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

NCT ID: NCT05963308

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2025-03-01

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Online group intervention "Healthy Minds"

Group Type EXPERIMENTAL

Healthy Minds

Intervention Type 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.

Control group

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role collaborator

PhysioExtra

UNKNOWN

Sponsor Role collaborator

Energir

UNKNOWN

Sponsor Role collaborator

Université du Québec a Montréal

OTHER

Sponsor Role lead

Responsible Party

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Marc Corbière

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc Corbière, PhD

Role: PRINCIPAL_INVESTIGATOR

Université du Québec a Montréal

Locations

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Université du Québec à Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Marc Corbière, PhD

Role: CONTACT

514-987-3000 ext. 5574

Facility Contacts

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Marc Corbière, PhD

Role: primary

514-987-3000 ext. 5574

Other Identifiers

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2023-0SYA-316461

Identifier Type: -

Identifier Source: org_study_id

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