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

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: Recruiting
• Conditions: Depression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed Mood
• Intervention / Treatment: Behavioral: Healthy Minds

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Corbière, PhD; Phone Number: 5574 514-987-3000; Email: corbiere.marc@uqam.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3C 3P8
      • Recruiting
      • Université du Québec a Montréal
      • Contact: Marc Corbière, PhD; Phone Number: 5574 514-987-3000; Email: corbiere.marc@uqam.ca

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	The number of days of job retention after returning to work	Baseline + 6 months ; Baseline + 12 months
Depressive symptoms	Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)	Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
Anxiety symptoms	Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)	Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
Work functioning	Endicott Work Productivity Scale (EWPS; Endicott & Nee, 1997).	Baseline + 6 months ; Baseline + 12 months
Relationship with immediate supervisor	Inventory of perceptions of supervisory style at work (Blais et al., 1991)	Baseline + 6 months ; Baseline + 12 months
Work accommodations	The Work Accommodation and Natural Support Scale (WANSS; Corbière et al., 2014).	Baseline + 6 months ; Baseline + 12 months
Return to Work Obstacles and Self-Efficacy	Return to Work Obstacles and Self-Efficacy Scale (ROSES ; Corbière et al., 2017 )	Baseline ; Baseline + 2 months
Cognitive difficulties	Online Stroop test (french version, available on https://run.pavlovia.org/FredericBr/stroop_french_v2/html/)	Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
Cognitive biases	Davos Assessment of the Cognitive Biases Scale (Bastiaens et al., 2018; van der Gaag et al., 2013)	Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

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): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Depression; Mood Disorders; Adjustment Disorders
• 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