Acceptability and exploratory effects of an occupational therapy intervention to improve recovery and return to work of workers with mental health disorders in primary care

ISRCTN	ISRCTN58029217
DOI	https://doi.org/10.1186/ISRCTN58029217
Protocol serial number	192030_1
Sponsor	Université de Montréal
Funder	Canadian Institutes of Health Research

Submission date: 23/02/2026
Registration date: 25/02/2026
Last edited: 25/02/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
People with common mental disorders such as depression, anxiety, obsessive-compulsive disorder, or stress‑related conditions often face difficulties at work, which may lead to sick leave. Many people do not get timely access to the support they need, and care can be inconsistent. This study aims to find out whether an occupational therapy programme delivered in family medicine groups in Québec is acceptable to patients and healthcare providers, and whether it may help people recover and return to work in a sustainable way.

Who can participate?
Adults aged 18 years and over who are seeing a family doctor or nurse practitioner for a common mental disorder and who are either starting a new sick leave or hoping to prevent one. Participants must be able to speak, read, and understand French or English. People with severe mental disorders that prevent work participation, or those already receiving specialised mental health services, cannot take part.

What does the study involve?
Participants will be referred to an occupational therapist. The programme includes three types of support: advice to help prevent sick leave or guide return‑to‑work decisions; coordination of services to support recovery and return to work; and personalised recovery and work‑related rehabilitation activities. Participants may be asked to complete questionnaires, take part in interviews, or join focus groups to help the research team understand how acceptable the programme is and what effects it may have.

What are the possible benefits and risks of participating?
The study may help participants access more coordinated and timely support for their recovery and return to work. It may also improve communication between the professionals involved in their care. As with any study, there may be minor risks such as feeling uncomfortable during interviews or when discussing personal experiences, but participation is voluntary and support will be available.

Where is the study run from?
The study is being carried out in family medicine groups in Québec, Canada, with participation from the CIUSSS de l’Est‑de‑l’Île‑de‑Montréal.

When is the study starting and how long is it expected to run for?
Recruitment began on 1 May 2025 and is expected to continue until 30 December 2026. The full study is planned to finish by 30 December 2027.

Who is funding the study?
The study is funded by the Canadian Institutes of Health Research, a national government funding organisation in Canada.

Who is the main contact?
Mrs Brigitte Vachon at the Université de Montréal
brigitte.vachon@umontreal.ca

Contact information

Mrs Brigitte Vachon
Principal investigator, Public, Scientific

Ecole de readaptation, Université de Montréal
C.P. 6128, succursale Centre-ville Montréal (Québec)
Montréal
H3C 3J7
Canada

ORCID ID	0000-0003-2899-2120
Phone	+1 514-343-2094
Email	brigitte.vachon@umontreal.ca

Study information

Primary study design	Interventional
Study design	Multiple case study
Secondary study design	Non randomised study
Scientific title	Evaluation of the acceptability of a first-line occupational therapy intervention program for the recovery and return to work of individuals with a common mental disorder (P1LIERR-TMC)
Study acronym	P1LIERR-TMC
Study objectives	The overall aim of this study is to evaluate the acceptability and explore the effects of an occupational therapist-led program, integrated within family medicine groups in the Canadian province of Québec, that is designed to improve the management of common mental disorders related sick leave and promote workers’ recovery and sustainable return to work.
Ethics approval(s)	Approved 02/05/2025, Comité d'éthique du CIUSSS de l'Est de l'Île de Montréal (5415 boulevard de l'Assomption, Montreal, H1T 2M4, Canada; +1 514-252-3400 ext. 5708; cer.cemtl@ssss.gouv.qc.ca), ref: 2025-4006
Health condition(s) or problem(s) studied	Common mental disorders
Intervention	The duration of the program is adapted to the patient's needs and can range from 1 to 12 months and consists of approximately 10 visits. The occupational therapy program consists of three components based on the best current recommendations for the management of workers with CMD, namely 1) a consultation/prevention component, 2) a recovery and RTW coordination services component, and 3) a support in recovery and work rehabilitation component. Component 1 - Consultation/prevention - Assessment of the impact of CMD on the patient’s daily life and work capacities. - Identification of factors contributing to the patient’s functional disabilities. - Support clinical decision-making process of family physicians and SNPs regarding sick leave and RTW - Recommendations to the patient and the employer to adapt work tasks or modify characteristics of the work environment. Component 2 - Coordination of recovery and RTW services - Coordination of services required to promote the patient’s recovery and RTW (RTW coordinator’s role). - Assessment of the patient’s needs and resources (e.g. insurance coverage) - Referral to the right professionals. - Communication, with the patient’s consent, with other professionals, the insurer, and the employer to foster concerted actions between stakeholders. RTW. Component 3 - Support in recovery and work rehabilitation If the patient does not have access to work rehabilitation services outside of the U-FMG. Offer interventions as described in the Therapeutic RTW program, including one or multiple of these phases: - Diagnosis of work disability: Using comprehensive assessment tools to assess the person’s current situation (e.g., Work Disability Diagnosis Interview (WoDDI)). - Preparation to work phase: improvement of quality of life and work prerequisite. - RTW phase: progressive development of work capacities and work adaptations in the real work environment. - Maintenance at work phase: assist the person in transferring knowledge in the real work environment and offer RTW support.
Intervention type	Behavioural
Primary outcome measure(s)	Work status measured using work status, job type and duration of work absence at baseline, discharge, 6-month follow-up Personal recovery outcomes measured using Brief INSPIRE-O at baseline, discharge, 6-month follow-up
Key secondary outcome measure(s)	Return to work self-efficacy measured using Return to work self-efficacy questionnaire at baseline, discharge, 6-month follow-up Work functioning measured using Work role functioning quesionnaire at baseline, discharge, 6-month follow-up Intensity of anxiety symptoms measured using GAD-7 at baseline, discharge, 6-month follow-up Intensity of depressive symptoms measured using PHQ-9 at baseline, discharge, 6-month follow-up Self-perceived health-related quality of life measured using SF-12 at baseline, discharge, 6-month follow-up Level of life balance measured using Occupational Balance Questionnaire at baseline, discharge, 6-month follow-up
Completion date	30/12/2027

Eligibility

Participant type(s)	Health professional, Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	120 Years
Sex	All
Target sample size at registration	132
Key inclusion criteria	1. Consulting a family physician or a SNP for a CMD 2. Referred to the occupational therapist for a new episode of sick leave or wish to prevent a sick leave 3. Able to speak, read, and understand French or English In this study, CMDs include depressive disorders, anxiety disorders, obsessive-compulsive disorder, and trauma- or stress-related disorders, including adjustment disorders.
Key exclusion criteria	1. Have a diagnosis of a severe mental disorder limiting work integration or participation 2. Require or receive services from a specialized mental health care team
Date of first enrolment	01/05/2025
Date of final enrolment	30/12/2026

Locations

Countries of recruitment

Canada

Study participating centre

CIUSSS de l'Est de l'Ile de Montréal

5415 boulevard de l'Assomption
Montreal
H1T 2M4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and analysed during the current study will be available upon request from brigitte.vachon@umontreal.ca

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		28/11/2024	24/02/2026	Yes	No

Editorial Notes

24/02/2026: Trial's existence confirmed by Comité d'éthique du CIUSSS de l'Est de l'Île de Montréal.