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Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense
Open accessAbstract
Importance: Advances in mobile technology have resulted in federal and industry-level initiatives to facilitate large-scale clinical research using smart devices. Although the benefits of technology to expand data collection are obvious, assumptions about the reach of mobile research methods (access), participant willingness to engage in mobile research protocols (engagement), and the cost of this research (cost) remain untested. Objective: To assess the feasibility of a fully mobile randomised controlled trial using assessments and treatments delivered entirely through mobile devices to depressed individuals. Design: Using a web-based research portal, adult participants with depression who also owned a smart device were screened, consented and randomised to 1 of 3 mental health apps for treatment. Assessments of self-reported mood and cognitive function were conducted at baseline, 4, 8 and 12 weeks. Physical and social activity was monitored daily using passively collected phone use data. All treatment and assessment tools were housed on each participant's smart phone or tablet. Interventions: A cognitive training application, an application based on problem-solving therapy, and a mobile-sensing application promoting daily activities. Results: Access: We screened 2923 people and enrolled 1098 participants in 5 months. The sample characteristics were comparable to the 2013 US census data. Recruitment via Craigslist.org yielded the largest sample. Engagement: Study engagement was high during the first 2 weeks of treatment, falling to 44% adherence by the 4th week. Cost: The total amount spent on for this project, including staff costs and β testing, was $314 264 over 2 years. Conclusions and relevance: These findings suggest that mobile randomised control trials can recruit large numbers of participants in a short period of time and with minimal cost, but study engagement remains challenging. Trial registration number: NCT00540865.
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“In depression, mobile apps have tracked changes in patient-reported mood [27-29] and have been used as part of randomized controlled trials to evaluate treatment efficacy [30].”
From Wearable technology for high-frequency cognitive and mood assessment in major depressive disorder: longitudinal observational study (2019) · cites this paper as [30]
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Self-citationPark, C., Zhu, J., Man, R. H. C., Rosenblat, J. D., Iacobucci, M., Gill, H., Mansur, R. B., & McIntyre, R. S. (2019) · Annals of Clinical Psychiatry · doi:10.1177/154733251903100409
“34 If shorter intervention periods produce more favorable effects (ie, reduce depressive symptoms and are capable of producing sustained responses), this could inform patient care (ie, user engagement and motivation can be sustained more easily over shorter periods).”
Subotic-Kerry, M., Mackinnon, A. J., Gallen, D., Baker, S. T. E., Parker, B., Achilles, M. R., Chakouch, C., Cockayne, N. L., Christensen, H. M., & O’Dea, B. (2025) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/s13034-025-00975-5
“A recent review found that app-based programs offering monetary incentives achieved higher retention rates compared to those without incentives [22, 23].”
Comtois, K. A., Smythe, P., Kerbrat, A. H., Kim, E., Crouch, N., Homiar, A., Mosser, B., Sams, N., Harvey, M. L., Bagge, C. L., et al. (2026) · Journal of Medical Internet Research · doi:10.2196/83637
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Markiewicz, A., Vuillermoz, E., Davis, C., & Riley, M. (2026) · doi:10.2196/preprints.103489
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“Outside of college student populations, the literature similarly underscores low rates of user uptake of digital mental health interventions [11,12].”
Giannakopoulou, A., Gordon, A. M., Gallen, C. L., Seaman, M., Fedele, D., & Anguera, J. A. (2026) · npj Digital Medicine · doi:10.1038/s41746-026-03233-w
Self-citationOved, N., Lerner, N., Assa, N., Bukowski, E., Simkin, T., Menestrina, Z., Pasqualotto, A., Fanourakis, M., Bavelier, D., Lipskaya‐Velikovsky, L., et al. (2026) · JMIR Serious Games · doi:10.2196/94986
Saulnier, K. G., VanTil, M., Kerbrat, A. H., Smythe, P., Ren, X., Cohen, T., Comtois, K. A., & Bagge, C. L. (2026) · Psychiatry Research · doi:10.1016/j.psychres.2026.117482
Metadata
- Authors
- Anguera, J. A., Jordan, J. T., Castaneda, D., Gazzaley, A., & Areán, P. A.
- Affiliations
- University of California, San Francisco (US)
- University of Washington (US)
- Corresponding author
- Areán, Patricia A
- Venue
- BMJ Innovations
- Publisher
- BMJ
- Published
- 2016-01
- Volume
- 2
- Issue
- 1
- Pages
- 14-21
- ISSN
- 2055-642X (ISSN-L)
- 2055-8074
- PMC
- PMC4789688
- OpenAlex
- W2261303017
- Cited by
- 172
- References
- 34
- Citations by year
- 2026: 7 · 2025: 10 · 2024: 19 · 2023: 13 · 2022: 19 · 2021: 22 · 2020: 21 · 2019: 22 · 2018: 17 · 2017: 16 · 2016: 6
- FWCI
- 31.18
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Innovations (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc)
- Funders
- University of California, San Francisco
- National Institute of Mental Health (MH100466, R34MH100466, K24MH074717, T32MH018261)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Mental Health Research Topics
- Keywords
- depression, mobile health apps, participant recruitment, participant engagement, trial costs, cognitive training, problem-solving therapy, mobile sensing, self-reported mood, cognitive function
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