NCT07520617

Brief Summary

The goal of this clinical trial is to evaluate whether an integrated medico-psychosocial vocational support program (ADD'Pro) can improve employment outcomes in adults with substance use disorders receiving care at a specialized addiction day hospital. The main question it aims to answer is: \- Does participation in the ADD'Pro program increase the rate of competitive employment (at least one day worked in the open labour market) at 6 months compared to standard employment services? Researchers will compare participants enrolled in the ADD'Pro program to participants referred to conventional employment services (France Travail or Cap Emploi) to see if structured, dual medico-psychosocial support leads to higher rates of vocational reintegration, better employment preparation, improved quality of life, and reduced physiological stress reactivity. Participants will:

  • Be randomly assigned to either the ADD'Pro program or standard employment services
  • If assigned to ADD'Pro: receive immediate individualised support from a vocational counsellor (CIP) at the CeCler Association, running in parallel with their hospital addiction care, with no fixed end date
  • If assigned to standard care: be referred to conventional employment services with monthly follow-up interviews at the hospital, and the option to join ADD'Pro after 6 months
  • Complete structured interviews and validated questionnaires at inclusion, 3, 6, and 12 months
  • A sub-sample of up to 50 participants will additionally take part in a simulated job interview stress test (adapted TSST) with salivary biomarker collection and heart rate monitoring at inclusion and 6 months

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

April 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 27, 2026

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of competitive employment (at least 1 day worked in the open labour market, expressed as a percentage)

    Change from baseline at 6 months after enrollement

Secondary Outcomes (24)

  • Number of individual sessions with a vocational counsellor

    Changes from baseline at 3, 6 and 12 months after enrollement

  • Number of telephone sessions with a vocational counsellor

    Changes from baseline at 3, 6 and 12 months after enrollement

  • Number of group workshops attended

    Changes from baseline at 3, 6 and 12 months after enrollement

  • Number of workplace immersions

    Changes from baseline at 3, 6 and 12 months after enrollement

  • Number of meetings with employers

    Changes from baseline at 3, 6 and 12 months after enrollement

  • +19 more secondary outcomes

Other Outcomes (1)

  • Job placement adequacy

    Changes from baseline at 3, 6 and 12 months after enrollement

Study Arms (2)

ADD'Pro-Initial

EXPERIMENTAL

Immediate access to the ADD'Pro program from the first care sequence at the HDJA. Participants receive dual support: hospital-based addiction care (HDJA) combined with vocational guidance from a professional insertion counsellor (CIP) at the CeCler Association. The program is inspired by the IPS (Individual Placement and Support) model and continues indefinitely, with no fixed end date.

Behavioral: ADD'Pro Program

Standard Care

ACTIVE COMPARATOR

Participants are referred to standard employment services (France Travail or Cap Emploi). Registration is facilitated at the HDJA if needed. Monthly follow-up interviews are conducted to track employment-seeking activities. Participants may access the ADD'Pro program after 6 months.

Behavioral: Standard Care (in control arm)

Interventions

ADD'Pro ProgramBEHAVIORAL

ADD'Pro is a structured medico-psychosocial vocational support program delivered in four phases: (1) a group awareness workshop on employment held at the addiction day hospital (HDJA); (2) a comprehensive individualised vocational assessment covering professional history, aspirations, barriers, and work readiness; (3) active dual support combining ongoing addiction care at the HDJA with personalized accompaniment by a vocational counsellor (CIP) from the CeCler Association, including job search preparation, employer outreach, workplace immersions, and skills development; (4) open-ended post-placement follow-up by the CeCler Association with no fixed end date, continuing beyond the hospital care period. Coordination between the clinical and vocational teams is ensured by a dedicated psychologist-doctoral researcher through regular joint meetings. The program runs in parallel with standard addiction care and is initiated from the patient's first care sequence at the HDJA.

ADD'Pro-Initial

Participants assigned to the standard care arm are referred to conventional employment services available under French law: France Travail (formerly Pôle Emploi) for general job seekers, or Cap Emploi for individuals with disabilities. Registration with the relevant service is facilitated at the HDJA if not already completed. Participants receive the employment support services routinely provided by these organizations, without any additional vocational guidance from the ADD'Pro program or the CeCler Association. In parallel, monthly follow-up interviews are conducted at the HDJA by a member of the research team to monitor employment-seeking activities and collect study outcome data. Standard addiction care at the HDJA continues unchanged throughout the study period. Participants in this arm have the option to access the ADD'Pro program after the 6-month primary endpoint assessment.

Standard Care

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult of working age (18 years or older)
  • Diagnosed substance use disorder receiving medical care
  • Unemployed or on sick leave with a vocational reorientation project
  • Motivated to work in the competitive labour market
  • Living in or wishing to work in the Puy-de-Dôme department (63), France
  • Legally authorised to work
  • Capable of providing written informed consent
  • Affiliated with a French social security scheme

You may not qualify if:

  • Medical care provided under a court-ordered treatment obligation
  • Previously included in the ADD'Pro program
  • Residing outside the Puy-de-Dôme with no plan to work in the department
  • Under legal guardianship (tutelle, curatelle, or sauvegarde de justice)
  • Deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Behavior, AddictiveSubstance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Georges Brousse

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 9, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

April 9, 2026

Record last verified: 2026-03

Locations