Direct and indirect associations of hypochondriasis with suicidality in psychiatric outpatients: mediating roles of anxiety and depression
Preoperative anxiety and depression symptoms are associated with poorer clinical outcomes following corrective surgery for adult equinocavovarus foot
Effectiveness of Behavioral Activation Group Therapy for Patients With Depression at the Community in Thanh Hoa
Interventions: Behavioral: Behaviral activation group therapy
Sponsors: Hanoi Medical University
Completed
Symptoms of Anxiety and/or Depression and SDM in Older Patients With CLTI
Sponsors: Guy’s and St Thomas’ NHS Foundation Trust; University Hospitals, Leicester
Not yet recruiting
Efficacy and Safety of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression
Interventions: Drug: antidepressant therapy; Device: Active rTMS Theta Burst Stimulation; Device: Sham Stimulation
Sponsors: Jung-Sun Lee; Korea Health Industry Development Institute; Seoul National University Hospital; Nowon Eulji Medical Center, Eulji University; Seoul St. Mary’s Hospital, The Catholic University
Not yet recruiting
Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression
Interventions: Device: Personalized iTBS; Device: Non-Personalized iTBS; Device: Sham iTBS
Sponsors: Stanford University; National Institute of Mental Health (NIMH)
Not yet recruiting
User Experience and Early Clinical Outcomes of a Mental Wellness Chatbot for Depression and Anxiety: Pilot Evaluation Mixed Methods Study
Background: Artificial intelligence–powered conversational agents (ie, chatbots) are increasingly popular outlets for users seeking psychological support, yet little is known about how users experience early-stage prototypes or which therapeutic processes contribute to clinical improvement. A transparent evaluation of emerging chatbot prototypes is needed to clarify if, how, and why artificial intelligence companions work and to guide their continued development. Objective: This mixed methods pilot study evaluated user experience, acceptability, and preliminary clinical signals for an early-stage mental wellness chatbot. We also examined whether baseline symptom severity moderated clinical improvement. Methods: Three sequential cohorts (n=125) completed a 2-week, incentivized chatbot exposure (approximately 60 min per week). Participants provided first-impression ratings, qualitative feedback, and pre–post assessments of depressive symptoms (PHQ-8 [Patient Health Questionnaire-8]), anxiety symptoms (GAD-7 [Generalized Anxiety Disorder-7]), psychological distress, well-being, and loneliness. Statistical models estimated symptom change and tested interactions with baseline symptom severity. Mixed methods analysis integrated quantitative outcomes with large language model–assisted qualitative content analysis of open-ended responses. Results: Participants described the chatbot as accessible, easy to use, and emotionally validating, while citing limitations in personalization and conversational depth. Qualitative responses consistently highlighted early therapeutic processes such as emotional validation, goal setting, and perceived attunement. Regression models showed significant pre–post reductions in depressive (Hedges =–0.32) and anxiety (=–0.32) symptoms, alongside modest improvements in distress and well-being. Baseline severity moderated improvement, with marginal effects indicating larger predicted reductions at higher PHQ-8 and GAD-7 baseline scores (eg, PHQ-8=15: =–0.84; GAD-7=15: =–0.62). Conclusions: This pilot provides a comprehensive view of early chatbot development and suggests promising user experiences and preliminary symptom improvements under structured pilot conditions. By integrating experiential and exploratory clinical data, the study identifies candidate process targets to inform ongoing refinement. Findings support continued development and demonstrate procedural feasibility for progression to larger, longer-term trials evaluating engagement and clinical outcomes under more naturalistic conditions.
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Development of Virtual Mental Health Stepped Care Service for a Heart Failure Remote Management Program: Qualitative Descriptive Study
Background: Depression is highly prevalent yet undertreated among people living with heart failure, indicating barriers to mental health services. Although various digital mental health interventions have been developed to detect, treat, and manage depression in this population, these interventions have seen limited integration into clinical care and a lack of implementation research. Stepped care is a service innovation that may promote the implementation of these technologies into clinical settings, but few studies have examined how these services are designed in clinical settings. Objective: This study aimed to identify strategies to address health system barriers to accessing mental health care from the perspective of people living with heart failure, clinicians, and researchers, and to incorporate these strategies into the design of a virtual mental health stepped care service within a heart failure remote management program. Methods: A qualitative description study was conducted using purposive recruitment of people living with heart failure, clinicians, and researchers from a heart failure remote patient management program. As part of a service design approach, semistructured interviews explored potential strategies to address barriers to accessing mental health services. Two researchers coded the data descriptively and constructed themes to guide the development of a virtual stepped care service. Results: A total of 22 participants were interviewed, comprising 13 people living with heart failure and 9 clinicians and researchers. Six themes were identified, comprising 4 requirements and 2 foundational principles. The requirements were to (1) adopt a collective approach to identify distress across methods, people, and time points; (2) maintain a referral-based approach; (3) rely on existing mental health human resources; and (4) offer patient choice among various mental health care options. These requirements were supported by two principles: (1) building on organizational strengths and (2) reducing treatment burden. Based on these findings, a virtual stepped care service was developed, incorporating a depression screening module, referral-based workflows, and, where clinically appropriate, patient choice in treatment selection. Conclusions: The stakeholder-informed design of this virtual stepped care service contributes to the limited literature on stepped care service design and demonstrates how such models can be tailored to their intended contexts. Although each component was designed to address health system barriers to mental health care for people living with heart failure, resource limitations may constrain the balance between feasibility and quality of care. Future research should evaluate the acceptability of this model among people living with heart failure and clinicians.
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