Clinical trial NCT05963308: Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression Anxiety Disorder
Adjustment Disorders
Adjustment Disorder With Anxious Mood
Adjustment Disorder With Depressed Mood
Lead sponsor: Université du Québec a Montréal
Sponsor class: OTHER
Collaborators: name: Ciusss de L'Est de l'Île de Montréal
name: PhysioExtra
name: Energir
First posted: 2023-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sustainable return-to-work
timeFrame: Baseline; follow-ups at six months and 12 months
measure: Depressive symptoms
timeFrame: Baseline; follow-ups at two months, six months and 12 months
measure: Anxiety symptoms
timeFrame: Baseline ; follow-ups at two months, six months and 12 months
measure: Work functioning
timeFrame: Follow-ups at six months and 12 months
measure: Relationship with immediate supervisor
timeFrame: Follow-ups at six months and 12 months
measure: Work accommodations
timeFrame: Follow-ups at six months and 12 months
measure: Return to Work Obstacles and Self-Efficacy
timeFrame: Baseline ; Follow-ups at two months
measure: Cognitive difficulties
timeFrame: Baseline ; Follow-ups at two months, six months and 12 months
measure: Cognitive biases
timeFrame: Baseline ; Follow-ups at two months, six months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Université du Québec à Montréal
state: Quebec
Study officials:
affiliation: Université du Québec a Montréal
name: Marc Corbière, PhD
role: PRINCIPAL_INVESTIGATOR
References: