being while controlling for preexisting differences. Moreover, we used a multilevel model to analyze the longitudinal data, focusing on the within-participant causal effects of the intervention on emotional and behavioral reactivity to daily stressors. Specifically, we measured daily anxiety, struggle with anxiety, and value-congruent action.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The intervention delivered by InsightApp yielded mixed results. On one hand, we found no significant posttest scores on mental health and well-being measures directly after the intervention or 7 days later (all P&gt;.22). In contrast, when confronted with real-life stress, the treatment group experienced a 15% lower increase in anxiety (1-tailed t test, t&lt;sub&gt;197&lt;/sub&gt;=-2.4; P=.009) and a 12% lower increase in the struggle with anxiety (t&lt;sub&gt;197&lt;/sub&gt;=-1.87; P=.031) than the control group. Furthermore, individuals in the treatment group demonstrated a 7% higher tendency to align their actions with their values compared to the control group (t&lt;sub&gt;197&lt;/sub&gt;=3.23; P=.002). After the intervention period, InsightApp's positive effects on the struggle with anxiety in reaction to stress were sustained, and increased to an 18% lower reactivity to stress (t&lt;sub&gt;197&lt;/sub&gt;=-2.84; P=.002).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;As our study yielded mixed resul","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e57201"},"PeriodicalIF":4.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11836588/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Differentiation of Self-Concepts in the Physical and Virtual Worlds Using Euclidean Distance Analysis and Its Relationship With Digitalization and Mental Health Among Young People: Cross-Sectional Study.","authors":"Kai Tai Chan, Christy Lm Hui, Charlton Cheung, Yi Nam Suen, Stephanie Ming Yin Wong, Corine Sm Wong, Bosco Ph Kam, Eric Yu Hai Chen","doi":"10.2196/60747","DOIUrl":"10.2196/60747","url":null,"abstract":"<p><strong>Background: </strong>Increasing observation and evidence suggest that the process of digitalization could have profound impact to the development of human mind and self, with potential mental health consequences. Self-differentiation is important in human identity and self-concept formation, which is believed to be involved in the process of digitalization.</p><p><strong>Objective: </strong>This study aimed to investigate the relationship between digitalization and personal attributes in the actual selves in the physical and virtual worlds.</p><p><strong>Methods: </strong>A community cohort of 397 participants aged 15 to 24 years old was recruited consecutively over about 3 months. Assessment was conducted upon the indicators of digitalization (smartphone use time, leisure online time, and age of first smartphone ownership), smartphone addiction, 14 selected personal attributes in the actual selves in the physical and virtual worlds, psychiatric symptomatology and personality traits. Euclidean distance analysis between the personal attributes in the actual selves in the physical and virtual worlds for the similarities of the 2 selves was performed in the analysis.</p><p><strong>Results: </strong>The current primary findings are the negative correlations between the similarity of the personal attributes in the physical actual self and virtual actual self, and smartphone use time, smartphone addiction as well as anxiety symptomatology respectively (P<.05 to P<.01).</p><p><strong>Conclusions: </strong>The current findings provide empirical evidence for the importance of maintaining a congruent self across the physical and virtual worlds, regulating smartphone use time, preventing smartphone addiction, and safeguarding mental health.</p>","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e60747"},"PeriodicalIF":4.8,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11829177/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143071198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Testing the Feasibility, Acceptability, and Potential Efficacy of an Innovative Digital Mental Health Care Delivery Model Designed to Increase Access to Care: Open Trial of the Digital Clinic.","authors":"Natalia Macrynikola, Kelly Chen, Erlend Lane, Nic Nguyen, Jennifer Pinto, Shirley Yen, John Torous","doi":"10.2196/65222","DOIUrl":"10.2196/65222","url":null,"abstract":"<p><strong>Background: </strong>Mental health concerns have become increasingly prevalent; however, care remains inaccessible to many. While digital mental health interventions offer a promising solution, self-help and even coached apps have not fully addressed the challenge. There is now a growing interest in hybrid, or blended, care approaches that use apps as tools to augment, rather than to entirely guide, care. The Digital Clinic is one such model, designed to increase access to high-quality mental health services.</p><p><strong>Objective: </strong>To assess the feasibility, acceptability, and potential efficacy of the Digital Clinic model, this study aims to conduct a nonrandomized open trial with participants experiencing depression, anxiety, or both, at various levels of clinical severity.</p><p><strong>Methods: </strong>Clinicians were trained in conducting brief transdiagnostic evidence-based treatment augmented by a mental health app (mindLAMP); digital navigators were trained in supporting participants' app engagement and digital literacy while also sharing app data with both patients and clinicians. Feasibility and acceptability of this 8-week program were assessed against a range of benchmarks. Potential efficacy was assessed by calculating pre-post change in symptoms of depression (Patient Health Questionnaire-9; PHQ-9), anxiety (7-item Generalized Anxiety Disorder; GAD-7), and comorbid depression and anxiety (Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS), as well as rates of clinically meaningful improvement and remission. Secondary outcomes included change in functional impairment, self-efficacy in managing emotions, and flourishing.</p><p><strong>Results: </strong>Of the 258 enrolled participants, 215 (83.3%) completed the 8-week program. Most were White (n=151, 70.2%) and identified as cisgender women (n=136, 63.3%), with a mean age of 41 (SD 14) years. Feasibility and acceptability were good to excellent across a range of domains. The program demonstrated potential efficacy: the average PHQ-9 score was moderate to moderately severe at baseline (mean 13.39, SD 4.53) and decreased to subclinical (mean 7.79, SD 4.61) by the end of the intervention (t₁₂₆=12.50, P<.001, Cohen d=1.11). Similarly, the average GAD-7 score decreased from moderate at baseline (mean 12.93, SD 3.67) to subclinical (mean 7.35, SD 4.19) by the end of the intervention (t₁₁₃=13, P<.001, Cohen d=1.22). Participation in the program was also associated with high rates of clinically significant improvement and remission.</p><p><strong>Conclusions: </strong>Results suggest that the Digital Clinic model is feasible, acceptable, and potentially efficacious, warranting a future randomized controlled trial to establish the efficacy of this innovative model of care.</p>","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e65222"},"PeriodicalIF":4.8,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11822323/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Role of Tailored Timing and Frequency Prompts on the Efficacy of an Internet-Delivered Stress Recovery Intervention for Health Care Workers: Randomized Controlled Trial.","authors":"Auguste Nomeikaite, Odeta Gelezelyte, Maria Böttche, Gerhard Andersson, Evaldas Kazlauskas","doi":"10.2196/62782","DOIUrl":"10.2196/62782","url":null,"abstract":"<p><strong>Background: </strong>Prompts offer a promising strategy to promote client engagement in internet-delivered cognitive behavioral therapy (ICBT). However, if the prompts do not meet the needs of clients, they can potentially be more obtrusive rather than helpful.</p><p><strong>Objective: </strong>The aim of this study was to test if prompts tailored based on timing and frequency, aligned with preintervention goal setting, can increase usage and the efficacy of a therapist-supported ICBT stress recovery intervention for health care workers.</p><p><strong>Methods: </strong>The 2-arm randomized controlled trial included 87 health care workers (99% female, aged 19-68 years: mean 39.61, SD 11.49): 43 in the standard intervention group and 44 in the tailored prompts group. The primary outcome measure was the Recovery Experiences Questionnaire, and the secondary outcomes were the Perceived Stress Scale-4, the Patient Health Questionnaire-4, and the World Health Organization-5 Well-Being Index. The self-report data were collected before the intervention (September 2022), postintervention (October 2022), and 6-month follow-up (May 2023).</p><p><strong>Results: </strong>The results showed that tailored prompts, although appreciated by the majority (39/40, 98%), did not improve intervention usage indicators, such as the number of logins (t₈₅=-0.91; P=.36), modules opened (t_83.57=-1.47; P=.15), modules completed (t₈₅=-0.71; P=.48), exercises completed (t₈₅=-1.05; P=.30), or the time spent using the program (χ²₂=1.1; P=.57). Similarly, tailored prompts did not increase the effects of the intervention in terms of stress recovery skills (Cohen d ranging from 0.31 to 0.85), perceived stress (d=-0.08; -0.70), depression (d=-0.11; -0.38), anxiety (d=-0.32; -0.64), or psychological well-being (d=0.26; 0.46). In addition, the standard intervention group showed greater long-term stress recovery effects than the group using the internet-delivered intervention supplemented by tailored prompts (β=-0.24, P=.03).</p><p><strong>Conclusions: </strong>Although the study confirmed the efficacy of the program, the merits of tailored prompts in ICBT for stress recovery were not supported. Future research is needed to test the effects of the stress recovery intervention supplemented by goal setting and tailored prompts.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05553210; https://clinicaltrials.gov/study/NCT05553210.</p>","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e62782"},"PeriodicalIF":4.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11815303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143061123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Psychological and Physiological Insights Through Digital Phenotyping by Analyzing the Discrepancies Between Subjective Insomnia Severity and Activity-Based Objective Sleep Measures: Observational Cohort Study.","authors":"Ji Won Yeom, Hyungju Kim, Seung Pil Pack, Heon-Jeong Lee, Taesu Cheong, Chul-Hyun Cho","doi":"10.2196/67478","DOIUrl":"10.2196/67478","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Insomnia is a prevalent sleep disorder affecting millions worldwide, with significant impacts on daily functioning and quality of life. While traditionally assessed through subjective measures such as the Insomnia Severity Index (ISI), the advent of wearable technology has enabled continuous, objective sleep monitoring in natural environments. However, the relationship between subjective insomnia severity and objective sleep parameters remains unclear.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to (1) explore the relationship between subjective insomnia severity, as measured by ISI scores, and activity-based objective sleep parameters obtained through wearable devices; (2) determine whether subjective perceptions of insomnia align with objective measures of sleep; and (3) identify key psychological and physiological factors contributing to the severity of subjective insomnia complaints.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A total of 250 participants, including both individuals with and without insomnia aged 19-70 years, were recruited from March 2023 to November 2023. Participants were grouped based on ISI scores: no insomnia, mild, moderate, and severe insomnia. Data collection involved subjective assessments through self-reported questionnaires and objective measurements using wearable devices (Fitbit Inspire 3) that monitored sleep parameters, physical activity, and heart rate. The participants also used a smartphone app for ecological momentary assessment, recording daily alcohol consumption, caffeine intake, exercise, and stress. Statistical analyses were used to compare groups on subjective and objective measures.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Results indicated no significant differences in general sleep structure (eg, total sleep time, rapid eye movement sleep time, and light sleep time) among the insomnia groups (mild, moderate, and severe) as classified by ISI scores (all P&gt;.05). Interestingly, the no insomnia group had longer total awake times and lower sleep quality compared with the insomnia groups. Among the insomnia groups, no significant differences were observed regarding sleep structure (all P&gt;.05), suggesting similar sleep patterns regardless of subjective insomnia severity. There were significant differences among the insomnia groups in stress levels, dysfunctional beliefs about sleep, and symptoms of restless leg syndrome (all P≤.001), with higher severity associated with higher scores in these factors. Contrary to expectations, no significant differences were observed in caffeine intake (P=.42) and alcohol consumption (P=.07) between the groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The findings demonstrate a discrepancy between subjective perceptions of insomnia severity and activity-based objective sleep parameters, suggesting that factors beyond sleep duration and quality may contribute to subjective sleep complaints. Psychological factors, such as stress, dysfunctional sleep beliefs, and","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e67478"},"PeriodicalIF":4.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811666/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishment and Maintenance of a Digital Therapeutic Alliance in People Living With Negative Symptoms of Schizophrenia: Two Exploratory Single-Arm Studies.","authors":"Cassandra Snipes, Cornelia Dorner-Ciossek, Brendan D Hare, Olya Besedina, Tim Campellone, Mariya Petrova, Shaheen E Lakhan, Abhishek Pratap","doi":"10.2196/64959","DOIUrl":"10.2196/64959","url":null,"abstract":"<p><strong>Background: </strong>Evidence-based digital therapeutics represent a new treatment modality in mental health, potentially providing cost-efficient, accessible means of augmenting existing treatments for chronic mental illnesses. CT-155/BI 3972080 is a prescription digital therapeutic under development as an adjunct to standard of care treatments for patients 18 years of age and older with experiential negative symptoms (ENS) of schizophrenia. Individual components of CT-155/BI 3972080 are designed based on the underlying principles of face-to-face treatment. A positive therapeutic alliance between patients and health care providers is linked with improved clinical outcomes in mental health. Likewise, establishing a similar therapeutic alliance with a digital therapeutic (ie, digital working alliance [DWA]) may be important for engagement and treatment effectiveness of this modality.</p><p><strong>Objective: </strong>This study aimed to investigate the establishment and maintenance of a DWA between a beta version of CT-155/BI 3972080 (CT-155 beta) and adults with ENS of schizophrenia.</p><p><strong>Methods: </strong>Two multicenter, exploratory, single-arm studies (study 1: CT-155-C-001 and study 2: CT-155-C-002) enrolled adults with schizophrenia and ENS receiving stable antipsychotic medication (≥12 weeks). Participants had access to CT-155 beta and were presented with daily in-app activities during a 3-week orientation phase that included lessons designed to facilitate building of a DWA. In study 2, the 3-week orientation phase was followed by an abbreviated active 4-week phase. Digital literacy at baseline was evaluated using the Mobile Device Proficiency Questionnaire (MDPQ). The mobile Agnew Relationship Measure (mARM) was used to assess DWA establishment after 3 weeks in both studies, and after 7 weeks in study 2 to assess DWA maintenance. Participant safety, digital literacy, and correlations between negative symptom severity and DWA were assessed in both studies.</p><p><strong>Results: </strong>Of the enrolled participants, 94% (46/49) and 86% (43/50) completed studies 1 and 2, respectively. Most were male (study 1: 71%, 35/49; study 2: 80%, 40/50). The baseline digital literacy assessed through MDPQ score was comparable in both studies (study 1: mean 30.56, SD 8.06; study 2: mean 28.69, SD 8.31) indicating proficiency in mobile device use. After 3 weeks, mARM scores (study 1: mean 5.16, SD 0.8; study 2: mean 5.36, SD 1.06) indicated that a positive DWA was established in both studies. In study 2, the positive DWA established at week 3 was maintained at week 7 (mARM: mean 5.48, SD 0.97). There were no adverse events (AEs) in study 1, and 3 nonserious and nontreatment-related AEs in study 2.</p><p><strong>Conclusions: </strong>A positive DWA was established between participants and CT-155 beta within 3 weeks. The second 7-week study showed maintenance of the DWA to the end of the study. Results support the establishment and main","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e64959"},"PeriodicalIF":4.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811661/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of Digital Mental Health Interventions in the Workplace: Umbrella Review of Systematic Reviews.","authors":"Gillian Cameron, Maurice Mulvenna, Edel Ennis, Siobhan O'Neill, Raymond Bond, David Cameron, Alex Bunting","doi":"10.2196/67785","DOIUrl":"10.2196/67785","url":null,"abstract":"<p><strong>Background: </strong>There is potential for digital mental health interventions to provide affordable, efficient, and scalable support to individuals. Digital interventions, including cognitive behavioral therapy, stress management, and mindfulness programs, have shown promise when applied in workplace settings.</p><p><strong>Objective: </strong>The aim of this study is to conduct an umbrella review of systematic reviews in order to critically evaluate, synthesize, and summarize evidence of various digital mental health interventions available within a workplace setting.</p><p><strong>Methods: </strong>A systematic search was conducted to identify systematic reviews relating to digital interventions for the workplace, using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis). The review protocol was registered in the Open Science Framework. The following databases were searched: PubMed, Web of Science, MEDLINE, PsycINFO, and Cochrane Library. Data were extracted using a predefined extraction table. To assess the methodological quality of a study, the AMSTAR-2 tool was used to critically appraise systematic reviews of health care interventions.</p><p><strong>Results: </strong>The literature search resulted in 11,875 records, which was reduced to 14 full-text systematic literature reviews with the use of Covidence to remove duplicates and screen titles and abstracts. The 14 included reviews were published between 2014 and 2023, comprising 9 systematic reviews and 5 systematic reviews and meta-analyses. AMSTAR-2 was used to complete a quality assessment of the reviews, and the results were critically low for 7 literature reviews and low for the other 7 literature reviews. The most common types of digital intervention studied were cognitive behavioral therapy, mindfulness/meditation, and stress management followed by other self-help interventions. Effectiveness of digital interventions was found for many mental health symptoms and conditions in employee populations, such as stress, anxiety, depression, burnout, and psychological well-being. Factors such as type of technology, guidance, recruitment, tailoring, and demographics were found to impact effectiveness.</p><p><strong>Conclusions: </strong>This umbrella review aimed to critically evaluate, synthesize, and summarize evidence of various digital mental health interventions available within a workplace setting. Despite the low quality of the reviews, best practice guidelines can be derived from factors that impact the effectiveness of digital interventions in the workplace.</p><p><strong>Trial registration: </strong>OSF Registries osf.io/rc6ds; https://doi.org/10.17605/OSF.IO/RC6DS.</p>","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e67785"},"PeriodicalIF":5.8,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11806266/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrating Videoconferencing Therapist Guidance Into Stepped Care Internet-Delivered Cognitive Behavioral Therapy for Child and Adolescent Anxiety: Noninferiority Randomized Controlled Trial.","authors":"Sonja March, Susan H Spence, Larry Myers, Martelle Ford, Genevieve Smith, Caroline L Donovan","doi":"10.2196/57405","DOIUrl":"10.2196/57405","url":null,"abstract":"<p><strong>Background: </strong>Self-guided internet-delivered cognitive behavioral therapy (ICBT) achieves greater reach than ICBT delivered with therapist guidance, but demonstrates poorer engagement and fewer clinical benefits. Alternative models of care are required that promote engagement and are effective, accessible, and scalable.</p><p><strong>Objective: </strong>This randomized trial evaluated whether a stepped care approach to ICBT using therapist guidance via videoconferencing for the step-up component (ICBT-SC[VC]) is noninferior to ICBT with full therapist delivery by videoconferencing (ICBT-TG[VC]) for child and adolescent anxiety.</p><p><strong>Methods: </strong>Participants included 137 Australian children and adolescents aged 7 to 17 years (male: n=61, 44.5%) with a primary anxiety disorder who were recruited from participants presenting to the BRAVE Online website. This noninferiority randomized trial compared ICBT-SC[VC] to an ICBT-TG[VC] program, with assessments conducted at baseline, 12 weeks, and 9 months after treatment commencement. All ICBT-TG[VC] participants received therapist guidance (videoconferencing) after each session for all 10 sessions. All ICBT-SC[VC] participants completed the first 5 sessions online without therapist guidance. If they demonstrated response to treatment after 5 sessions (defined as reductions in anxiety symptoms to the nonclinical range), they continued sessions without therapist guidance. If they did not respond, participants were stepped up to receive supplemental therapist guidance (videoconferencing) for the remaining sessions. The measures included a clinical diagnostic interview (Anxiety Disorders Interview Schedule) with clinician-rated severity rating as the primary outcome and parent- and child-reported web-based surveys assessing anxiety and anxiety-related interference (secondary outcomes).</p><p><strong>Results: </strong>Although there were no substantial differences between the treatment conditions on primary and most secondary outcome measures, the noninferiority of ICBT-SC[VC] compared to ICBT-TG[VC] could not be determined. Significant clinical benefits were evident for participants in both treatments, although this was significantly higher for the ICBT-TG[VC] participants. Of the 89 participants (38 in ICBT-SC[VC] and 51 in ICBT-TG[VC]) who remained in the study, 26 (68%) in ICBT-SC[VC] and 45 (88%) in ICBT-TG[VC] were free of their primary anxiety diagnosis by the 9-month follow-up. For the intention-to-treat sample (N=137), 41% (27/66) ICBT-SC[VC], and 69% (49/71) ICBT-TG[VC] participants were free of their primary anxiety diagnosis. Therapy compliance was lower for the ICBT-SC[VC] participants (mean 7.39, SD 3.44 sessions) than for the ICBT-TG[VC] participants (mean 8.73, SD 3.08 sessions), although treatment satisfaction was moderate to high in both conditions.</p><p><strong>Conclusions: </strong>This study provided further support for the benefits of low-intensity ICBT f","PeriodicalId":48616,"journal":{"name":"Jmir Mental Health","volume":"12 ","pages":"e57405"},"PeriodicalIF":4.8,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799812/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143025193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}