Effect of a digital intervention on mental health symptoms in adults with chronic conditions: A three-arm randomized controlled trial
Abstract
Background: Anxiety, depression, and fatigue affect >50% of adults across a range of chronic medical conditions, leading to reductions in quality of life. Digital symptom management interventions may address this burden, but clinical trial evidence across diverse conditions is limited, and the added value of human support remains uncertain. This study aimed to determine whether a multicomponent digital intervention, delivered with or without human support, reduces anxiety and depression compared with usual care at 12 weeks in adults with chronic medical conditions, and whether human-supported delivery outperforms self-directed delivery.
Methods and findings: A three-arm parallel-group open-label randomized controlled trial was conducted from February 2023 to December 2024, with online recruitment and delivery across 13 countries. 825 adults (≥18 years) with self-reported chronic medical conditions and internet access were allocated by computer-generated stratified block randomization (1:1:1) to: (i) waitlist control (n = 274); (ii) eMPower, a self-directed digital program integrating video-guided movement, breathwork, and meditation practices, a psychology-based coping skills curriculum, and disease education (n = 275); or (iii) eMPower + human support consisting of weekly telephone check-ins (≤15 min) from trained nonclinicians (n = 276). The primary outcome was change in Hospital Anxiety and Depression Scale (HADS) total score from baseline to 12 weeks in the eMPower +…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 825 participants or records.
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