A Self-Guided Mobile Mindfulness Intervention Embedded in Daily Routines for Adults With Mild to Moderate Psychological Distress: Randomized Controlled Trial

Background: Mobile mindfulness interventions have shown promise for reducing anxiety and depressive symptoms, but sustaining engagement remains a persistent challenge. Many digital programs still rely on formal practice that requires dedicated time, which may be difficult to integrate into daily life. Objective: This randomized controlled trial evaluated Habitual Mindfulness Practice (HMP), a self-guided mobile mindfulness intervention that embeds brief practices into recurring daily routines, among adults with mild to moderate psychological distress. Outcomes were compared with those of Traditional Mindfulness (TM), Mindfulness-Based Psychoeducation (MBP), and a waitlist control (WL). Methods: Adults aged 18 to 65 years with mild to moderate symptoms of anxiety or depression were randomly assigned in a 1:1:1:1 ratio to HMP, TM, MBP, or WL (N=686). All procedures were conducted online, and the intervention was fully self-guided, with outcomes assessed using self-report measures. The intervention lasted 21 days, with assessments conducted at baseline, postintervention, and 3-month follow-up. Primary outcomes were depressive and anxiety symptoms. Secondary outcomes included mindfulness, cognitive emotion regulation, affective balance, and interpersonal difficulties. Postintervention group differences were examined, controlling for baseline scores, and longitudinal trajectories were evaluated across the active intervention conditions. Results: At postintervention, significant group effects were observed for depressive symptoms (=28.67, <.001, ηp²=0.11) and anxiety symptoms (=30.11, <.001, ηp²=0.12). Both HMP and TM showed lower depressive and anxiety symptom scores than MBP and WL. TM showed lower postintervention anxiety than HMP (=.04), whereas depressive symptoms did not differ significantly between HMP and TM (=.63). The mindfulness practice conditions also showed more favorable postintervention outcomes for mindfulness, affective balance, interpersonal difficulties, and emotion regulation. Improvements in depressive and anxiety symptoms were generally maintained at follow-up among the active intervention conditions, although maintenance of secondary outcomes varied across measures. Postintervention outcome data were available for 55.2% (379/686) of randomized participants, and follow-up outcome data were available for 24.1% (124/515) of participants in the active intervention conditions. HMP and TM did not differ significantly in practice duration, engagement, or satisfaction. Conclusions: A routine-embedded, self-guided mobile mindfulness intervention may be a feasible approach for reducing mild to moderate psychological distress. HMP produced benefits broadly comparable to those of traditional app-delivered mindfulness, but it did not confer advantages in engagement or short-term efficacy. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400093771; https://tinyurl.com/3d6tky8v

enDigital Postpartum Support for Early Risk Identification Among Postpartum Women: Formative Randomized Evaluation and Exploratory Predictive Modeling Study

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

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

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