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临床试验/NCT04519892
NCT04519892已完成不适用

A Pilot Study of the Effect of Personalized Depression Risk Communication

University of Calgary2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Change in self-help scores

研究概览

简要总结

Depression is a highly prevalent and disabling mental health problem. It is associated with significant morbidity and mortality and it has a significant economic impact. Effective and feasible strategies aimed at the population-level to reduce the risk of onset are urgently needed to manage this ubiquitous condition. Developed from research in the fields of epidemiology, mental health, and implementation science, the proposed intervention provides individualized information designed to trigger actions that can reduce the risk of MDE. Specifically, and as the first step, the investigators developed the first sex-specific multivariable risk predictive algorithms (MVRPs) for MDE using data from over 10,000 Canadians. This innovative early work shows that the risk of onset of MDE can be quantified in the same way as can other physical disorders such as cardiovascular diseases and cancer. Knowing the individualized risk estimated by the MVRPs may serve as a trigger to empower people to actively engage in effective self-help actions. Self-help strategies are commonly used to deal with depression and promoting effective self-help strategies to the public as an early intervention strategy has been recommended as one way to reduce the large disease burden of depression. Subsequently, the investigators conducted a randomized controlled trial (RCT) and found that providing individualized depression risk causes no psychological harm in participants. These studies have laid the required foundation for communicating individualized risk information to a broad population as a first step towards effecting changes in self-help and help-seeking behaviours and reducing the risk of MDE onset.

Using the MVRPs as the foundation and working with future users, the investigators developed a 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. At this stage of our research program, the investigators need to answer the question: Does the PDRC lead to positive changes in self-help and help-seeking behaviours? Prior to a large scale RCT, the investigators proposed to conduct a pilot study to gain preliminary understanding about the effect of PDRC on self-help and help-seeking behaviors. The results will inform the design of a large RCT.

详细描述

Depression is a highly prevalent and disabling mental health problem. It is associated with significant morbidity and mortality and it has a significant economic impact. Effective and feasible strategies aimed at the population-level to reduce the risk of onset are urgently needed to manage this ubiquitous condition. Developed from research in the fields of epidemiology, mental health, and implementation science, the proposed intervention provides individualized information designed to trigger actions that can reduce the risk of MDE. Specifically, and as the first step, the investigators developed the first sex-specific multivariable risk predictive algorithms (MVRPs) for MDE using data from over 10,000 Canadians. This innovative early work shows that the risk of onset of MDE can be quantified in the same way as can other physical disorders such as cardiovascular diseases and cancer. Knowing the individualized risk estimated by the MVRPs may serve as a trigger to empower people to actively engage in effective self-help actions. Self-help strategies are commonly used to deal with depression and promoting effective self-help strategies to the public as an early intervention strategy has been recommended as one way to reduce the large disease burden of depression. Subsequently, the investigators conducted a randomized controlled trial (RCT) and found that providing individualized depression risk causes no psychological harm in participants. Using the MVRPs as the foundation and working with future users, the investigators developed a 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.

Risk communication is the open two way exchange of information and opinions about harms and benefits, with the aim of improving the understanding of risk and of promoting better decisions about clinical management. Risk communication goes beyond simply sharing information about the probability of developing a problem (i.e., individualized risk); it also shares possible actions to be taken. The notable clinical guidelines for coronary heart disease (CHD) and the Institute of Medicine report recommend that baseline risk should be estimated; individuals should know their personal risk; and high-quality risk communication tools should be developed.

The existing literature reveals that effective risk communication often includes multiple components: (1) Individualized risk information presented as an absolute risk, as opposed to a relative risk. The risk information may also list the individual's risk factors. (2) Appropriate format of presentation (e.g., graphic, visual). The format of presentation can influence the degree to which individuals perceive their risk and will affect behavioural change. (3) Presentation of risk reduction. A review of evidence recommends that information on risk reduction should be presented using absolute risk reduction. Presenting the risk reduction of behavioural change to the individual is the most commonly used behavioural change technique in the literature. (4) Framing. Describing the consequences of performing or not performing an action, presented as a gain versus a loss,18 and (5) Decision aids to help consumers participate in decisions by providing clear evidence based information on available choices. Personalized risk communication tools with these components are instrumental for making informed decisions regarding the uptake of preventive measures, adhering to risk-reducing therapy, and improving risk perception and health-related behaviours. In mental health, self-help and help-seeking are particularly important for reducing the disease burden of mental disorders. However, changing health-related behaviours to improve mental health and encouraging help-seeking have been very challenging. Based on the theoretical model and the experience of other medical disciplines (to be described below), risk communication may offer a unique opportunity for promoting behaviour change, and if successful, will make a significant contribution to depression prevention.

The principle research question of the proposed study is: Are individuals who are at high risk of having a MDE and who receive the coach-guided PDRC more likely to take self-help actions than those who receive the PDRC without coach guidance? It was hypothesized that high risk people who receive the coach-guided PDRC are more likely to take self-help actions than those receive the PDRC without coach guidance.

The secondary research questions include:

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 (Participant, Investigator, Outcomes Assessor)

盲法说明

Over the study period, investigators will be blinded to participants' group status. The survey firm interviewers who conduct randomization, will not be involved in follow-up interviews. The interviewers who conduct the follow-up interviews in Ottawa will not have access to participants' group status. The coaches will not be involved in follow-up assessments. Given our description of study objectives, some participants may know their group status. Therefore, it is possible that some participants in the control group may try to find more information about the PDRC. At the follow-up assessments, participants will be asked if they have used any risk prediction tools over the study period. At the follow-up assessments, if participants develop a MDE, they will be encouraged to contact their family doctors and information about local mental health resources will be provided.

入排标准

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

入选标准

  • no MDE at baseline, and full remission for 2 months for those who had a past MDE (see below the question).
  • Aged 18+.
  • At high risk of MDE based on the algorithms (predicted risk of 6.5%+ for men and 11.2%+ for women).1
  • Agreement to be contacted for follow-up assessments, and
  • no language barriers to English or French. The status of remission will be assessed by the question: "In the past 2 months or longer, has your mood been much improved or back to normal AND you DIDN'T have the symptoms?"

排除标准

  • 未提供

结局指标

主要结局

Change in self-help scores

时间窗: between baseline and immediate post-intervention

Self-help behaviors measured by SSUS. The score ranges from 0 to 70 with a higher score indicating more frequent use of self-help.

次要结局

  • Non-specific psychological distress(Past 4 weeks)
  • Depression(Past 2 weeks)
  • Mental health service use(Past 3 months.)

研究者

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

JianLi Wang

Professor

University of Calgary

研究点 (2)

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