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

Adjustment Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963308
• Other study ID #: 2023-0SYA-316461
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Adjustment Disorder With Anxious Mood
• Adjustment Disorders
• Anxiety Disorders
• Depression Anxiety Disorder

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