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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Healthy Minds


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online group intervention Healthy Minds<br> | Behavioral: Healthy Minds<br>* 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.<br>|
| No Intervention: Control group<br>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?
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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 |