Optimizing the Context of Support to Improve Outcomes of Internet-Based Self-help in Individuals With Depressive Symptoms: Protocol for a Randomized Factorial Trial
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Abstract
Background: Internet-based self-help interventions for individuals with depressive symptoms, in which the main component is often a web-based self-help program, have been shown to be efficacious in many controlled trials. However, there are also trials on self-help programs showing no significant effect when delivered in routine care, and some studies report high dropout and low adherence rates. Research suggests that these findings do not emerge primarily due to the specific content of a self-help program. It seems more important how a program is embedded in the context of human and automated support before and during the use of a self-help program. Objective: This study aims to better understand the effects of 4 supportive contextual factors on outcomes of and adherence to a web-based self-help program for depressive symptoms. In a factorial experiment, 2 of 4 supportive factors, for which there is evidence for their role on outcomes and adherence, are realized during the intervention—personal guidance and automated email reminders. The other 2 factors are realized before the intervention—a diagnostic interview and a preintervention module aimed at increasing the motivation to use the program with motivational interviewing techniques. Methods: The study is a full factorial randomized trial. Adults with mild to moderate depressive symptoms (Patient Health Questionnaire–9 score: 5-14) are recruited from the community through the internet and conventional media. All participants receive access to a web-based self-help program based on problem-solving therapy. They are randomized across 4 experimental factors, each reflecting the presence versus absence of a supportive factor (guidance, automated reminders, diagnostic interview, preintervention module) resulting in a 16-condition balanced factorial design. The primary outcome is depressive symptoms at 10 weeks post assessment. Secondary outcomes include adherence to the program, anxiety, stress, health-related quality of life, possible negative effects, and treatment satisfaction. Potential moderators and mediators (eg, treatment expectancy, problem-solving skills, working alliance with the study team) will also be investigated. Results: Ethical approval was received on January 20, 2020. The study was initiated in February 2020, and 240 participants have been enrolled in the study as of November 1, 2020. Recruitment for a total of 255 participants is ongoing. Data collection is expected to be completed by May 2021. Conclusions: A better understanding of relevant supportive factors in the dissemination of web-based interventions is necessary to improve outcomes of and adherence to web-based self-help programs. This study may inform health care systems and guide decisions to optimize the implementation context of web-based self-help programs for depressive symptoms. Trial Registration: ClinicalTrials.gov NCT04318236; https://clinicaltrials.gov/ct2/show/NCT04318236 International Registered Report Identifier (IRRID): DERR1-10.2196/21207
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Spanhel, K., Hovestadt, E., Lehr, D., Spiegelhalder, K., Baumeister, H., Bengel, J., & Sander, L. B. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2022.832196 · Cited by 37 · see citing works
- Authors
- Bur, O. T., Krieger, T., Moritz, S., Klein, J. P., & Berger, T.
- Affiliations
- University of Bern (CH)
- University Medical Center Hamburg-Eppendorf (DE)
- University of Lübeck (DE)
- Corresponding author
- Bur, Oliver Thomas
- Venue
- JMIR Research Protocols
- Publisher
- JMIR Publications Inc.
- Published
- 2021-02-02
- Volume
- 10
- Issue
- 2
- Pages
- e21207
- ISSN
- 1929-0748 (ISSN-L)
- PMC
- PMC7886615
- OpenAlex
- W3117207675
- Cited by
- 7
- References
- 23
- Citations by year
- 2025: 1 · 2024: 1 · 2022: 4 · 2021: 1
- FWCI
- 1.13
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR Research Protocols (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- BORIS (University Library Bern) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Open Access CRIS of the University of Bern
- Funders
- University of Bern
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Keywords
- online self-help, depressive symptoms, problem-solving therapy, individual guidance, motivational interviewing, diagnostic interview, medication adherence, dropout, mild to moderate depression, treatment satisfaction, health-related quality of life, anxiety, stress, therapeutic relationship, treatment expectancy, problem-solving skills, community-based recruitment, factorial trial
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