Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial

• Main Authors: Simon Provoost, Annet Kleiboer, José Ornelas, Tibor Bosse, Jeroen Ruwaard, Artur Rocha, Pim Cuijpers, Heleen Riper
• Format: Article
• Language: English
• Published: BMC 2020-10-01
• Series: Trials
• Subjects: iCBT; Study protocol; Pilot RCT; Adherence; Virtual coach; Automated support
• Online Access: http://link.springer.com/article/10.1186/s13063-020-04777-2

Abstract Background Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach. Methods/design The study will employ a pilot two-armed randomized controlled trial design. The primary outcomes of the trial will be (1) the effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation. Secondary aims will be to assess the virtual coach’s effect on motivation, users’ perceptions of the virtual coach, and general feasibility of the intervention as supported by a virtual coach. We will recruit N = 70 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course. Candidates with symptoms of moderate to severe depression will be excluded from study participation. Included participants will be randomized in a 1:1 ratio to either (1) Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support. Assessments will be taken at baseline and post-study 4 weeks later. Discussion The study will assess the preliminary effectiveness of a virtual coach in improving adherence and will determine the feasibility of a larger-scale RCT. It could represent a significant step in bridging the gap between guided and unguided iCBT interventions. Trial registration Netherlands Trial Register (NTR) NL8110 . Registered on 23 October 2019.