一项由教练指导的个性化抑郁风险沟通计划对重度抑郁发作风险的影响：一项随机对照试验的研究方案

The impact of a coach-guided personalized depression risk communication program on the risk of major depressive episode: study protocol for a randomized controlled trial.

作者信息

Wang JianLi, Feng Cindy, Hajizadeh Mohammad, Lesage Alain

机构信息

Department of Community Health & Epidemiology, Faculty of Medicine, Dalhousie University, Halifax, Canada.

Department of Psychiatry, Faculty of Medicine, Dalhousie University, Halifax, Canada.

出版信息

BMC Psychiatry. 2024 Dec 18;24(1):916. doi: 10.1186/s12888-024-06393-9.

DOI:10.1186/s12888-024-06393-9

PMID:39696180

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11654057/

Abstract

BACKGROUND

Depression is a highly prevalent and disabling mental health problem. Self-help has been strongly advocated for dealing with depression. Built upon the research on risk prediction modeling and risk communication, we developed a coach-guided, personalized depression risk communication tool (PDRC) for sharing information about individualized depression risk and evidence-based self-help strategies. The primary objective of this project is to evaluate the impact of the PDRC on the 12-month risk of major depressive episode (MDE) in Canadians who are at high risk of MDE.

METHODS

This is an assessor-blinded randomized controlled trial (RCT) with two arms. We will recruit 500 males and 500 females in the communities across the country. Individuals are eligible, if they: (1) are 18 years or older, (2) have not had a depressive episode in the past two months, (3) are at high risk of MDE based on the sex-specific risk predictive algorithms for MDE (predicted risk of 6.5% + for men and of 11.2% + for women), (4) can communicate in either English or French, and (5) agree to be contacted for follow-up interviews. After screening and baseline assessment, participants will be randomized by sex into intervention and control group in a 1:1 ratio. Participants in the intervention group will receive the coach-guided PDRC. The participants are assessed at baseline, 3 and 12 months via computer assisted telephone interview system, regarding the presence of MDE, depressive and anxiety symptoms, use of self-help strategies, mental health services use and self-efficacy.

DISCUSSION

The coach-guided PDRC may empower users to actively engage in self-management, leading to reduced risk of MDE. If successful, the coach-guided PDRC will lead to a novel selective prevention program that is closely aligned with the tiered mental health services model, contributing to early prevention of depression and better mental health wellbeing.

DATE OF TRIAL REGISTRATION

2024-10-02.

PROTOCOL VERSION AND DATE

December 6, 2024. Version #1.

TRIAL REGISTRATION

NCT06619366.

摘要

背景

抑郁症是一种高度普遍且使人致残的心理健康问题。自助疗法一直被大力提倡用于应对抑郁症。基于风险预测模型和风险沟通的研究，我们开发了一种由教练指导的个性化抑郁症风险沟通工具（PDRC），用于分享关于个体抑郁症风险和循证自助策略的信息。本项目的主要目标是评估PDRC对加拿大有高抑郁症发作（MDE）风险人群12个月内发生重度抑郁发作（MDE）风险的影响。

方法

这是一项有两个组别的评估者盲法随机对照试验（RCT）。我们将在全国社区招募500名男性和500名女性。符合以下条件的个体即为 eligible：（1）年龄在18岁及以上；（2）在过去两个月内未出现抑郁发作；（3）根据MDE的性别特异性风险预测算法，有高MDE风险（男性预测风险为6.5%及以上，女性为11.2%及以上）；（4）能够用英语或法语交流；（5）同意接受随访访谈。经过筛选和基线评估后，参与者将按性别以1:1的比例随机分为干预组和对照组。干预组的参与者将接受由教练指导的PDRC。通过计算机辅助电话访谈系统，在基线、3个月和12个月时对参与者进行评估，内容包括是否存在MDE、抑郁和焦虑症状、自助策略的使用情况、心理健康服务的使用情况以及自我效能感。