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Completed

NCT Number: NCT05963308

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

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.

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Key information

Conditions

Depression Anxiety Disorder Adjustment Disorder With Anxious Mood Adjustment Disorder With Depressed Mood Adjustment Disorders Mental Disorders Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université du Québec à Montréal

Montreal, Quebec, H3C 3P8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Sustainable return-to-work

    Time frame: Baseline; follow-ups at six months and 12 months

    The number of days of job retention after returning to work

  2. Depressive symptoms

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

    Patient Health Questionnaire for depression (PHQ-9)

  3. Anxiety symptoms

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

    Generalized Anxiety Disorder Scale (GAD-7)

  4. Work functioning

    Time frame: Follow-ups at six months and 12 months

    Endicott Work Productivity Scale (EWPS)

  5. Relationship with immediate supervisor

    Time frame: Follow-ups at six months and 12 months

    Inventory of perceptions of supervisory style at work

  6. Work accommodations

    Time frame: Follow-ups at six months and 12 months

    The Work Accommodation and Natural Support Scale (WANSS).

  7. Return to Work Obstacles and Self-Efficacy

    Time frame: Baseline ; Follow-ups at two months

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

  8. Cognitive difficulties

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

    Online Stroop test (French version)

  9. Cognitive biases

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

    Davos Assessment of the Cognitive Biases Scale

Sponsors and collaborators

Lead sponsor

Université du Québec a Montréal

Other

Collaborators

  • Ciusss de L'Est de l'Île de Montréal
  • Energir
  • PhysioExtra

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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