Trial results for the Behavior, Biology and Well-Being Study investigating Depression were posted on ClinicalTrials.gov on 2025-08-01, with 1157 participants enrolled.
Background
Depression is a common mental health condition characterized by persistent sadness and loss of interest. Effective management often involves a combination of psychotherapy and medication. Digital interventions, such as mobile applications, are emerging as accessible tools to support mental well-being and potentially alleviate symptoms. The Healthy Minds Program (HMP) app was developed as one such intervention, aiming to promote well-being among adults with elevated depression symptoms.
Trial design
This completed study, designated as Phase NA, enrolled 1157 participants from the United States with elevated depression symptoms. The trial investigated conditions including Depression and Psychological Distress. The central aim was to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. Participants were randomized to one of three groups: the HMP app for 4 weeks, an active control (Psychoeducation app, which was HMP without meditation practice), or a waitlist control (Usual Care).
Key results
The trial measured depression symptoms using the Patient Health Questionnaire - 8 (PHQ-8) score. Several mean scores were observed across the study groups:
- For the Healthy Minds Program (HMP) App group, observed mean PHQ-8 scores were 10.06 (Standard Deviation 4.85), 9.17 (Standard Deviation 4.72), 8.37 (Standard Deviation 4.75), and 7.88 (Standard Deviation 4.9).
- For the Psychoeducation App group, observed mean PHQ-8 scores were 9.85 (Standard Deviation 4.68), 8.8 (Standard Deviation 4.71), 8.28 (Standard Deviation 4.6), and 8.01 (Standard Deviation 4.84).
- For the Usual Care group, observed mean PHQ-8 scores were 9.79 (Standard Deviation 4.75), 9.45 (Standard Deviation 5.11), 9.03 (Standard Deviation 5.22), and 9.21 (Standard Deviation 4.93).
What this means
The observed PHQ-8 scores suggest that both the Healthy Minds Program (HMP) app and the Psychoeducation app were associated with lower depression symptom scores compared to usual care. Specifically, the HMP app group showed the lowest mean PHQ-8 score of 7.88 in the latest reported measurement, compared to 8.01 for the Psychoeducation app and 9.21 for usual care. These findings indicate that digital interventions like the HMP app could offer a supportive tool for individuals experiencing elevated depression symptoms, potentially contributing to improved well-being.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05183867, titled 'Behavior, Biology and Well-Being Study', were posted on 2025-08-01 on clinicaltrials.gov.