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

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.

Study Overview

• Status: Completed
• Conditions: Common Mental Disorder
• Intervention / Treatment: Behavioral: Return to work coordinator + PRATICAdr 2.0; Behavioral: Return to work coordinator only

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3C 3P8
      • Université du Québec à Montréal (UQAM), Department of Education and Pedagogy, Career Counselling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Return to work coordinator + PRATICAdr 2.0; 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).	Behavioral: Return to work coordinator + PRATICAdr 2.0; The Return to work coordinator (RTW-C) uses PRATICAdr. 2.0 (web application).
Sham Comparator: Return to work coordinator only; 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.	Behavioral: Return to work coordinator only; The Return to work coordinator (RTW-C) intervenes on employees on sick leave as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sick leave duration	The number of days during the sick leave	through study completion, an average of 2 years
Relapses	Number of relapses after returning to work	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)	through study completion, an average of 2 years
Anxiety symptoms	Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)	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 )	through study completion, an average of 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social functioning	WHODAS	through study completion, an average of 2 years
Working alliance	Working Alliance Inventory (Horvath & Greenberg, 1989; Corbière et al., 2006)	through study completion, an average of 2 years
Work accommodations	Work Accommodation and Natural Support Scale (WANSS; Corbière et al., 2014)	through study completion, an average of 2 years
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

Collaborators and Investigators

• Sponsor: Université du Québec a Montréal
• Collaborators: Centre hospitalier de l'Université de Montréal (CHUM); Centre intégré de santé et de services sociaux (CISSS) de Laval; Centre intégré de santé et de services sociaux (CISSS) de la Gaspésie; Centre intégré universitaire de santé et de services sociaux du Centre Ouest de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Return to work; Clinical symptoms; Relapses; Sick leave duration
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: MSSS-23-RH-00599

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No