Clinical trial NCT06397326: Sustainable and Healthy Return-to-Work Program - PRATICAdr 2.0
Official title: Sustainable and Healthy Return-to-Work Program for Employees of Large Healthcare Organizations - PRATICAdr 2.0
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Common Mental Disorder
Keywords: Return to work
Sick leave duration
Relapses
Clinical symptoms
Lead sponsor: Université du Québec a Montréal
Sponsor class: OTHER
Collaborators: name: Centre intégré de santé et de services sociaux (CISSS) de la Gaspésie
name: Centre intégré de santé et de services sociaux (CISSS) de Laval
name: Centre hospitalier de l'Université de Montréal (CHUM)
name: Centre intégré universitaire de santé et de services sociaux du Centre Ouest de Montréal
First posted: 2024-05-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups:

Experimental: Return to work coordinator + PRATICAdr 2.0 Control group: Return to work coordinator only
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sick leave duration
timeFrame: through study completion, an average of 2 years
measure: Relapses
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Depressive symptoms
timeFrame: through study completion, an average of 2 years
measure: Anxiety symptoms
timeFrame: through study completion, an average of 2 years
measure: Return to Work Obstacles and Self-Efficacy
timeFrame: through study completion, an average of 2 years
Other outcomes:
measure: Social functioning
timeFrame: through study completion, an average of 2 years
measure: Working alliance
timeFrame: through study completion, an average of 2 years
measure: Work accommodations
timeFrame: through study completion, an average of 2 years
measure: Work recognition
timeFrame: through study completion, an average of 2 years
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