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Completed

NCT Number: NCT06397326

Sustainable and Healthy Return-to-Work Program - 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université du Québec à Montréal (UQAM), Department of Education and Pedagogy, Career Counselling

Montreal, Quebec, H3C 3P8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Return to work coordinator + PRATICAdr 2.0

Behavioral

The Return to work coordinator (RTW-C) uses PRATICAdr. 2.0 (web application).

Return to work coordinator only

Behavioral

The Return to work coordinator (RTW-C) intervenes on employees on sick leave as usual

Primary outcomes

  1. Sick leave duration

    Time frame: through study completion, an average of 2 years

    The number of days during the sick leave

  2. Relapses

    Time frame: through study completion, an average of 2 years

    Number of relapses after returning to work

Secondary outcomes

  1. Depressive symptoms

    Time frame: through study completion, an average of 2 years

    Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)

  2. Anxiety symptoms

    Time frame: through study completion, an average of 2 years

    Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)

  3. Return to Work Obstacles and Self-Efficacy

    Time frame: through study completion, an average of 2 years

    Return to Work Obstacles and Self-Efficacy Scale (ROSES ; Corbière et al., 2017 )

Other outcomes

  1. Social functioning

    Time frame: through study completion, an average of 2 years

    WHODAS

  2. Working alliance

    Time frame: through study completion, an average of 2 years

    Working Alliance Inventory (Horvath & Greenberg, 1989; Corbière et al., 2006)

  3. Work accommodations

    Time frame: through study completion, an average of 2 years

    Work Accommodation and Natural Support Scale (WANSS; Corbière et al., 2014)

  4. Work recognition

    Time frame: through study completion, an average of 2 years

    Recognition by stakeholders of returning to work following a common mental disorder (RECONNECT, Corbière, Larivière, Charette-Dussault, 2021)

Sponsors and collaborators

Lead sponsor

Université du Québec a Montréal

Other

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

Registry information

Official study title

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

Acronym: PRATICAdr

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 2, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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