Feasibility and preliminary effects of an app-based physical activity intervention for individuals with depression (MoodMover): A protocol for a single-arm, pre-post intervention study
Open accessAbstract
Depression is the leading cause of disability worldwide. Mobile app-based behavior change interventions that promote lifestyle physical activity (PA) may serve as viable alternatives or adjuncts to traditional treatments offering increased reach and accessibility. This protocol describes an experimental, pre-post single-arm trial to investigate the feasibility and preliminary effects of an app-based, 9-week PA intervention (MoodMover) designed for individuals with depression. MoodMover is co-designed with patients and a multidisciplinary research team using a no-code intervention development platform (Pathverse). This study will employ a single-arm pre-post trial with an optional 9-week follow-up, following the Obesity-Related Behavioral Intervention Trials (ORBIT) model. Thirty-six adults who self-report a clinical diagnosis of major depressive disorder or report at least mild depressive symptoms based on the Patient Health Questionnaire – 9 items (PHQ-9) will be recruited. The main outcomes of this study are the feasibility and acceptability of MoodMover, such as the recruitment strategy, assessments (e.g., PHQ-9), and user engagement. Preliminary effects will be assessed by evaluating changes in PA and depressive symptoms. Recruitment is expected to begin on November 1 st, 2024, and end on May 1 st, 2025. Trial results will be disseminated via publications in peer-reviewed journals and via presentations at academic conferences. This study fits within Phase IIa: Proof-of-concept and Phase IIb: Pilot and Preliminary Testing of the ORBIT model. The robust feasibility and acceptability measures, especially the user engagement data powered by Pathverse, will provide a comprehensive understanding of the MoodMover intervention’s feasibility and potential effects. Results will inform potential progression to the next step of the ORBIT model—Phase IIc: Phase II Efficacy Trial—to test MoodMover in a more rigorous randomized controlled trial. This study has been registered at ClinicalTrials.gov (NCT06573125; https://clinicaltrials.gov/study/NCT06573125).
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A sample size of 40 is on par with comparable hybrid human delivered pilot studies.
“When looking at hybrid human delivered pilot studies, a sample size of 40 is on par with comparable research [105, 106].”
From Personalized machine learning guided intervention for optimizing lifestyle behaviors in depression: a pilot study (2026) · cites this paper as [105]
The Materials and methods section (Sample size justification; page unavailable) proposes 20–36 participants for this single-arm pilot, so 40 is close to its planned sample size. The Intervention and Procedures sections describe an app-delivered program with a 15-minute researcher-led orientation, not a comparable hybrid human-delivered pilot study. (LLM, conf=0.82)
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- Authors
- Tang, Y., Gierc, M., La, H., Liu, S., Lam, R. W., Puterman, E., & Faulkner, G.
- Affiliations
- University of British Columbia (CA)
- University of Victoria (CA)
- Corresponding author
- Tang, Yiling
- Venue
- PLOS One
- Publisher
- Public Library of Science (PLoS)
- Published
- 2025-04-22
- Volume
- 20
- Issue
- 4
- Pages
- e0321958
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC12013873
- OpenAlex
- W4409660795
- Cited by
- 2
- References
- 68
- Citations by year
- 2026: 2
- FWCI
- 1.60
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Michael Smith Health Research BC (RT-2021-1718)
- Canadian Institutes of Health Research (GR003430)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Physiology › Physical Activity and Health
- Keywords
- depression, physical activity interventions, mobile health apps, lifestyle physical activity, depressive symptoms, feasibility and acceptability, user engagement, co-design, ORBIT model, major depressive disorder
- MeSH terms
- Adult, Depression, Feasibility Studies, Female, Humans, Male, Middle Aged, Exercise, Mobile Applications
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