自我指导的数字心理健康干预中作用机制对依从性和结果的影响：一项带有中介分析的随机对照试验方案

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.

作者信息

Baumel Amit, Aderka Idan M

机构信息

Department of Community Mental Health, University of Haifa, Haifa, Israel.

Department of Psychology, University of Haifa, Haifa, Israel.

出版信息

JMIR Res Protoc. 2025 May 21;14:e71238. doi: 10.2196/71238.

DOI:10.2196/71238

PMID:40397492

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12138313/

Abstract

BACKGROUND

One of the main recognizable challenges in the digital mental health interventions field is that users adhere to these interventions in their unguided forms poorly. Studies have shown that a persuasive system design focused on encouraging users to make positive behavior changes in their lives can increase user engagement and a program's efficacy. This design approach can be referred to as therapeutic persuasiveness (TP) and includes a call to action, monitoring, ongoing feedback, and program adaptation based on user state. The goal of this 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 children's behavior problems.

OBJECTIVE

This study aims to (1) examine the impact of TP quality on usage, reduction in child behavior problems, and improvement in parenting variables; (2) examine the maintenance of treatment gains over a follow-up period; and (3) examine mediational pathways, including whether adherence to the program (measured by module completion rates) mediates reported changes.

METHODS

A randomized controlled trial will be conducted to compare 2 interventions that use 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 children aged 3-7 years with behavior problems who will be randomized into one of the 2 intervention arms. We will measure child behavior problems and related parenting variables at 5 time points: before (T1), during (T2 and T3), and after the intervention (T4 and T5). Program usage will be passively collected.

RESULTS

The study was funded in October 2023, and enrollment began in September 2024. As of the end of December 2024, 100 participants were enrolled in 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 function and their outcomes is crucial in advancing our understanding of what influences usage and outcomes.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06514326; https://clinicaltrials.gov/study/NCT06514326.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71238.

摘要

背景

数字心理健康干预领域一个主要的可识别挑战是，用户对这些非指导性形式的干预依从性较差。研究表明，一种专注于鼓励用户在生活中做出积极行为改变的劝导系统设计，可以提高用户参与度和项目效果。这种设计方法可称为治疗劝导性（TP），包括行动呼吁、监测、持续反馈以及基于用户状态的项目调整。本研究的目的是检验TP对非指导性数字心理干预中项目完成情况和结果的因果影响。我们旨在针对旨在治疗儿童行为问题的数字家长培训项目（DPT）来研究这些问题。

目的

本研究旨在（1）检验TP质量对使用情况、儿童行为问题减少以及养育变量改善的影响；（2）检验随访期间治疗效果的维持情况；（3）检验中介途径，包括对项目的依从性（以模块完成率衡量）是否介导报告的变化。

方法

将进行一项随机对照试验，比较两种干预措施，它们使用已确立的DPT中相同的循证成分，但在TP质量方面有所不同（标准：DPT-STD；强化TP：DPT-TP）。我们将从160个有3至7岁行为问题儿童的家庭中招募家长，这些家长将被随机分配到两个干预组之一。我们将在5个时间点测量儿童行为问题及相关养育变量：干预前（T1）、干预期间（T2和T3）以及干预后（T4和T5）。项目使用情况将被被动收集。