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

Autor: Simon Provoost, Tibor Bosse, Annet Kleiboer, Pim Cuijpers, Artur Rocha, Heleen Riper, José Pedro Ornelas, Jeroen Ruwaard
Přispěvatelé: Clinical Psychology, APH - Mental Health, APH - Global Health, Computer Science, World Health Organization (WHO) Collaborating Center, APH - Personalized Medicine, Psychiatry
Jazyk: angličtina
Rok vydání: 2020
Předmět:
medicine.medical_specialty
020205 medical informatics
Population
Virtual coach
Psychological intervention
Medicine (miscellaneous)
Pilot Projects
Low mood
02 engineering and technology
law.invention
Automated support
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Intervention (counseling)
Study protocol
0202 electrical engineering
electronic engineering
information engineering
medicine
iCBT
Humans
Pharmacology (medical)
030212 general & internal medicine
education
Netherlands
Randomized Controlled Trials as Topic
Protocol (science)
Internet
education.field_of_study
lcsh:R5-920
Cognitive Behavioral Therapy
Depression
business.industry
Test (assessment)
Communication and Media
Mood
Adherence
Physical therapy
The Internet
business
Pilot RCT
lcsh:Medicine (General)
Internet-Based Intervention
Zdroj: Trials, Vol 21, Iss 1, Pp 1-12 (2020)
Provoost, S, Kleiboer, A, Ornelas, J, Bosse, T, Ruwaard, J, Rocha, A, Cuijpers, P & Riper, H 2020, ' Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial ', Trials, vol. 21, no. 1, 860 . https://doi.org/10.1186/s13063-020-04777-2
Trials, 21
Trials, 21(1):860. BioMed Central
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-020-04777-2
Popis: 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.
Databáze: OpenAIRE
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