---
title: "Digital eMPower program reduces anxiety and depression in adults with chronic conditions: randomiz"
id: "plos-medicine-0-effect-of-a-digital-intervention-on-mental-health-symptoms-in-adults-with"
canonical_url: "https://medichelpline.com/clinical-feed/plos-medicine-0-effect-of-a-digital-intervention-on-mental-health-symptoms-in-adults-with"
content_type: "clinical_feed_article"
specialty: "General"
source_name: "PLOS Medicine"
source_url: "https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005198"
published_at: "2026-08-20T14:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Digital eMPower program reduces anxiety and depression in adults with chronic conditions: randomiz
## Provenance & Clinical Metadata
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- **Specialty:** [General](https://medichelpline.com/clinical-feed/general.md)
- **Primary Source:** PLOS Medicine
- **Source URL:** [Original Journal Publication](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005198)
- **Published At:** 2026-08-20T14:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- A fully remote, three-arm randomized controlled trial (N = 825) tested a multicomponent **digital intervention** (eMPower) delivered either as **self-directed** or with brief **human support**, versus a waitlist control across 13 countries between Feb 2023 and Dec 2024. - Eligible participants were adults (initially ≥50, later ≥18) with self-reported physician-diagnosed chronic physical conditions and internet access; 84.2% (695) completed 12-week assessments. - Randomization allocated 274 to control, 275 to self-directed eMPower, and 276 to eMPower + human support; primary outcome data were available for 259 (control), 214 (self-directed), and 222 (human support). - The primary outcome was change in **HADS** (Hospital Anxiety and Depression Scale) total score at 12 weeks, adjusted for baseline score, chronic condition type, age, and sex. - In the prespecified primary comparison, eMPower + human support improved HADS total by 2.9 points (95% CI 2.0–3.8; p < 0.001) versus control. - In prespecified exploratory analyses, the self-directed eMPower arm also improved HADS total versus control (mean difference 2.6 points; 95% CI 1.8–3.5; p < 0.001); no significant differences were found between the two intervention arms. - Both intervention arms showed improvements on prespecified secondary outcomes (HADS subscales, fatigue by **MFIS**, SF-12 mental/physical component scores, and **EQ-5D-5L** index) compared with control; all secondary outcomes remained significant after multiplicity corrections in reported analyses. - The eMPower program combined video-guided movement, breathwork/meditation, an ACT-informed coping skills curriculum, and disease-specific education; human support consisted of weekly ≤15-minute check-ins from trained nonclinicians using a semi-structured script. - No intervention-related adverse events were reported. Key limitations noted by the authors include the waitlist control design, reliance mainly on self-reported diagnoses, 12-week follow-up only, and a predominantly female, highly educated sample that may limit generalizability. - Trial registration: ClinicalTrials.gov NCT05786482. Additional process and exploratory outcomes, longer-term follow-up, and cost-effectiveness analyses are planned in companion publications.
## Clinical Analysis & Structured Key Points
Effect of a digital intervention on mental health symptoms in adults with chronic conditions: A three-arm randomized controlled trial | PLOS Medicine Article Authors Metrics Comments Media Coverage Reader Comments Figures Figures 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 + human support arm compared with the control arm, adjusted for baseline score, chronic condition type, age, and sex. Secondary outcomes included HADS anxiety and depression subscales, fatigue (Modified Fatigue Impact Scale [MFIS]), and health-related quality of life (Short Form-12 [SF-12] mental and physical component scores and EQ-5D-5L index score). Twelve-week assessments were completed by 695 participants (84.2%). Primary outcome data were available for 222 participants in the eMPower + human support arm, 214 in the self-directed eMPower arm, and 259 in the control arm. Analyses followed the intention-to-treat principle. In the prespecified primary comparison, eMPower + human support improved HADS total score by 2.9 points (95% CI [2.0, 3.8]; p 0.05). Both intervention arms were associated with improvements across prespecified secondary outcomes compared with control. No intervention-related adverse events were reported in any arm. Key limitations include the use of a waitlist control design, which does not control for nonspecific intervention effects; reliance on self-reported diagnoses for most participants; the 12-week follow-up period; and a predominantly female and highly educated sample, which may limit generalizability. Additional registered process-oriented secondary outcomes and exploratory outcomes will be reported in companion publications. Conclusions A multicomponent digital intervention with human support significantly reduced anxiety and depression symptoms compared with usual care in adults with chronic medical conditions. Comparable effects between self-directed and human-supported delivery in exploratory analyses highlight potential for scalable, low-resource implementation. Longer-term follow-up and cost-effectiveness analyses are warranted. Trial registration: ClinicalTrials.gov: NCT05786482. Author summary Why was this study done? Anxiety, depression, and fatigue are highly prevalent across chronic medical conditions and are major drivers of disability and reduced quality of life. Access to effective symptom management support is limited by mobility barriers, geography, cost, and shortages of trained clinicians, creating an urgent need for scalable, low-resource approaches. Digital programs show promise, but most randomized trials are small and single-condition, and it remains unclear whether adding human support meaningfully improves outcomes, an uncertainty that directly affects real-world implementation decisions. What did the researchers do and find? In a fully remote, three-arm randomized controlled trial across 13 countries ( n = 825), researchers compared a waitlist control, a self-guided multicomponent digital program (movement, breathwork/meditation, coping skills, and disease education), and the same program plus brief weekly support from trained nonclinicians. At 12 weeks, the program reduced anxiety and depression symptoms and fatigue, and improved quality of life compared with usual care, with all secondary outcomes remaining significant after multiplicity corrections, demonstrating clinically meaningful benefits in a medically complex cohort. Outcomes did not differ between the self-directed and human-supported formats. What do these findings mean? A single, cross-condition digital intervention can improve mental health and fatigue outcomes for adults living with diverse chronic conditions. Comparable effects with and without weekly check-ins suggest a “digital first” model may be feasible for broad implementation. The study measured outcomes only over 12 weeks, most diagnoses were self-reported, and participants were predominantly women with higher education, so longer-term impact and generalizability to more diverse populations remain uncertain. Citation: Johnson E, Hyde A, Corrick S, Isley S, Wright G, Ezekowitz J, et al. (2026) Effect of a digital intervention on mental health symptoms in adults with chronic conditions: A three-arm randomized controlled trial. PLoS Med 23(8): e1005198. https://doi.org/10.1371/journal.pmed.1005198 Academic Editor: Alexander C. Tsai, Massachusetts General Hospital, UNITED STATES OF AMERICA Received: September 24, 2025; Accepted: July 17, 2026; Published: August 20, 2026 Copyright: © 2026 Johnson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability: Summary statistics and all values used to build graphs are reported within the manuscript tables and supplementary files. Individual participant-level data underlying these results cannot be shared publicly because participants provided informed consent for use of their data for this study and related analyses only, and the University of Alberta Health Research Ethics Board (HREB) does not permit unrestricted public deposition of these data. De-identified participant-level data may be made available to qualified researchers subject to approval by the University of Alberta HREB and execution of a data sharing agreement. Requests should be directed to the study’s designated data custodian at empower@ualberta.ca , who will coordinate the review process in accordance with institutional ethics and data governance policies. Funding: This study received funding from the Canadian Institutes of Health Research (CIHR) ( https://cihr-irsc.gc.ca ) grant number 179974 to PT; Mitacs ( https://www.mitacs.ca/ ) through the Canadian PBC Society and HeartLife to SC and SI (no formal grant number assigned); and TRIANGLE ( https://triangleprogram.org/ ) to EJ (no formal grant number assigned). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: The authors have declared that no competing interests exist. Abbreviations: ACT, acceptance and commitment therapy; COPD, chronic obstructive pulmonary disease; GDPR, General Data Protection Regulation; HADS, Hospital Anxiety and Depression Scale; LOCF, last observation carried forward; MCID, minimum clinically important difference; MFIS, Modified Fatigue Impact Scale; PBC, Primary Biliary Cholangitis; RCTs, randomized controlled trials; SD, standard deviation; SME, standardized mean difference; VAS, Visual Analog Scale. Introduction Chronic medical conditions affect more than 1 billion people worldwide and are a major contributor to disability, premature mortality, and healthcare utilization [ 1 ]. Symptoms of anxiety, depression, and fatigue occur in >50% of patients living with a range of chronic conditions [ 1 , 2 ], resulting in reduced daily functioning, quality of life, and capacity for self-management [ 1 , 2 ]. Digital health interventions offer scalable approaches to symptom management by reducing barriers related to geography, mobility, time [ 3 ], and limited healthcare resources [ 4 – 7 ], but important evidence gaps remain. A 2024 systematic review of 56 randomized controlled trials (RCTs) ( n = 7,691) [ 8 ] identified that minimally human-supported digital mind-body interventions, while effective, were often underpowered (median sample 40%), and rarely combined psychological and physical components [ 8 ]. Most interventions targeted single conditions, despite evidence that fatigue, anxiety, and depression are common across chronic diseases and share overlapping management principles [ 8 ]. In addition, limited evidence exists on whether human support is needed to enhance intervention effectiveness [ 8 – 10 ]. The eMPower trial evaluated a multicomponent digital intervention targeting anxiety, depression, and fatigue in adults with diverse chronic conditions. The primary study question was whether the eMPower intervention delivered with human support would improve symptoms of anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS) total score, compared with usual care at 12 weeks. It was hypothesized that human-supported delivery would improve mental health outcomes compared with control, with secondary benefits for fatigue and quality of life, and would outperform self-directed delivery. Methods Ethics statement This study was approved by the University of Alberta Health Research Ethics Board–Health Panel (Pro#00122568). All participants provided written informed consent electronically via Research Electronic Data Capture (REDCap) [ 11 ] prior to completing baseline assessments and randomization. As the trial was conducted entirely online from a single coordinating center with no in-person visits or local research sites, the University of Alberta Health Research Ethics Board served as the sole ethics board of record for all participants regardless of country of residence. A supplementary consent addressing General Data Protection Regulation (GDPR) requirements was obtained for participants in applicable jurisdictions. All protocol amendments were approved by the Ethics Board prior to implementation. Study design and participants Recruitment occurred between February 12, 2023 and June 16, 2024. The final participant completed 12-week follow-up on December 1, 2024. The trial was registered on ClinicalTrials.gov (Identifier: NCT05786482, Date of registration: March 9, 2023) [ 12 ] and is reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) (see S1 Checklist ) [ 13 ]. Trial modifications are documented using the CONSERVE-CONSORT Checklist ( S2 Checklist ). The trial was registered retrospectively, ~25 days after enrollment of the first participant, due to administrative delays including institutional account setup and entry of required protocol fields on ClinicalTrials.gov. No changes were made to the study design, outcomes, or analysis plan between enrollment of the first participant and trial registration, and registration was completed before any primary outcome data were collected. All data analyses were completed after end-of-study (December 1, 2024), with no interim analyses. Eligible participants were adults (≥18 years) with a self-reported physician-diagnosed chronic physical condition of at least 3 months’ duration requiring ongoing management [ 14 ]. Additional eligibility criteria included English proficiency and internet access. Participants reported a primary physician-diagnosed chronic physical condition at screening and provided current medication lists. For participants residing in Alberta, Canada who provided personal health numbers (39%), diagnoses were verified through provincial electronic medical records. For others, reported diagnoses were reviewed by a study physician using medication lists and available clinical information. The total number of chronic conditions per participant was not collected. At trial initiation, eligibility was restricted to adults ≥50 years. On May 19, 2023 (after 180 participants were enrolled), the minimum age was lowered to ≥18 years following steering committee review to improve inclusivity and align eligibility with the trial’s cross-condition design. Initial exclusion criteria included living with an uncontrolled psychiatric condition (post-traumatic stress disorder, bipolar disorder, or schizophrenia); near-daily suicidality; and Hospital Anxiety and Depression Scale (HADS)-Depression subscale score >10. Psychiatric conditions were considered uncontrolled if participants reported recent hospitalization, acute crisis, or lack of ongoing treatment. On October 21, 2023 (after 321 participants were enrolled), the HADS-Depression >10 exclusion was removed following consultation with psychiatrists and patient partners to improve equitable access, while retaining exclusion for near-daily suicidality and uncontrolled psychiatric illness. All amendments were approved by the University of Alberta Health Research Ethics Board prior to implementation and are detailed in the published trial protocol [ 12 ]. Procedures Participants were recruited entirely online through multiple channels: email lists and websites of patient partner organizations (including HeartLife, the Canadian PBC Society, the Canadian Liver Foundation, and the Canadian Digestive Health Foundation), social media platforms, online patient forums, and patient conferences. Clinical centers affiliated with the study team were also informed about the trial and provided with advertisement materials. All channels directed interested individuals to the study recruitment website, where they could access study information, provide electronic informed consent, and complete baseline assessments via REDCap [ 11 ]. Recruitment prioritized conditions with existing patient partner collaborations (e.g., heart failure, post-transplant, chronic digestive disease, liver disease), while an ‘other chronic condition’ category permitted enrollment of individuals with additional chronic conditions, supporting the intervention’s cross-condition approach. To support data integrity, research staff manually reviewed names and email addresses prior to orientation to prevent duplicate enrollment and maintained tracking logs documenting orientation attendance and study communication. Automated survey timestamps were monitored, with manual follow-up as needed. Randomization and masking Participants were randomized to one of three groups: control, self-directed eMPower, or eMPower + human support. Randomization was conducted electronically in REDCap [ 11 ] using computer-generated permuted blocks of size 6 within eight predefined chronic medical condition strata in a 1:1:1 allocation ratio. The allocation sequence was generated by the study statistician and uploaded to REDCap prior to recruitment. Allocation concealment was maintained until assignment. Due to the nature of the intervention, participant blinding was not feasible. Interventions The eMPower intervention, co-designed with patients [ 15 , 16 ], and informed by the capability, opportunity, motivation-behavior (COM-B) model [ 17 ], incorporated 22 behavior change techniques to support adherence ( S1 Table ) [ 18 ]. The program consisted of two components: Expert-led breathwork, meditation and movement (e.g., chair exercise, yoga, and Tai-chi) videos at multiple difficulty levels and lengths (full-length routines 20–35 min, short routines 3–10 min) Psychologist-led coping skills curriculum (e.g., values clarification, pacing strategies) based on principles of Acceptance and Commitment therapy (ACT). This was complemented by disease-specific education videos delivered by clinicians with expertise in each condition area, designed to support understanding and self-management (~5–15-min) (see S8 Table for topics). Participants were assigned educational content based on their primary chronic condition reported at enrollment; no additional tailoring was provided for comorbid conditions Participants in the eMPower + human support arm received weekly telephone check-ins (≤15 min) with nonclinical personnel who completed pre-study training (a 2-day course) in motivational interviewing. Check-ins followed a semi-structured script adapted from previous trials ( S2 File ) [ 16 , 19 ]. Both intervention groups received weekly newsletters highlighting program content ( S3 File ) and had the option to join weekly guided group movement sessions. All intervention content, newsletters, and check-in calls were delivered in English. Control participants were assigned to a waitlist control condition, in which they continued their usual medical care, received weekly emails containing motivational wellness quotes, and were offered access to the self-directed program after the 12-week study period. No restrictions were placed on concomitant treatments. Outcomes The primary outcome was HADS total score at 12 weeks, analyzed using Analysis of Covariance (ANCOVA) with adjustment for baseline HADS total score, chronic condition type, and age and sex, given their known associations with digital intervention engagement and mental health outcomes [ 20 , 21 ]. Secondary outcomes included HADS anxiety and depression subscales (HADS-A, HADS-D), fatigue measured using the Modified Fatigue Impact Scale (MFIS) [ 22 ] and the mental and physical component summary scores of the 12-Item Short Form Survey (SF-12 MCS and PCS) [ 23 ]. Health-related quality of life was assessed using EQ-5D-5L index scores calculated with country-specific value sets [ 24 ]. The EQ-5D-5L Visual Analog Scale (VAS) score was collected and reported descriptively but was not included among the prespecified secondary endpoints for confirmatory testing [ 25 ]. Prespecified exploratory analyses included comparisons of the combined intervention arms versus control and comparisons between the two intervention arms. Participants were encouraged to report intervention-related adverse events to the study team throughout the trial period. Condition-specific quality-of-life measures prespecified in the published protocol were collected where applicable; however, because these instruments apply only to subsets of participants and would require condition-stratified analyses with limited power, they are not presented in this primary cross-condition report [ 12 ]. Two additional registered secondary outcomes, the Capability, Opportunity, Motivation, Behavior (COM-B) survey assessing behavioral drivers of engagement and a satisfaction and adherence measure, are process-oriented engagement measures being planned for separate implementation focused publications. Registered exploratory outcomes (demoralization, frailty, sleep disturbance, and healthcare usage) are similarly planned for separate focused analyses. Sample size and statistical analysis The sample size was powered for the single prespecified primary comparison: eMPower + human support versus control on HADS total score at 12 weeks. Sample si
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