The Impact of Disclosing Personalized Depression Risk Information on High-risk Individuals' Outcomes
NCT02943876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 712
Last updated 2021-05-05
Summary
Major depressive episode (MDE) is one of the most prevalent and disabling form of mental illness in the general population. Despite increased mental health services and antidepressants use in the past 10 years, there has been no measurable change in the prevalence of MDE in the Canadian general population, which motivates the search for additional strategies for reducing the burden of MDE. One strategy that has been successful in the fields of oncology, cardiology and diabetes is early identification and prevention - identifying people who are at high risk and taking preventive actions to lower the risk so as to prevent symptoms from progressing into a MDE. As multivariable risk prediction algorithms are used to estimate an individual's risk (probability) of future disease, they can play an important role in the process of early identification. The proposed study stems from a project funded by an operating grant from the Canadian Institutes of Health Research (CIHR). With the CIHR support, the team developed and validated sex-specific prediction algorithms for MDE. As risk prediction is at very early stage in psychiatry and MDE is still highly stigmatized, to facilitate the future implementation of the developed risk prediction algorithms, the proposed study seeks to answer the following research questions: (1) Does disclosure of personalized depression risk information promote high-risk individuals to take preventive actions? (2) Will disclosure of personalized depression risk information negatively affect high-risk people's mental health status in terms of increased psychological distress? To answer the questions, the investigators planned to conduct a randomized controlled trial (RCT) with an embedded qualitative component. The proposed study will develop an evidence base for guiding the disclosure of personalized risk information and understanding the process of risk communication and consumer empowerment, contributing to the advancement of early prevention of MDE in Canada.
Conditions
Interventions
- OTHER
-
personalized depression risk information
The personalized depression risk information is determined by sex-specific risk prediction algorithms based on one's family history of depression, current health status, childhood traumatic experience and ongoing life stressors. The information is in the form of probability of having a major depressive episode in the next 4 years.
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
University of Calgary
lead OTHER
Principal Investigators
-
JianLi Wang, PhD · University of Calgary
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-01
- Primary Completion
- 2020-05-01
- Completion
- 2020-12-31
Countries
- Canada
Study Locations
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