Common Mental DisorderPRATICAdrNCT06397326
Sustainable and Healthy Return-to-Work Program - PRATICAdr 2.0
A study testing Return to work coordinator + PRATICAdr 2.0 and Return to work coordinator only in people with Common Mental Disorder, run by Université du Québec a Montréal at 1 site in Canada.
Trial summary
This study aims to assess the effectiveness of PRATICAdr 2.0, a web application facilitated by a Return-to-Work Coordinator (RTW-C), with a focus on reducing sick leave duration and preventing relapse in individuals with CMDs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Common Mental Disorder
- What is being tested?
- Return to work coordinator + PRATICAdr 2.0 and Return to work coordinator only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2024to 15 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sick leave due to Common mental disorder (i.e. depression, anxiety, adjustment disorder, burnout)
- Sick leave duration (from 1 to 3 months)
- Member of participating unions in the large health organization
Who cannot join
- Inability to communicate in French
- Have a known organic disorder
- Have a professional dirsorder (CNESST)
- Have experienced previous sick leaves due to Common mental disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Montréal (UQAM), Department of Education and Pedagogy, Career Counselling
Montreal, Quebec, H3C 3P8
About this study
Official title: Sustainable and Healthy Return-to-Work Program for Employees of Large Healthcare Organizations - PRATICAdr 2.0
This study aims to assess the effectiveness of PRATICAdr 2.0, a web application facilitated by a Return-to-Work Coordinator (RTW-C), with a focus on reducing sick leave duration and preventing relapse in individuals with CMDs. PRATICAdr 2.0 designed to enhance collaboration among Return-to-Work (RTW) stakeholders and provide systematic support throughout the RTW process, is evaluated in a randomized control trial (RCT). As part of the RCT, a total of 80 sick leave employees from 4 large public health organizations (n=80, 40 from the experimental group and 40 from the control group) will be recruited. The control group receives usual services offered by a RTW-C to sick leave employees, while the experimental group receives RTW-C services plus the use of PRATICAdr 2.0.
Read the detailed description
Common mental disorders (CMDs) are highly prevalent in workplace settings, and have become a significant public health challenge. This study aims to assess the effectiveness of PRATICAdr 2.0, a web application facilitated by a Return-to-Work Coordinator (RTW-C), with a focus on reducing sick leave duration and preventing relapse in individuals with CMDs. PRATICAdr 2.0 designed to enhance collaboration among Return-to-Work (RTW) stakeholders and provide systematic support throughout the RTW process, is evaluated in a randomized control trial (RCT). As part of the RCT, a total of 80 sick leave employees from 4 large public health organizations (n=80, 40 from the experimental group and 40 from the control group) will be recruited. The control group receives usual services offered by a RTW-C to sick leave employees, while the experimental group receives RTW-C services plus the use of PRATICAdr 2.0. Participants will be randomly assigned to either the PRATICAdr 2.0 experimental group or the control group using computerized stratified randomization based on age, site, and sex (sealed envelope method). Participants will complete a series of online questionnaires at several following time points. Survival analyses were used to compare sick leave durations and relapses between the experimental group (PRATICAdr with RTW-C), and control groups (RTW-C only). Mixed linear models were used to observe changes in clinical symptoms over time, especially for the experimental group.
- Conditions
- Common Mental Disorder
- Being tested
- Return to work coordinator + PRATICAdr 2.0, Return to work coordinator only
- Keywords
- Return to work, Sick leave duration, Relapses, Clinical symptoms
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return to work coordinator + PRATICAdr 2.0Behavioural
The Return to work coordinator (RTW-C) uses PRATICAdr. 2.0 (web application).
Return to work coordinator onlyBehavioural
The Return to work coordinator (RTW-C) intervenes on employees on sick leave as usual
| Study group | Role | What they receive |
|---|---|---|
| Return to work coordinator + PRATICAdr 2.0 | Experimental | The primary objective of the Return to work coordinator (RTW-C) is to coordinate, plan, and promote sustainable RTW for employees on sick leave.The RTW-C is responsible for assessing employee functioning while exploring barriers to RTW and available resources to develop a RTW plan. Also, RTW-C enhance communication and collaboration among stakeholders involved in the RTW process.
In this arm, the RTW-C uses PRATICAdr 2.0, a web application including key features (e.g., Facilitation of collaboration among multiple RTW stakeholders across healthcare, enterprise, and insurance sectors; Integration of each stakeholder's action into the sick leave employee's RTW process; sequential process aligned with the three phases of the RTW, inclusion of tools). Receives: Behavioral: Return to work coordinator + PRATICAdr 2.0 |
| Return to work coordinator only | Sham comparator | The primary objective of the Return to work coordinator (RTW-C) is to coordinate, plan, and promote sustainable RTW for employees on sick leave.The RTW-C is responsible for assessing employee functioning while exploring barriers to RTW and available resources to develop a RTW plan. Also, RTW-C enhance communication and collaboration among stakeholders involved in the RTW process.
In this arm, the RTW-C does not use PRATICAdr 2.0. Receives: Behavioral: Return to work coordinator only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick leave duration
The number of days during the sick leave
Measured: through study completion, an average of 2 years
Relapses
Number of relapses after returning to work
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
Depressive symptoms
Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)
Measured: through study completion, an average of 2 years
Anxiety symptoms
Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)
Measured: through study completion, an average of 2 years
Return to Work Obstacles and Self-Efficacy
Return to Work Obstacles and Self-Efficacy Scale (ROSES ; Corbière et al., 2017 )
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start6 May 2024
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Mental 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
- Model description
- Two groups: Experimental: Return to work coordinator + PRATICAdr 2.0 Control group: Return to work coordinator only
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec a Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre intégré de santé et de services sociaux (CISSS) de la Gaspésie, Centre intégré de santé et de services sociaux (CISSS) de Laval, Centre hospitalier de l'Université de Montréal (CHUM), Centre intégré universitaire de santé et de services sociaux du Centre Ouest de Montréal
- Responsible party
- Principal investigator, Marc Corbière, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397326
- Sponsor's protocol ID
- MSSS-23-RH-00599
- Acronym
- PRATICAdr
- Status last verified
- May 2026
- First submitted
- 5 Apr 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable and Healthy Return-to-Work Program for Employees of Large Healthcare Organizations - PRATICAdr 2.0
- ClinicalTrials.gov ID
- NCT06397326
- Acronym / sponsor ID
- PRATICAdr / MSSS-23-RH-00599
- Conditions
- Common Mental Disorder
- Keywords
- Return to work, Sick leave duration, Relapses, Clinical symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Collaborators
- Centre intégré de santé et de services sociaux (CISSS) de la Gaspésie, Centre intégré de santé et de services sociaux (CISSS) de Laval, Centre hospitalier de l'Université de Montréal (CHUM), Centre intégré universitaire de santé et de services sociaux du Centre Ouest de Montréal
- Study start
- 6 May 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 2 May 2024 (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.
This study aims to assess the effectiveness of PRATICAdr 2.0, a web application facilitated by a Return-to-Work Coordinator (RTW-C), with a focus on reducing sick leave duration and preventing relapse in individuals with CMDs. PRATICAdr 2.0 designed to enhance collaboration among Return-to-Work (RTW) stakeholders and provide systematic support throughout the RTW process, is evaluated in a randomized control trial (RCT). As part of the RCT, a total of 80 sick leave employees from 4 large public health organizations (n=80, 40 from the experimental group and 40 from the control group) will be recruited. The control group receives usual services offered by a RTW-C to sick leave employees, while the experimental group receives RTW-C services plus the use of PRATICAdr 2.0.
Detailed description
Common mental disorders (CMDs) are highly prevalent in workplace settings, and have become a significant public health challenge. This study aims to assess the effectiveness of PRATICAdr 2.0, a web application facilitated by a Return-to-Work Coordinator (RTW-C), with a focus on reducing sick leave duration and preventing relapse in individuals with CMDs. PRATICAdr 2.0 designed to enhance collaboration among Return-to-Work (RTW) stakeholders and provide systematic support throughout the RTW process, is evaluated in a randomized control trial (RCT). As part of the RCT, a total of 80 sick leave employees from 4 large public health organizations (n=80, 40 from the experimental group and 40 from the control group) will be recruited. The control group receives usual services offered by a RTW-C to sick leave employees, while the experimental group receives RTW-C services plus the use of PRATICAdr 2.0. Participants will be randomly assigned to either the PRATICAdr 2.0 experimental group or the control group using computerized stratified randomization based on age, site, and sex (sealed envelope method). Participants will complete a series of online questionnaires at several following time points. Survival analyses were used to compare sick leave durations and relapses between the experimental group (PRATICAdr with RTW-C), and control groups (RTW-C only). Mixed linear models were used to observe changes in clinical symptoms over time, especially for the experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: Experimental: Return to work coordinator + PRATICAdr 2.0 Control group: Return to work coordinator only
| Arm | Type | Receives |
|---|---|---|
| Return to work coordinator + PRATICAdr 2.0 | Experimental | Behavioral: Return to work coordinator + PRATICAdr 2.0The primary objective of the Return to work coordinator (RTW-C) is to coordinate, plan, and promote sustainable RTW for employees on sick leave.The RTW-C is responsible for assessing employee functioning while exploring barriers to RTW and available resources to develop a RTW plan. Also, RTW-C enhance communication and collaboration among stakeholders involved in the RTW process. In this arm, the RTW-C uses PRATICAdr 2.0, a web application including key features (e.g., Facilitation of collaboration among multiple RTW stakeholders across healthcare, enterprise, and insurance sectors; Integration of each stakeholder's action into the sick leave employee's RTW process; sequential process aligned with the three phases of the RTW, inclusion of tools). |
| Return to work coordinator only | Sham comparator | Behavioral: Return to work coordinator onlyThe primary objective of the Return to work coordinator (RTW-C) is to coordinate, plan, and promote sustainable RTW for employees on sick leave.The RTW-C is responsible for assessing employee functioning while exploring barriers to RTW and available resources to develop a RTW plan. Also, RTW-C enhance communication and collaboration among stakeholders involved in the RTW process. In this arm, the RTW-C does not use PRATICAdr 2.0. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sick leave due to Common mental disorder (i.e. depression, anxiety, adjustment disorder, burnout)
- Sick leave duration (from 1 to 3 months)
- Member of participating unions in the large health organization
Key exclusion criteria (4 listed)
- Inability to communicate in French
- Have a known organic disorder
- Have a professional dirsorder (CNESST)
- Have experienced previous sick leaves due to Common mental disorder
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 |
|---|---|---|
| Return to work coordinator + PRATICAdr 2.0The Return to work coordinator (RTW-C) uses PRATICAdr. 2.0 (web application). | Behavioural | Return to work coordinator + PRATICAdr 2.0 |
| Return to work coordinator onlyThe Return to work coordinator (RTW-C) intervenes on employees on sick leave as usual | Behavioural | Return to work coordinator only |
Primary outcome
Sick leave duration
Time frame: through study completion, an average of 2 years
The number of days during the sick leave
Relapses
Time frame: through study completion, an average of 2 years
Number of relapses after returning to work
3 secondary outcomes
Depressive symptoms
Time frame: through study completion, an average of 2 years
Anxiety symptoms
Time frame: through study completion, an average of 2 years
Return to Work Obstacles and Self-Efficacy
Time frame: through study completion, an average of 2 years
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 29 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Return to work coordinator + PRATICAdr 2.0 and Return to work coordinator only in people with Common Mental Disorder, 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 4 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 29 May 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. Some participants in this study may receive a placebo. 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?
Sick leave duration (time frame: through study completion, an average of 2 years). The study lists 2 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 29 May 2026.