Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 14, 2025
Date Accepted: Apr 21, 2025
The Impact of Mechanisms of Action on Adherence and Outcomes in Self-Guided Digital Mental Health Interventions: Protocol for a Randomized Controlled Trial with Mediation Analysis
ABSTRACT
Background:
One of the main recognizable challenges in the digital mental health interventions field is that users poorly adhere to these interventions in their unguided forms. Studies have shown that a persuasive system design focused on encouraging users to make positive behavior changes in their life can increase user engagement and a program’s efficacy. This design approach can be referred to as therapeutic persuasiveness (TP) and includes call to action, monitoring, ongoing feedback, and program adaptation based on user state. The goal of the current study is to examine the causal impact of TP on program completion and outcomes in unguided digital mental interventions. We aim to examine these questions in digital parent training programs (DPTs) aimed at treating child’s behavior problems.
Objective:
The current study objectives are (a) to examine the impact of TP quality on usage, reduction in child behavior problems, and improvement in parenting variables; (b) to examine the the maintenance of treatment gains over a follow-up period; and (c) to examine mediational pathways, including whether adherence to the program, measured by module completion rates, mediates reported changes.
Methods:
A randomized controlled trial (RCT) will be conducted to compare two interventions that utilize the same evidence-based components of established DPTs, but that differ in terms of the quality of TP (standard: DPT-STD; enhanced TP: DPT-TP). We will recruit parents from 160 families with 3–7-year-old children with behavior problems who will be randomized into one of the two intervention arms. We will measure child behavior problems and related parenting variables at five time points: before (T1), during (T2, T3), and after the intervention (T4, T5). Program usage will be passively collected.
Results:
The study was funded in October 2023 and enrollment began on September 2024. As of the end of December 2024, 100 participants were enrolled to the study. Analyses are expected to be completed by September 2027.
Conclusions:
Identifying conceptual scientific theories that draw a link between active ingredients embedded within a digital intervention functions and their outcomes is crucial in advancing our understanding of what influences usage and outcomes. Clinical Trial: clinicaltrials.gov registry, NCT06514326, https://clinicaltrials.gov/study/NCT06514326
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