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Clinical Trials/NCT05963308
NCT05963308
Recruiting
Not Applicable

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

Université du Québec a Montréal1 site in 1 country80 target enrollmentMarch 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression Anxiety Disorder
Sponsor
Université du Québec a Montréal
Enrollment
80
Locations
1
Primary Endpoint
Sustainable return-to-work
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 6, 2023
End Date
March 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Université du Québec a Montréal
Responsible Party
Principal Investigator
Principal Investigator

Marc Corbière

Full Professor

Université du Québec a Montréal

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

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

Relationship with immediate supervisor

Time Frame: Follow-ups at six months and 12 months

Inventory of perceptions of supervisory style at work

Depressive symptoms

Time Frame: Baseline; follow-ups at two months, six months and 12 months

Patient Health Questionnaire for depression (PHQ-9)

Return to Work Obstacles and Self-Efficacy

Time Frame: Baseline ; Follow-ups at two months

Return to Work Obstacles and Self-Efficacy Scale (ROSES)

Work functioning

Time Frame: Follow-ups at six months and 12 months

Endicott Work Productivity Scale (EWPS)

Cognitive difficulties

Time Frame: Baseline ; Follow-ups at two months, six months and 12 months

Online Stroop test (French version)

Anxiety symptoms

Time Frame: Baseline ; follow-ups at two months, six months and 12 months

Generalized Anxiety Disorder Scale (GAD-7)

Work accommodations

Time Frame: Follow-ups at six months and 12 months

The Work Accommodation and Natural Support Scale (WANSS).

Cognitive biases

Time Frame: Baseline ; Follow-ups at two months, six months and 12 months

Davos Assessment of the Cognitive Biases Scale

Study Sites (1)

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