Depression Anxiety DisorderNCT05963308
Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention
A study testing Healthy Minds in people with Depression Anxiety Disorder and Adjustment Disorders, run by Université du Québec a Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression Anxiety Disorder, Adjustment Disorders, Adjustment Disorder With Anxious Mood
- What is being tested?
- Healthy Minds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Inability to communicate in French
- Have a known organic disorder
- Have already received CBT-type intervention (group or individual)
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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
- Being tested
- Healthy Minds
- Medical subject headings
- Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy MindsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online group intervention "Healthy Minds" | Experimental | Not described Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustainable return-to-work
The number of days of job retention after returning to work
Measured: Baseline; follow-ups at six months and 12 months
Depressive symptoms
Patient Health Questionnaire for depression (PHQ-9)
Measured: Baseline; follow-ups at two months, six months and 12 months
Anxiety symptoms
Generalized Anxiety Disorder Scale (GAD-7)
Measured: Baseline ; follow-ups at two months, six months and 12 months
Work functioning
Endicott Work Productivity Scale (EWPS)
Measured: Follow-ups at six months and 12 months
Relationship with immediate supervisor
Inventory of perceptions of supervisory style at work
Measured: Follow-ups at six months and 12 months
Work accommodations
The Work Accommodation and Natural Support Scale (WANSS).
Measured: Follow-ups at six months and 12 months
Return to Work Obstacles and Self-Efficacy
Return to Work Obstacles and Self-Efficacy Scale (ROSES)
Measured: Baseline ; Follow-ups at two months
Cognitive difficulties
Online Stroop test (French version)
Measured: Baseline ; Follow-ups at two months, six months and 12 months
Cognitive biases
Davos Assessment of the Cognitive Biases Scale
Measured: Baseline ; Follow-ups at two months, six months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start6 Mar 2023
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec a Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- PhysioExtra, Energir, Ciusss de L'Est de l'Île de Montréal
- Responsible party
- Principal investigator, Marc Corbière, Université du Québec a Montréal
- Investigators
- Marc Corbière, PhD, Principal investigator, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963308
- Sponsor's protocol ID
- 2023-0SYA-316461
- Status last verified
- May 2026
- First submitted
- 18 Jul 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05963308
- Acronym / sponsor ID
- 2023-0SYA-316461
- Conditions
- Depression Anxiety Disorder, Adjustment Disorders, Adjustment Disorder With Anxious Mood, Adjustment Disorder With Depressed Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Collaborators
- PhysioExtra, Energir, Ciusss de L'Est de l'Île de Montréal
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to communicate in French
- Have a known organic disorder
- Have already received CBT-type intervention (group or individual)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy MindsThe 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. | Behavioural | Online group intervention "Healthy Minds" |
Primary outcome
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
Depressive symptoms
Time frame: Baseline; follow-ups at two months, six months and 12 months
Patient Health Questionnaire for depression (PHQ-9)
Anxiety symptoms
Time frame: Baseline ; follow-ups at two months, six months and 12 months
Generalized Anxiety Disorder Scale (GAD-7)
Work functioning
Time frame: Follow-ups at six months and 12 months
Endicott Work Productivity Scale (EWPS)
Relationship with immediate supervisor
Time frame: Follow-ups at six months and 12 months
Inventory of perceptions of supervisory style at work
Work accommodations
Time frame: Follow-ups at six months and 12 months
The Work Accommodation and Natural Support Scale (WANSS).
Return to Work Obstacles and Self-Efficacy
Time frame: Baseline ; Follow-ups at two months
Return to Work Obstacles and Self-Efficacy Scale (ROSES)
Cognitive difficulties
Time frame: Baseline ; Follow-ups at two months, six months and 12 months
Online Stroop test (French version)
Cognitive biases
Time frame: Baseline ; Follow-ups at two months, six months and 12 months
Davos Assessment of the Cognitive Biases Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Depression Anxiety Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Corbière, PhD principal investigator
Université du Québec a Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds in people with Depression Anxiety Disorder and Adjustment Disorders, run by Université du Québec a Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustainable return-to-work (time frame: Baseline; follow-ups at six months and 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.