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临床试验/NCT06619366
NCT06619366招募中不适用

The Impact of Coach-guided Risk Communication on the Risk of Major Depression: A Randomized Controlled Trial

Dalhousie University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
The proportion of major depressive episode cases

研究概览

简要总结

Depression is a highly prevalent and disabling mental health problem. One way of preventing depression is to stop it before it happens through effective self-management. Working with potential users, a coach-guided, personalized depression risk communication tool (PDRC) was developed for sharing information about individualized depression risk, risk profile (risk factors present), potential risk reduction and evidence-based self-help strategies. It is anticipate that the PDRC will greatly motivate users to actively engage in self-help and help seeking, leading to a reduced risk of depression. The proposed study will recruit 500 male and 500 female adults who are at high risk of having depression across Canada, and randomly allocate them into the intervention and control groups. Participants will be followed for 12 months. The data of the trial will allow us to answer the questions: (1) Can the coach-guided PDRC reduce the risk of depression? (2) Does the intervention motivate people to actively engage in evidence-based self-help and help-seeking behaviors? (3) For whom the intervention works best? and (4) what are the costs and potential savings associated with the intervention? If successful, this project will offer a novel and effective tool for early prevention of major depression in the Canadian general population, help us understand how it works and the cost-effectiveness of implementing such a tool in the community from the economic perspective.

详细描述

Background and importance:

Depression is a highly prevalent and disabling mental health problem. One cost-effective way of reducing the disease burden associated with depression is selective prevention, i.e., identifying individuals who are at high risk of depression, and intervene before it happens. The investigators developed the first sex-specific multivariable risk predictive algorithms (MVRPs) for major depressive episode (MDE) using data from over 10,000 Canadians. Using the MVRP as the foundation and working with future users, the investigators developed a coach-guided personalized depression risk communication tool (PDRC) for sharing information about individualized depression risk, risk profile (risk factors present), potential risk reduction and self-help strategies. It is anticipate that the coach-guided PDRC will greatly motivate users to actively engage in self-help and help-seeking, leading to a reduced risk of depression in the population.

Goals/Research Aims:

The aims of the proposed randomized controlled trial (RCT) are to evaluate the impacts of the coach-guided PDRC on: (1) the risk of MDE at 12 months, (2) self-help and help-seeking behaviors, (3) the severity of depressive symptoms, and to examine (4) the moderation effect by self-efficacy and (5) the cost effectiveness of the coach-guided PDRC.

Methods/Expertise:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

The follow-up assessments will be conducted at the PI's telephone interview laboratory. Over the study period, investigators will be blinded to participants' group status. The survey firm interviewers who conduct baseline assessment and randomization, will not be involved in follow-up interviews. The interviewers who conduct the follow-up interviews will not have access to participants' group status. The coaches will not be involved in follow-up assessments. Given our description of study objectives, participants may know their group status. After the 12-month interview, group status will be linked with interview data by study identification numbers.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • no MDE at baseline, or full remission for 2 months for those who had a past MDE (see below the question).
  • Aged 18 and 65 years.
  • At high risk of MDE based on the depression risk calculators (predicted risk of 6.5%+ for males and 11.2%+ for females), which represent the top two deciles of male and female populations in Canada.
  • Agreement to be contacted for follow-up assessments, and
  • no language barriers to English or French

排除标准

  • individuals who
  • cannot provide informed consent,
  • do not agree to be followed,
  • cannot communicate in English and French, or
  • report suicide behaviors (score >0 on item 9 of the Patient Health Questionnaire (PHQ-9)).

结局指标

主要结局

The proportion of major depressive episode cases

时间窗: 12 months after randomization.

The proportion of new onset major depressive episode cases measured by the Composite International Diagnostic Interview (CIDI).

次要结局

  • Depressive symptom score(3 and 12 months)
  • change in self-help behaviors(3 and 12 months)
  • The percentage of mental health service use(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JianLi Wang

Professor

Dalhousie University

研究点 (2)

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