Tag: News Approved

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Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive Disorder

Conditions: Major Depressive Disorder; Post-Traumatic Stress Disorder (PTSD)

Interventions: Drug: Psilocybin; Behavioral: Structured Integrated Reframing Therapy (SIRT); Drug: Selective Serotonin Reuptake Inhibitor (SSRI)

Sponsors: Khyber Medical University Peshawar; Hayatabad Medical Complex; KMU Institute of Health Science, Islamabad

Recruiting
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VR-Based Behavioral Activation in Adults

Conditions: Depression – Major Depressive Disorder; Behavioral Activation; Virtual Reality Therapy; Behavioral Inhibition

Interventions: Device: Virtual Reality Behavioral Activation Software; Behavioral: Waitlist Control and Psychoeducation

Sponsors: KTO Karatay University

Completed
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A Web-Based Self-Management Intervention for Return-to-Work Among Persons With Common Mental Disorders on Sick Leave: Case Study of mWorks

Background: mWorks is a co-designed, web-based self-management intervention developed to empower persons with common mental disorders who are on sick leave during the return-to-work process. However, limited knowledge of how mWorks is delivered and engaged with in real-world settings constrains further development and implementation. In line with the Medical Research Council framework for complex intervention evaluation, such an approach is required to examine (1) contextual factors influencing implementation, (2) fidelity and variation in delivery, and (3) how service users and professionals experience and respond to the intervention. Objective: This study aimed to evaluate the process of implementing mWorks, specifically focusing on assessing the intervention’s delivery in relation to the context, implementation process, and mechanisms of impact. Methods: This single-case study was bounded by the delivery period of 10 weeks in a primary and specialist mental health service context. During this period, return-to-work professionals (n=2) and service users (n=6) collaborated to initiate mWorks usage. Both qualitative and quantitative methods were used to triangulate multiple data sources. Results: The pandemic and mental health problems posed contextual barriers, particularly during recruitment. However, perceptions of mWorks as a credible and relevant intervention facilitated its implementation. The delivery was performed according to plan, with minimal adaptations. All users adhered to the intervention, and dialogue meetings were highly valued. mWorks was used flexibly according to users’ needs, both during sick leave and at work. The potential impacts included a transformative process for users, fostering acceptance, self-esteem, self-compassion, and a sense of control. It also had the potential to prevent mental ill health, transform negatives into positives, facilitate disclosure of mental health, and support goal setting. The use of quantitative measures for empowerment, engagement, self-efficacy, depression stigma, and quality of life proved feasible and supported the assumptions and direction of results. Conclusions: The recruitment stage of the implementation program encountered significant contextual barriers. However, once the delivery stage began, the implementation of mWorks proved to be feasible. Despite the limited scope of this study, with its small number of participants, the triangulation of data suggests that both users and professionals benefited from mWorks.
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Development and Formative Evaluation of a Narrative-Based Serious Game for Pregnancy Education: Mixed Methods Study

Background: Serious games are increasingly used in professional health education and maternal health promotion. However, most pregnancy-related digital interventions target specific behaviors and do not provide a comprehensive, longitudinal simulation of the pregnancy journey that incorporates psychosocial and administrative aspects. Objective: This study aimed to develop and evaluate a narrative-based serious game that simulates the chronological course of pregnancy and to assess its perceived educational usefulness, accessibility, and user acceptance across multiple platforms. Methods: We developed a 9-chapter interactive serious game covering pregnancy recognition, partner communication, public health consultation, mid-pregnancy and late-pregnancy checkups, and home preparation for childbirth. The game was collaboratively created by a pediatrician, 6 medical students, and a student illustrator using a low-cost visual novel engine (TyranoBuilder). It was released in April 2025 on iOS, Android, and Steam. A voluntary, anonymous postgame survey was conducted between April 2025 and January 2026. Descriptive statistics were used to summarize survey responses and platform analytics. This study was approved by the Ethics Committee of Shinshu University Hospital. Results: A total of 65 users completed the postgame questionnaire. Most respondents were aged 10 to 19 years (38/65, 58.5%) and female (55/65, 84.6%). Nearly half of the participants (30/65, 46.2%) completed the game within 1 hour. Gameplay evaluation scores (5-point Likert scale; 3=neutral or appropriate) were balanced: game length (mean 3.37, SD 0.96), difficulty (mean 2.84, SD 0.85), and interactivity (mean 3.31, SD 1.10). Educational outcomes were rated highly (5-point Likert scale; higher=more favorable): reduced anxiety (mean 3.84, SD 0.96), perceived educational usefulness (mean 3.98, SD 1.02), perceived knowledge acquisition (mean 4.06, SD 1.06), story empathy (mean 3.80, SD 1.11), and overall satisfaction (mean 4.05, SD 1.04). Across all platforms, the game achieved 925 cumulative downloads. iOS and Android downloads were predominantly from Japan, whereas Steam downloads were geographically diverse. Of the 21 Steam reviews, 20 (95.2%) were positive. Conclusions: A serious pregnancy education game developed through a low-cost clinician-student collaborative model demonstrated high perceived educational usefulness, balanced gameplay characteristics, and broad user acceptance, including substantial engagement among teenagers and international users. Narrative-based serious games represent an accessible and scalable approach to maternal health education. Further research using more rigorous evaluation designs is warranted to assess long-term educational and behavioral impacts.
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Perspectives on Remote Monitoring via Smartphones and Wearables Among Individuals With Lived Experience or at Risk of Eating Disorders (“This Could Go Very, Very Wrong”): Qualitative Interview Study

Background: Remote measurement technology (RMT) is increasingly used in health research to collect real-world data relevant to clinical states (eg, sleep, activity, and stress). Concerns exist about the impact of remote tracking via personal devices and wearables on individuals with or at risk of eating disorders (EDs) by promoting a focus on exercise, diet, and appearance. There is a lack of research applying RMT to EDs. Objective: This study aimed to explore how smartphone- and wearable-based RMTs influence eating-, exercise-, and weight-related experiences among individuals with a history of or at risk of EDs and to identify perceived benefits, harms, and recommendations for their use in this population. Methods: In total, 14 semistructured interviews were conducted with former participants of Remote Assessment of Disease and Relapse: Major Depressive Disorder, a 2-year digital health study tracking depression outcomes via RMTs. Participants were included in this follow-up if they had disclosed a history of a comorbid ED or were within the at-risk age range (18-30 years) for EDs during Remote Assessment of Disease and Relapse: Major Depressive Disorder and displayed subclinical ED symptoms (Eating Disorder Diagnostic Scale). Interviews explored the impact of app engagement and wearables (Fitbits) on food, activity, and weight-related behaviors and attitudes. Template analysis was adopted to capture themes guided by the focus on ED-relevant domains. Results: In total, 6 themes captured participants’ experiences with RMTs across clinical status and presentation. Participants broadly appreciated the convenience and reflective potential, while some described emotional strain linked to constant self-tracking. Health data impacted participants’ eating and exercise habits through a dynamic process from awareness to cognition to action, fostering healthy routines or obsessive patterns, depending on emotional state, ED presentation, and recovery stage. Self-tracking appeared to mirror illness stage, supporting ED recovery among those with greater distance from illness, but risking reinforcement of compulsive patterns among those with residual or emerging symptoms. Participants’ recommendations for future studies in EDs stressed balancing autonomy with safeguards for vulnerable individuals. Conclusions: These exploratory findings, drawn from individuals with lived ED experience and young people at subclinical risk, suggest that RMT use was shaped by recovery stage and contextual factors, rather than being inherently beneficial or harmful. While findings should not be interpreted as evidence of RMT safety or acceptability in ED cohorts broadly, they raise important questions about ethical RMT design, including the selection of wearables, access to data, and researcher communication with participants.
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Very Low Uptake in Workplace Semen Analysis Research: Formative Web-Based Cross-Sectional Follow-Up Survey Distinguishing Employees With Self-Reported Unawareness From Aware Nonparticipants

Background: Very low uptake in workplace semen analysis research is difficult to interpret, particularly in employer-adjacent settings, where nonparticipation may reflect limited recruitment reach, limited understanding of the occupational rationale, low perceived relevance, or procedure-related concerns. Objective: This post hoc formative study described self-reported awareness of a parent workplace semen analysis study as an indicator of effective recruitment reach, reported reasons for nonparticipation under the implemented survey condition, and design issues for exposure-defined workplace reproductive health research. Methods: In April-May 2025, we conducted an anonymous web-based cross-sectional follow-up survey among male employees in Japan who had been eligible for, but had not completed, a parent workplace semen analysis study. The parent study invited approximately 2000 male employees from 3 companies between November 2024 and January 2025; 6 completed the protocol. The follow-up survey invited approximately 900 male employees from 1 company. Part 1 assessed awareness, reasons for nonparticipation, interest in male reproductive health information, and general openness to future related research. Optional Part 2 assessed age, knowledge, concerns, expected reactions, and willingness under simplified conditions. Responses were summarized descriptively using Wilson 95% CIs; no hypothesis testing was performed. Results: We analyzed 108 submitted questionnaires; 83 respondents completed Part 2. Overall, 74/108 (68.5%; 95% CI 59.3‐76.5) respondents reported no awareness of the parent study. Among unaware respondents, 68/74 (91.9%; 95% CI 83.4‐96.2) selected “did not know the study existed.” Among aware nonparticipants, the most frequent reasons were perceived irrelevance and resistance to collecting semen (each 9/34, 26.5%; 95% CI 14.6‐43.1), embarrassment or reluctance (8/34, 23.5%; 95% CI 12.4‐40), and hassle (7/34, 20.6%; 95% CI 10.3‐36.8). In Part 2, anxiety about unfavorable results was reported by 52/83 (62.7%; 95% CI 51.9‐72.3) respondents, concerns about collection location or privacy protection by 48/83 (57.8%; 95% CI 47.1‐67.9), and self-reported resistance by 42/83 (50.6%; 95% CI 40.1‐61.1). Under simplified conditions, 36/83 (43.4%; 95% CI 33.2‐54.1) respondents indicated willingness to undergo semen analysis. Conclusions: Very low uptake in this employer-adjacent semen analysis study was not interpretable as a single phenomenon. This post hoc formative process evaluation identified limited awareness, suggesting limited effective recruitment reach under the implemented procedures, and characterized the reason profile among aware nonparticipants, including low perceived relevance and semen collection–related concerns. Rather than identifying primary causal determinants of nonparticipation, the findings support a bounded recruitment-methodological interpretation and highlight recruitment-cascade components for prospective measurement: objective exposure to recruitment materials, information access, understanding of the occupational rationale, voluntary postinformation declination, privacy concerns, logistical burden, and specimen-return completion. Informed acceptability after occupational reproductive-hazard education should be evaluated in future designs that include such education and comprehension assessment.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/5074771fda02afb1286842c831d3f8f2" />

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Autism-Related Information on Websites and General-Purpose Artificial Intelligence Chatbots: Comparative, Bilingual Study

Background: Parents increasingly consult the internet, both websites and, more recently, artificial intelligence chatbots, for information on autism spectrum disorder (ASD). However, the comparative quality of these two source types, especially across languages, remains underexplored. Objective: This study aimed to assess the completeness and accuracy of ASD information delivered by websites and 5 popular artificial intelligence chatbots and determine whether performance differs between English and Romanian content. Methods: In a cross-sectional design, 25 English-language and 25 Romanian-language websites and the responses of ChatGPT, Gemini, Claude, Copilot, and DeepSeek were evaluated. Content was benchmarked against a 24-item checklist, yielding completeness and accuracy scores. Chatbots were tested in 2 scenarios: a single broad query (A) and 24 item-specific queries (B). Results: Websites achieved higher completeness in English than in Romanian (6.9 vs 5.1; =.007) and marginally higher accuracy (6.9 vs 6.1; =.045). In scenario A, chatbot completeness (English: 5.3 vs Romanian: 6.2; =.15) and accuracy (English: 6.0 vs Romanian: 5.6; =.32) did not show significant differences by language. In the single-query scenario, websites showed higher accuracy than chatbots in both English (6.9 vs 6.0; =.19) and Romanian (6.1 vs 5.6; =.53), with neither difference reaching statistical significance. Conversely, item-specific questioning favored chatbots, which yielded higher accuracy scores than websites in English (8.3 vs 6.9; =.053) and Romanian (8.0 vs 6.1; =.007). Accuracy scores improved significantly from the single-query to the item-specific scenario (English: 6.0 vs 8.3; =.002; Romanian: 5.6 vs 8.0; =.001). While an initial analysis suggested variation in performance between chatbots (repeated measures ANOVA; =.005), pairwise differences between individual models did not remain significant after adjustment for multiple testing. Conclusions: This exploratory study indicates that the quality of online ASD information varies by language and source context. English-language websites are more complete than Romanian-language websites. Among chatbots, targeted questioning yields more accurate answers than single broad queries in both languages. The findings should be interpreted cautiously due to the temporal gap between website and chatbot data collection.
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AI Agents Are Coming: 5-Stage Taxonomy of Language-Based AI Systems for Psychiatry, Psychotherapy, and Counseling

The rapid evolution of large language models has accelerated the development of agentic artificial intelligence (AI) systems capable of pursuing autonomous goals, creating an urgent need for structural frameworks in psychiatry and psychotherapy. While existing classifications often draw parallels to autonomous driving, this paper argues that the mental health domain requires a distinct, domain-specific theoretical foundation, as the 2 domains differ fundamentally in their semantic, ideographic, and epistemological demands. Furthermore, they differ in their end goals, for which we introduce terms such as agentic guidance capability. To guide clinicians and researchers through these developments, we propose a 5-stage taxonomy for language-based AI systems that differentiates technical functionality from clinical effectiveness. The taxonomy progresses from level 1 (knowledge level), in which systems perform static benchmark tasks, to level 2 (elementary level), characterized by dynamic engagement in specific therapeutic microskills. At level 3 (integration level), systems achieve consistency across and within modules, as well as basic case-level conceptualization suitable for blended therapy under human oversight. Level 4 (saturation level) describes therapist-in-the-loop systems capable of autonomous functioning with minimal supervision, whereas level 5 (mastery level) represents AI systems that are technically capable of performing autonomous therapy. By distinguishing technical functionality from clinical effectiveness, we conclude that level 4 or level 5 performance does not automatically translate into full treatment effectiveness, even if high treatment fidelity can be achieved. We conclude by emphasizing the need to shift benchmarking from static knowledge tests to dynamic evaluations of therapeutic capabilities in order to safely navigate the transition toward autonomous care.
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Attention-deficit/hyperactivity disorder and chronic pain: a scoping review of epidemiology, clinical phenotypes, mechanisms, and treatment

IntroductionEmerging evidence suggests a potential association between attention-deficit/hyperactivity disorder (ADHD) and chronic pain; however, extant findings are dispersed across disciplines and have not yet been comprehensively synthesized. This scoping review aimed to systematically map the epidemiological evidence, clinical phenotypes, proposed neurobiological mechanisms, and reported therapeutic interventions related to comorbid ADHD and chronic pain.MethodsA comprehensive literature search was conducted in PubMed, PsycINFO, and the Cochrane Library from database inception to December 28, 2025. Human studies examining the association between ADHD (diagnosed or symptom-defined) and chronic or recurrent pain were also included. Fifty studies met the eligibility criteria, including observational studies (cross-sectional and longitudinal), case reports and series, and one interventional study.ResultsEpidemiological studies have consistently reported significant associations between ADHD symptoms or diagnoses and chronic pain in both the general population and clinical samples. Higher ADHD symptom burden was associated with greater pain severity and pain-related functional impairment. Comorbidity was observed not only in widespread pain syndromes, such as fibromyalgia, but also in site-specific conditions, including chronic low back pain, orofacial pain, and migraine. Proposed mechanisms involve dopaminergic and noradrenergic dysfunction affecting motor regulation, sensory processing, and descending pain modulation systems. Several case-based reports have described improvements in pain outcomes after ADHD-targeted pharmacotherapy. However, controlled trials remain scarce.DiscussionCurrent evidence suggests that ADHD traits may be relevant in a subset of individuals with chronic pain, particularly those with treatment-resistant presentations. Although causality and treatment efficacy remain unconfirmed, consideration of neurodevelopmental characteristics may enhance clinical assessments and inform future research on individualized mechanism-based treatment strategies.