Sustainable and Healthy Return-to-Work Program - PRATICAdr 2.0

Common Mental Disorder Clinical Trial

— PRATICAdr  

Official title:

Sustainable and Healthy Return-to-Work Program for Employees of Large Healthcare Organizations - PRATICAdr 2.0

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397326
• Other study ID #: MSSS-23-RH-00599
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: April 15, 2026

Study information

• Verified date: April 2024
• Source: Université du Québec a Montréal
• Contact: Marc Corbière, PhD
• Phone: 514 987 3000
• Email: corbiere.marc[@]uqam.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 15, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Mental Disorder
• Mental Disorders

Intervention

Behavioral:
• Return to work coordinator + PRATICAdr 2.0
The Return to work coordinator (RTW-C) uses PRATICAdr. 2.0 (web application).
• Return to work coordinator only
The Return to work coordinator (RTW-C) intervenes on employees on sick leave as usual

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Université du Québec a Montréal	Centre hospitalier de l'Université de Montréal (CHUM), Centre intégré de santé et de services sociaux (CISSS) de la Gaspésie, Centre intégré de santé et de services sociaux (CISSS) de Laval, Centre intégré universitaire de santé et de services sociaux du Centre Ouest de Montréal

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social functioning	WHODAS	through study completion, an average of 2 years
Other	Working alliance	Working Alliance Inventory (Horvath & Greenberg, 1989; Corbière et al., 2006)	through study completion, an average of 2 years
Other	Work accommodations	Work Accommodation and Natural Support Scale (WANSS; Corbière et al., 2014)	through study completion, an average of 2 years
Other	Work recognition	Recognition by stakeholders of returning to work following a common mental disorder (RECONNECT, Corbière, Larivière, Charette-Dussault, 2021)	through study completion, an average of 2 years
Primary	Sick leave duration	The number of days during the sick leave	through study completion, an average of 2 years
Primary	Relapses	Number of relapses after returning to work	through study completion, an average of 2 years
Secondary	Depressive symptoms	Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)	through study completion, an average of 2 years
Secondary	Anxiety symptoms	Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)	through study completion, an average of 2 years
Secondary	Return to Work Obstacles and Self-Efficacy	Return to Work Obstacles and Self-Efficacy Scale (ROSES ; Corbière et al., 2017 )	through study completion, an average of 2 years