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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05963308
Other study ID # 2023-0SYA-316461
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 6, 2023
Est. completion date March 1, 2025

Study information

Verified date May 2024
Source Université du Québec a Montréal
Contact Marc Corbière, PhD
Phone 514-987-3000
Email corbiere.marc@uqam.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Université du Québec à Montréal Montréal Quebec

Sponsors (4)

Lead Sponsor Collaborator
Université du Québec a Montréal Ciusss de L'Est de l'Île de Montréal, Energir, PhysioExtra

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sustainable return-to-work The number of days of job retention after returning to work Baseline; follow-ups at six months and 12 months
Primary Depressive symptoms Patient Health Questionnaire for depression (PHQ-9) Baseline; follow-ups at two months, six months and 12 months
Primary Anxiety symptoms Generalized Anxiety Disorder Scale (GAD-7) Baseline ; follow-ups at two months, six months and 12 months
Primary Work functioning Endicott Work Productivity Scale (EWPS) Follow-ups at six months and 12 months
Primary Relationship with immediate supervisor Inventory of perceptions of supervisory style at work Follow-ups at six months and 12 months
Primary Work accommodations The Work Accommodation and Natural Support Scale (WANSS). Follow-ups at six months and 12 months
Primary Return to Work Obstacles and Self-Efficacy Return to Work Obstacles and Self-Efficacy Scale (ROSES) Baseline ; Follow-ups at two months
Primary Cognitive difficulties Online Stroop test (French version) Baseline ; Follow-ups at two months, six months and 12 months
Primary Cognitive biases Davos Assessment of the Cognitive Biases Scale Baseline ; Follow-ups at two months, six months and 12 months
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