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

Primary Purpose

Depression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed Mood

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Healthy Minds
Sponsored by
Université du Québec a Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed Mood

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Université du Québec à MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online group intervention "Healthy Minds"

Control group

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
Université du Québec a Montréal
Collaborators
Ciusss de L'Est de l'Île de Montréal, PhysioExtra, Energir
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1. Study Identification

Unique Protocol Identification Number
NCT05963308
Brief Title
Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec a Montréal
Collaborators
Ciusss de L'Est de l'Île de Montréal, PhysioExtra, Energir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed Mood

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online group intervention "Healthy Minds"
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Healthy Minds
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sustainable return-to-work
Description
The number of days of job retention after returning to work
Time Frame
Baseline + 6 months ; Baseline + 12 months
Title
Depressive symptoms
Description
Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)
Time Frame
Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
Title
Anxiety symptoms
Description
Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)
Time Frame
Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
Title
Work functioning
Description
Endicott Work Productivity Scale (EWPS; Endicott & Nee, 1997).
Time Frame
Baseline + 6 months ; Baseline + 12 months
Title
Relationship with immediate supervisor
Description
Inventory of perceptions of supervisory style at work (Blais et al., 1991)
Time Frame
Baseline + 6 months ; Baseline + 12 months
Title
Work accommodations
Description
The Work Accommodation and Natural Support Scale (WANSS; Corbière et al., 2014).
Time Frame
Baseline + 6 months ; Baseline + 12 months
Title
Return to Work Obstacles and Self-Efficacy
Description
Return to Work Obstacles and Self-Efficacy Scale (ROSES ; Corbière et al., 2017 )
Time Frame
Baseline ; Baseline + 2 months
Title
Cognitive difficulties
Description
Online Stroop test (french version, available on https://run.pavlovia.org/FredericBr/stroop_french_v2/html/)
Time Frame
Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
Title
Cognitive biases
Description
Davos Assessment of the Cognitive Biases Scale (Bastiaens et al., 2018; van der Gaag et al., 2013)
Time Frame
Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Corbière, PhD
Phone
514-987-3000
Ext
5574
Email
corbiere.marc@uqam.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Corbière, PhD
Organizational Affiliation
Université du Québec a Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université du Québec à Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3C 3P8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Corbière, PhD
Phone
514-987-3000
Ext
5574
Email
corbiere.marc@uqam.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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