ClinicalTrials.gg
CompletedNCT05963308Updated Jun 1, 2026

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

An interventional study of Healthy Minds in Depression Anxiety Disorder, Adjustment Disorders and Adjustment Disorder With Anxious Mood, sponsored by Université du Québec a Montréal. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Université du Québec a Montréal · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2023, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

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

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03

In context

Adjustment Disorders

63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.

This study's enrollment of 123 is above the median of 100 across 52 interventional studies indexed under Adjustment Disorders.

Browse Adjustment Disorders studies →

Lead sponsor

Université du Québec a Montréal is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Inability to communicate in French
  • Have a known organic disorder
  • Have already received CBT-type intervention (group or individual)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Online group intervention "Healthy Minds"

    Behavioral: Healthy Minds

  • No intervention
    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)

Interventions

  • BehavioralHealthy 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.

06

What researchers measure

Primary outcomes

  1. Sustainable return-to-work

    The number of days of job retention after returning to work

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

  2. Depressive symptoms

    Patient Health Questionnaire for depression (PHQ-9)

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

  3. Anxiety symptoms

    Generalized Anxiety Disorder Scale (GAD-7)

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

  4. Work functioning

    Endicott Work Productivity Scale (EWPS)

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

  5. Relationship with immediate supervisor

    Inventory of perceptions of supervisory style at work

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

  6. Work accommodations

    The Work Accommodation and Natural Support Scale (WANSS).

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

  7. Return to Work Obstacles and Self-Efficacy

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

    Time frame: Baseline ; Follow-ups at two months

  8. Cognitive difficulties

    Online Stroop test (French version)

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

  9. Cognitive biases

    Davos Assessment of the Cognitive Biases Scale

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

07

Study locations

1 site
  • Université du Québec à Montréal
    Montreal, Quebec H3C 3P8, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Mar 2026, 35 months.

Of 25 interventional studies with no phase under Adjustment Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2023
First posted
Jul 27, 2023
StartActual
Mar 6, 2023
Primary completionActual
Mar 1, 2026
CompletionActual
Mar 1, 2026
Last update
Jun 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05963308
Lead sponsor
Université du Québec a Montréal
Collaborators
PhysioExtra, Energir, Ciusss de L'Est de l'Île de Montréal
Responsible party
Marc Corbière (Full Professor, Université du Québec a Montréal) — Principal investigator
First posted
Jul 27, 2023
Start date
Mar 6, 2023
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026
Last update
Jun 1, 2026

Study contacts

Marc Corbière, PhD
principal investigator · Université du Québec a Montréal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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