Optimizing the Context of Support to Improve Outcomes of Internet-Based Self-help in Individuals With Depressive Symptoms: Protocol for a Randomized Factorial Trial.

Bur, Oliver Thomas; Krieger, Tobias; Moritz, Steffen; Klein, Jan Philipp; Berger, Thomas (2021). Optimizing the Context of Support to Improve Outcomes of Internet-Based Self-help in Individuals With Depressive Symptoms: Protocol for a Randomized Factorial Trial. JMIR research protocols, 10(2), e21207. JMIR Publications 10.2196/21207

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

07 Faculty of Human Sciences > Institute of Psychology > Clinical Psychology and Psychotherapy

UniBE Contributor:

Bur, Oliver; Krieger, Tobias and Berger, Thomas

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1929-0748

Publisher:

JMIR Publications

Language:

English

Submitter:

Andrea Stettler

Date Deposited:

12 Feb 2021 15:02

Last Modified:

12 Feb 2021 15:07

Publisher DOI:

10.2196/21207

PubMed ID:

33528377

Uncontrolled Keywords:

adherence depression digital health factorial design internet-based intervention mental health multiphase optimization strategy online problem-solving therapy self-help

BORIS DOI:

10.48350/152204

URI:

https://boris.unibe.ch/id/eprint/152204

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