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

Sponsor
Université du Québec a Montréal (Other)
Overall Status
Recruiting
CT.gov ID
NCT05963308
Collaborator
Ciusss de L'Est de l'Île de Montréal (Other), PhysioExtra (Other), Energir (Other)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Minds
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention
Actual Study Start Date :
Mar 6, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Sustainable return-to-work [Baseline + 6 months ; Baseline + 12 months]

    The number of days of job retention after returning to work

  2. Depressive symptoms [Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months]

    Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)

  3. Anxiety symptoms [Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months]

    Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)

  4. Work functioning [Baseline + 6 months ; Baseline + 12 months]

    Endicott Work Productivity Scale (EWPS; Endicott & Nee, 1997).

  5. Relationship with immediate supervisor [Baseline + 6 months ; Baseline + 12 months]

    Inventory of perceptions of supervisory style at work (Blais et al., 1991)

  6. Work accommodations [Baseline + 6 months ; Baseline + 12 months]

    The Work Accommodation and Natural Support Scale (WANSS; Corbière et al., 2014).

  7. Return to Work Obstacles and Self-Efficacy [Baseline ; Baseline + 2 months]

    Return to Work Obstacles and Self-Efficacy Scale (ROSES ; Corbière et al., 2017 )

  8. Cognitive difficulties [Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months]

    Online Stroop test (french version, available on https://run.pavlovia.org/FredericBr/stroop_french_v2/html/)

  9. Cognitive biases [Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months]

    Davos Assessment of the Cognitive Biases Scale (Bastiaens et al., 2018; van der Gaag et al., 2013)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Université du Québec à Montréal Montréal Quebec Canada H3C 3P8

Sponsors and Collaborators

  • Université du Québec a Montréal
  • Ciusss de L'Est de l'Île de Montréal
  • PhysioExtra
  • Energir

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marc Corbière, Full Professor, Université du Québec a Montréal
ClinicalTrials.gov Identifier:
NCT05963308
Other Study ID Numbers:
  • 2023-0SYA-316461
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023