JMIR Publications

ABSTRACT

Background:

Internet-based self-help interventions (IBIs) for depressive symptoms, in which the main component is often a web-based self-help program, have 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 human and automated support before and during the use of a self-help program.

Objective:

The present study aims to better understand the effects of four supportive contextual factors on outcome of and adherence to a web-based self-help program for depressive symptoms. In a factorial experiment, two of the four supportive factors, for which there is evidence for their role on outcome and adherence, are realized during the intervention, i.e., personal guidance and automated e-mail reminders. The other two factors are realized before the intervention, i.e., a diagnostic interview and a pre-intervention module aimed at increasing the use of the program with motivational interviewing (MI) techniques.

Methods:

The study is a single-blinded, full factorial randomized trial. Adults with mild to moderate depressive symptoms (operationalized as Patient Health Questionnaire-9 (PHQ-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 four experimental factors, each reflecting the presence versus absence of a supportive factor (guidance, automated reminders, diagnostic interview, pre-intervention 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 (e.g., treatment expectancy, problem-solving skills, working alliance with the study team) will also be investigated.

Results:

Ethical approval was received on January 20th, 2020. As of August 5th, 2020, 220 participants are included in the study. Recruitment for a total of 255 participants is ongoing. Data completion is expected in December 2020.

Conclusions:

A better understanding of relevant supportive factors in the dissemination of web-based interventions is necessary to improve outcome 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. Clinical Trial: ClinicalTrials.gov NCT04318236 https://clinicaltrials.gov/ct2/show/NCT04318236