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

NCT05963308 | Recruiting

• 1 other identifier: 2023-0SYA-316461
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Anxiety Disorder; Adjustment Disorders; Adjustment Disorder With Anxious Mood; Adjustment Disorder With Depressed Mood

Outcome Measures

Primary Outcomes (9)

• Sustainable return-to-work

  The number of days of job retention after returning to work

  Baseline; follow-ups at six months and 12 months

• Depressive symptoms

  Patient Health Questionnaire for depression (PHQ-9)

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

• Anxiety symptoms

  Generalized Anxiety Disorder Scale (GAD-7)

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

• Work functioning

  Endicott Work Productivity Scale (EWPS)

  Follow-ups at six months and 12 months

• Relationship with immediate supervisor

  Inventory of perceptions of supervisory style at work

  Follow-ups at six months and 12 months

• Work accommodations

  The Work Accommodation and Natural Support Scale (WANSS).

  Follow-ups at six months and 12 months

• Return to Work Obstacles and Self-Efficacy

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

  Baseline ; Follow-ups at two months

• Cognitive difficulties

  Online Stroop test (French version)

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

• Cognitive biases

  Davos Assessment of the Cognitive Biases Scale

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

Study Arms (2)

Online group intervention "Healthy Minds"

EXPERIMENTAL

Behavioral: Healthy Minds

Control group

NO INTERVENTION

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)

Interventions

Healthy Minds BEHAVIORAL

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.

Online group intervention "Healthy Minds"

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Inability to communicate in French
• Have a known organic disorder
• Have already received CBT-type intervention (group or individual)

Sponsors & Collaborators

• Université du Québec a Montréal: lead
• Ciusss de L'Est de l'Île de Montréal: collaborator
• PhysioExtra: collaborator
• Energir: collaborator

Study Sites (1)

Université du Québec à Montréal

Montreal, Quebec, H3C 3P8, Canada

RECRUITING

MeSH Terms

Conditions

Adjustment Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Marc Corbière, PhD

  Université du Québec a Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Corbière, PhD

CONTACT

514-987-3000; corbiere.marc@uqam.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: March 6, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)