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

NCT02943876 | Completed DMC

• 1 other identifier: 10015082
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 2

Brief 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

Depression

Keywords

risk prediction; risk score; accuracy of risk perception; self-help; psychological distress

Outcome Measures

Primary Outcomes (1)

• Change in psychological distress

  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.

  baseline, 6-month, 12-month

Secondary Outcomes (2)

• Change in self-management strategy use

  Baseline, 6-month, 12-month

• Accuracy of risk perception

  baseline, 6- and 12-month follow-up assessment

Study Arms (2)

Control

NO INTERVENTION

Serves as a control group, receiving generic information about depression and self-help.

Intervention

EXPERIMENTAL

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

Interventions

personalized depression risk information OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Mathison Centre for Mental Health Research and Education

Calgary, Alberta, T2N 4Z6, Canada

Location

JianLi Wang

Calgary, Alberta, T3A 6B3, Canada

Location

Related Publications (3)

• Wang J, Eccles H, Nannarone M, Schmitz N, Patten S, Lashewicz B. Does providing personalized depression risk information lead to increased psychological distress and functional impairment? Results from a mixed-methods randomized controlled trial. Psychol Med. 2022 Aug;52(11):2071-2079. doi: 10.1017/S0033291720003955. Epub 2020 Nov 4.

  PMID: 33143794 DERIVED

• Warner E, Nannarone M, Smail-Crevier R, Manuel D, Lashewicz B, Patten S, Schmitz N, MacQueen G, Wang JL. The relationship between depression risk perception and self-help behaviours in high risk Canadians: a cross-sectional study. BMC Public Health. 2020 Jun 6;20(1):876. doi: 10.1186/s12889-020-08983-0.

  PMID: 32505198 DERIVED

• Wang J, MacQueen G, Patten S, Manuel D, Lashewicz B, Schmitz N. A randomized controlled trial to examine the impacts of disclosing personalized depression risk information on the outcomes of individuals who are at high risk of developing major depression: a research protocol. BMC Psychiatry. 2019 Sep 18;19(1):285. doi: 10.1186/s12888-019-2270-9.

  PMID: 31533691 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• JianLi Wang, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 25, 2016
• Study Start: May 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: December 31, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-05

Locations

CA (2)