Background: The postpartum period represents a critical window for maternal health, yet many individuals lack sustained support and timely identification of physical and mental health risks. Digital health interventions offer a scalable approach to extend care beyond clinical settings. Yet, key elements, including real-world challenges, usability, and effectiveness of such platforms, are insufficiently characterized in this literature. Objective: This study aimed to conduct a formative randomized evaluation to assess the feasibility, engagement, and preliminary signals of impact of the Joyuus platform and to examine the potential for early identification of postpartum health risks. Methods: We conducted a 12-week randomized evaluation with postpartum participants recruited through community-based organizations. Participants were randomized to either the Joyuus intervention or standard postpartum care. Primary and secondary outcomes included the Barkin Index of Maternal Functioning, the Edinburgh Postnatal Depression Scale (EPDS), the State-Trait Anxiety Inventory, and the Connor-Davidson Resilience Scale. Analyses were conducted using an intention-to-treat approach with linear regression models adjusting for baseline values. Engagement metrics (ie, sessions, time on site, and feature use) were captured through in-app analytics. An exploratory predictive model was developed using baseline clinical, behavioral, and demographic variables to identify individuals at risk for postpartum depression. Results: Baseline characteristics were generally balanced across arms, and no statistically significant differences were observed in education, income, or marital status. No statistically significant differences were found between treatment and control groups in the 12-week changes for the primary or secondary outcomes. Mean EPDS scores were 9.7 in the intervention group and 9.3 in the control group. In the sample, 60 (45.5%) of the 132 participants met the criteria for elevated depression (EPDS score ≥11 or a positive response to question 10 on self-harm), indicating a high burden of symptoms within the study population. Engagement with the platform was highest during the first 4 weeks. Among intervention participants, 80% created an account. Participants reported high levels of perceived usefulness, ease of use, and relevance of content. Qualitative analysis of open-ended survey responses highlighted limited awareness of postpartum-specific resources and a preference for simple, accessible information. An exploratory predictive model demonstrated a recall of 0.89 and a precision of 0.73 in identifying individuals at risk for postpartum depression, suggesting the feasibility of early risk identification using integrated data inputs. Conclusions: Joyuus demonstrated feasibility and acceptability but did not produce statistically significant improvements in maternal functioning or maternal health outcomes over 12 weeks. Joyuus identified high rates of depressive symptoms and early engagement patterns, which suggest an opportunity for earlier identification of risk and intervention during the postpartum period. Exploratory modeling results indicate the potential for data-driven approaches to support earlier detection. Future work includes optimizing engagement strategies and expanding validation of predictive detection to improve postpartum surveillance and outcomes. Trial Registration: ClinicalTrials.gov NCT05876559; https://clinicaltrials.gov/study/NCT05876559?cond=postpartum%20joyuus&viewType=Card&rank=1

TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder
Conditions: Autism Spectrum Disorder (ASD)
Interventions: Behavioral: Standard Hospital Care; Behavioral: Telehealth Applied Behavior Analysis (TeleABA)
Sponsors: Caring Technologies, Inc.; National Institute of Mental Health (NIMH); Hackensack Meridian Health; Center for Social Dynamics; Rutgers University
Not yet recruiting
Interventions: Behavioral: Standard Hospital Care; Behavioral: Telehealth Applied Behavior Analysis (TeleABA)
Sponsors: Caring Technologies, Inc.; National Institute of Mental Health (NIMH); Hackensack Meridian Health; Center for Social Dynamics; Rutgers University
Not yet recruiting
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
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
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
Interventions: Device: Virtual Reality Behavioral Activation Software; Behavioral: Waitlist Control and Psychoeducation
Sponsors: KTO Karatay University
Completed
Digital Mindfulness-Based Therapy for Obsessive-Compulsive Disorder
Conditions: Obsessive-Compulsive Disorder
Interventions: Behavioral: Digital Mindfulness-Based Therapy; Drug: Routine Pharmacological Treatment
Sponsors: Central South University; Second Xiangya Hospital of Central South University
Not yet recruiting
Interventions: Behavioral: Digital Mindfulness-Based Therapy; Drug: Routine Pharmacological Treatment
Sponsors: Central South University; Second Xiangya Hospital of Central South University
Not yet recruiting
A Sensory-Profile Framework for Differentiated Swim Instruction in Autistic Children
Conditions: ASD
Interventions: Behavioral: sensory-based instruction; Behavioral: standard instruction
Sponsors: Genesis Indep Research
Completed
Interventions: Behavioral: sensory-based instruction; Behavioral: standard instruction
Sponsors: Genesis Indep Research
Completed
HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder
Conditions: Binge Eating Disorder; Binge Eating Episodes; Binge Eating/Loss of Control Eating; Binge Eating Disorders; Binge Eating; Binge Eating Behaviour; Binge Eating Disorder Associated With Obesity; Eating Disorder Binge; Eating Disorders
Interventions: Behavioral: Cognitive Behavioral Therapy Enhanced – Individual; Behavioral: Cognitive Behavioral Therapy Enhanced – Group; Behavioral: Cognitive Behavioral Therapy – Guided Self Help; Behavioral: Systemic Narrative Therapy – Group
Sponsors: Herlev and Gentofte Hospital; Jascha Fonden; BETA-HEALTH Foundation; Mental Health Centre Ballerup; Region Capital Denmark; University of Copenhagen
Recruiting
Interventions: Behavioral: Cognitive Behavioral Therapy Enhanced – Individual; Behavioral: Cognitive Behavioral Therapy Enhanced – Group; Behavioral: Cognitive Behavioral Therapy – Guided Self Help; Behavioral: Systemic Narrative Therapy – Group
Sponsors: Herlev and Gentofte Hospital; Jascha Fonden; BETA-HEALTH Foundation; Mental Health Centre Ballerup; Region Capital Denmark; University of Copenhagen
Recruiting
Efficacy of a Gamified Blended Mindfulness Program to Reduce Burnout, Stress, and Anxiety in Nursing Students: A Randomized Controlled Trial
Conditions: Burnout Syndrome; Psychological Stress, Anxiety, and Depression Associated With Academic Pressure; Anxiety
Interventions: Behavioral: Psychoeducation and Free App Recommendation; Behavioral: Standard Blended Mindfulness Program; Behavioral: Gamified Blended Mindfulness Program
Sponsors: Universidad de Granada
Completed
Interventions: Behavioral: Psychoeducation and Free App Recommendation; Behavioral: Standard Blended Mindfulness Program; Behavioral: Gamified Blended Mindfulness Program
Sponsors: Universidad de Granada
Completed
The ECHO study: compassion-focused therapy for young voice hearers and their caregivers. A pilot study
BackgroundVoice hearing can occur in healthy people without a trigger, be caused by a traumatic event, or occur as part of a psychiatric disorder. There are still many gaps in our understanding of voice hearing, and research in this field can be challenging, maybe because it is associated with shame and stigma. Those who experience distress by voice hearing could benefit from a treatment, aimed directly at that. The ECHO manualized treatment is based on the principles of compassion-focused therapy (CFT).MethodsTreatment will take place on several different psychiatric hospitals in the Region of Southern Denmark. Treatment consists of a 10-session, manualized CFT for voice hearing. Caregivers participate in half of the sessions, and a recording of the voice content is made, which the caregivers are encouraged to listen to. The study is designed as a prospective single-arm pre–post intervention study using a mirror-image approach, in which participants serve as their own controls over time. The intervention group consists of (N = 60) voice-hearing adolescents aged 13–18 years. Additionally, a clinical comparison group (who also receive the intervention) of (N = 20) individuals aged 18–20 years with first-episode schizophrenia and voice hearing is included for descriptive and exploratory analyses. Data are collected 3 months prior to CFT treatment, immediately before the start of treatment, immediately after treatment is completed, and at 1 month follow-up. Data will be centered around social cognition, perceived social safeness, social connectedness, general well being, auditory hallucinations and compassion.DiscussionThe ECHO study addresses the wellbeing and thriving of an overlooked group of young people. The results of this study will provide information about who the voice hearers are, what challenges they face, and how they perceive them. The results will also provide information about the feasibility and efficacy of the treatment manual and, thus, its potential further implementability. Caregivers participate in half of the sessions, to facilitate a common language about mental states and voice hearing. To support their understanding, a recording of the voice content is made and the caregivers are encouraged to listen to it. We suggest that when caregivers understand the young voice hearers’ experiences, they can adjust their expectations and approach accordingly. We also suggest that by sharing the voice content, the young voice hearer will feel less isolated.Study protocol registrationhttps://clinicaltrials.gov/study/NCT07314515, identifier NCT07314515.
Autistic- and attention-deficit/hyperactivity disorder-like traits: differential associations with burnout, depression and anxiety, and empathy among Japanese junior residents
IntroductionBurnout, depression, and anxiety are major concerns among physicians because they affect individual well-being, patient care, and healthcare systems. Neurodevelopmental traits, including autistic-like traits (ALTs) and attention-deficit/hyperactivity disorder (ADHD)-like traits (ADHLTs), may increase vulnerability to psychological distress. However, little is known about how these traits relate to burnout, depression and anxiety, and empathy among junior residents.MethodsIn this cross-sectional study, 148 junior residents from two teaching hospitals in Japan completed validated measures of ALTs (21-item Japanese version of the Autism-Spectrum Quotient), ADHLTs (Adult ADHD Self-Report Scale Screener), burnout (Maslach Burnout Inventory), depression and anxiety (Hospital Anxiety and Depression Scale), physician–patient empathy (Jefferson Scale of Physician Empathy), and psychological flexibility and inflexibility processes (Valuing Questionnaire, Cognitive Fusion Questionnaire-7, and Work-related Acceptance and Action Questionnaire). Associations were examined using multivariable logistic and linear regression analyses. Exploratory statistical mediation analyses using structural equation modeling examined indirect associations through psychological flexibility and inflexibility processes.ResultsThe prevalence of ALTs and ADHLTs was 23.6% for each trait. ALTs were associated with lower personal accomplishment, a burnout dimension; higher depression and anxiety; and lower physician–patient empathy. ADHLTs were associated with greater emotional exhaustion, another burnout dimension. In exploratory statistical mediation analyses, progress toward values, a core process of psychological flexibility, showed a significant indirect association between ALTs and personal accomplishment, and the direct association was attenuated and no longer statistically significant after including the process variables. Significant indirect associations through progress toward values were also observed for the associations of ALT with depression and anxiety and empathy. Cognitive fusion, a core process of psychological inflexibility, showed a significant indirect association between ADHLTs and emotional exhaustion. Overall, neurodevelopmental traits were associated with distinct patterns of psychological functioning, suggesting variability in both vulnerability and adaptive processes.DiscussionNeurodevelopmental traits such as ALTs and ADHLTs were significantly associated with burnout dimensions, depression and anxiety, and physician–patient empathy among junior residents. Psychological flexibility and inflexibility processes, particularly progress toward values and cognitive fusion, may be relevant to these associations. Process-based support strategies may warrant further investigation for residents with elevated neurodevelopmental traits.Clinical trial registrationhttps://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R00005, identifier UMIN000046897.

