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The Impact of Disclosing Personalized Depression Risk Information on High-risk Individuals' Outcomes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by University of Calgary
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
JianLi Wang, University of Calgary
ClinicalTrials.gov Identifier:
NCT02943876
First received: October 21, 2016
Last updated: October 25, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Depression
Other: personalized depression risk information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Disclosing Personalized Depression Risk Information on High-risk Individuals' Outcomes

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change in psychological distress [ Time Frame: baseline, 6-month, 12-month ]
    Psychological distress will be measured by the Non-Specific Psychological Distress (K10), a 10-item screening scale intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period.


Secondary Outcome Measures:
  • Change in self-management strategy use [ Time Frame: Baseline, 6-month, 12-month ]
    It will be measured by self-management strategy use scale (SSUS) was developed and validated by Morgan and Jorm

  • Accuracy of risk perception [ Time Frame: baseline, 6- and 12-month follow-up assessment ]
    "How likely are you to get depression in the next 4 years?" The answer can range from 0 to 100, where 0=certain not to happen and 100=certain to happen


Estimated Enrollment: 700
Study Start Date: February 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Serves as a control group, receiving generic information about depression and self-help.
Experimental: Intervention
Serves as an intervention group, receiving personalized depression risk information determined by the sex-specific risk calculators, and generic information about depression and self-help.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • did not have a MDE at baseline,
  • aged 18+ years old,
  • at high risk of MDE based on the algorithms (predicted risk of 6.5%+ for men and of 11.2%+ for women),
  • agreement to be contacted for follow-up assessments, and
  • no language barriers to English or French.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02943876

Contacts
Contact: JianLi Wang, PhD 403-210-8653 jlwang@ucalgary.ca
Contact: Erin Jones 402-210-6839 emjones@ucalgary.ca

Locations
Canada, Alberta
JianLi Wang Not yet recruiting
Calgary, Alberta, Canada, T3A 6B3
Contact: JianLi Wang, PhD    4039913738    jlwang@ucalgary.ca   
Contact: Erin Jones    403-2106839    emjones@ucalgary.ca   
Sub-Investigator: Scott Patten, MD, PhD         
Sub-Investigator: Glenda MacQueen, MD         
Sub-Investigator: Bonnie Lashewicz, PhD         
Sub-Investigator: Douglas Manuel, MD, PhD         
Sub-Investigator: Norbert Schmitz, PhD         
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: JianLi Wang, PhD University of Calgary
  More Information

Responsible Party: JianLi Wang, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02943876     History of Changes
Other Study ID Numbers: 10015082
Study First Received: October 21, 2016
Last Updated: October 25, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Calgary:
risk prediction
risk score
accuracy of risk perception
self-help
psychological distress

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 24, 2017