Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention

May 27, 2026 updated by: Marc Corbière, Université du Québec a Montréal

The purpose of this clinical trial is to evaluate the impact of an online group intervention called Healthy Minds in facilitating a sustainable return to work for individuals with a mood disorder. The study aims to answer the following key questions :

  • Does receiving the Healthy Minds online intervention lead to a more sustainable return to work compared to not receiving the intervention?
  • Are the health outcomes (e.g., depressive symptoms) and work-related outcomes (e.g., work functioning) of individuals who receive the Healthy Minds online intervention better than those who do not receive the intervention in the year following the intervention?

Both experimental and control participants will be recruited at baseline while on sick leave (expected to return to work in less than one month) or recently returned to work (less than one month). Participants will complete a series of online questionnaires at the following time points :

  • Baseline
  • First follow-up (2 months after baseline)
  • Second follow-up (6 months after baseline)
  • Third follow-up (12 months after baseline)

The questionnaires will cover the following areas :

  • Sociodemographic and biopsychosocial factors
  • Symptoms associated with the primary mood disorder
  • Cognitive difficulties and biaises
  • Self-efficacy related to return to work
  • Work accommodations and natural supports
  • Relationship with immediate supervisor
  • Work functioning
  • Return to work time (number of days away from work)

Experimental participants will participate in the 2-month online Healthy Minds group intervention (cohort of 5 participants) between the baseline assessment and the first follow-up. The intervention consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3C 3P8
        • Université du Québec a Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be in the process of returning to work after depression, anxiety disorder, adjustment disorder (with depressed mood, or anxious mood).

or

  • Been back for less than a month

Exclusion Criteria:

  • Inability to communicate in French
  • Have a known organic disorder
  • Have already received CBT-type intervention (group or individual)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online group intervention "Healthy Minds"
Behavioral: Healthy Minds

The group intervention (approximately 5 participants per group, 8 groups) is facilitated by two clinicians and consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective:

Week1: Coping with work stress at work W2 and W3: Recognizing and modifying my dysfunctional beliefs linked to work W4: Overcoming obstacles linked to work functioning and maintaining work W5: To put in place needed work accommodations with the support of the immediate supervisor W6: My strengths and competencies related to work W7: Accepting criticism and asserting myself appropriately W7: My strengths and related skills W8: My best coping strategies for work Both intervention and control participants receive their standard individualized care from their clinician. However, for the experimental participants, the Healthy Minds intervention is an added component to their regular care.
No Intervention: Control group

Like the intervention group, the control group will complete an online set of questionnaires at the following time points:

  • Baseline
  • First follow-up (2 months after baseline)
  • Second follow-up (6 months after baseline)
  • Third follow-up (12 months after baseline)

The questionnaires will cover the following domains:

  • Sociodemographic and biopsychosocial factors
  • Symptoms associated with the primary mood disorder
  • Cognitive difficulties and distortions
  • Self-efficacy in relation to returning to work
  • Work accommodations and natural supports
  • Relationship with immediate supervisor
  • Work functioning
  • Return-to-work time (number of days away from work)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustainable return-to-work
Time Frame: Baseline; follow-ups at six months and 12 months
The number of days of job retention after returning to work
Baseline; follow-ups at six months and 12 months
Depressive symptoms
Time Frame: Baseline; follow-ups at two months, six months and 12 months
Patient Health Questionnaire for depression (PHQ-9)
Baseline; follow-ups at two months, six months and 12 months
Anxiety symptoms
Time Frame: Baseline ; follow-ups at two months, six months and 12 months
Generalized Anxiety Disorder Scale (GAD-7)
Baseline ; follow-ups at two months, six months and 12 months
Work functioning
Time Frame: Follow-ups at six months and 12 months
Endicott Work Productivity Scale (EWPS)
Follow-ups at six months and 12 months
Relationship with immediate supervisor
Time Frame: Follow-ups at six months and 12 months
Inventory of perceptions of supervisory style at work
Follow-ups at six months and 12 months
Work accommodations
Time Frame: Follow-ups at six months and 12 months
The Work Accommodation and Natural Support Scale (WANSS).
Follow-ups at six months and 12 months
Return to Work Obstacles and Self-Efficacy
Time Frame: Baseline ; Follow-ups at two months
Return to Work Obstacles and Self-Efficacy Scale (ROSES)
Baseline ; Follow-ups at two months
Cognitive difficulties
Time Frame: Baseline ; Follow-ups at two months, six months and 12 months
Online Stroop test (French version)
Baseline ; Follow-ups at two months, six months and 12 months
Cognitive biases
Time Frame: Baseline ; Follow-ups at two months, six months and 12 months
Davos Assessment of the Cognitive Biases Scale
Baseline ; Follow-ups at two months, six months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec a Montréal

Collaborators

Ciusss de L'Est de l'Île de Montréal
PhysioExtra
Energir

Investigators

  • Principal Investigator: Marc Corbière, PhD, Université du Québec a Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0SYA-316461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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