A Pilot Study of the Effect of Personalized Depression Risk Communication

NCT04519892 | Completed

• 1 other identifier: pilot#1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Psychological Distress

Keywords

risk communication; self-help; mental health service use

Outcome Measures

Primary Outcomes (1)

• Change in self-help scores

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

  between baseline and immediate post-intervention

Secondary Outcomes (3)

• Non-specific psychological distress

  Past 4 weeks

• Depression

  Past 2 weeks

• Mental health service use

  Past 3 months.

Study Arms (2)

Receiving PDRC and coach guidance

EXPERIMENTAL

Intervention group: Receiving PDRC + coach guidance.

Other: PDRC; Other: Coach guidance

Receiving PDRC without coach guidance

ACTIVE COMPARATOR

Control group: Receiving PDRC only.

Other: PDRC

Interventions

PDRC OTHER

Personalized depression risk communication.

Receiving PDRC and coach guidance; Receiving PDRC without coach guidance

Coach guidance OTHER

Coaching service to guide the understanding of PDRC and answer questions.

Receiving PDRC and coach guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?"

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Ottawa Institute of Mental Health Research

Ottawa, Ontario, K1Z7k4, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jianli Wang

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a randomized controlled trial with two arms. After screening and baseline assessment, participants will be randomized into: (1) Control group: Receiving PDRC only, and (2) Intervention group: Receiving PDRC + coach guidance. The trial was designed to compare the costs and effectiveness between the groups to inform future implementation. The randomization will be conducted in males and females separately because the MVRPs are sex-specific and the thresholds of high-risk differ by sex. Participants will be assessed at baseline and 3-month.

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 20, 2020
• Study Start: November 13, 2020
• Primary Completion: December 31, 2021
• Study Completion: May 1, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)