Trials / Not Yet Recruiting

Not Yet RecruitingNCT07520617

Evaluation of the ADD'Pro Vocational Reintegration Program (ADD-PRO-EVAL)

Evaluation of the ADD'Pro Program: A Partnership-Based Approach to Support Vocational Reintegration of Patients Receiving Addiction Care (ADD-PRO-EVAL)

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 100 (estimated)

Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
Sex: All
Age: 16 Years – 70 Years
Healthy volunteers: Not accepted

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

Detailed description

Returning to work is a key component of recovery for people with substance use disorders (SUD). Employment not only reduces the risk of relapse and decreases substance use, but also contributes broadly to improved mental health, financial stability, and social integration. Yet despite a strong and often expressed desire to return to professional life, employment rates among patients receiving addiction care remain critically low. This paradox between motivation and actual vocational outcomes reflects the multiple barriers these patients face: stigma from employers, gaps in employment history, cognitive difficulties, comorbid psychiatric conditions, and a lack of coordinated support bridging the medical and professional domains. Standard employment services are valuable yet are rarely designed to address the specific complexity of addiction-related needs. They operate independently from healthcare teams, with limited awareness of the medical and psychosocial factors that affect a patient's readiness and capacity to work. This disconnect frequently results in patients being referred too early, without adequate preparation, or simply falling through the gap between health and employment systems. To address this unmet need, the ADD'Pro program was developed as a structured partnership between the Day Hospital for Addiction (Hôpital de Jour d'Addictologie, HDJA) at Clermont-Ferrand University Hospital and the CeCler Association, a non-profit organization specializing in both social and vocational insertion. The program offers a medico-psychosocial support pathway that integrates clinical addiction care with individualised vocational guidance. From the outset, patients receive support on both fronts simultaneously: multidisciplinary assessment and treatment within the HDJA, combined with personalized accompaniment by a vocational counsellor (conseiller en insertion professionnelle, CIP) from the CeCler Association. The ADD'Pro pathway unfolds in four key phases: (1) raising awareness about employment through a structured group workshop held at the HDJA; (2) a comprehensive vocational assessment exploring the patient's professional history, aspirations, barriers, and readiness to work; (3) active, individualised dual support combining medical care and vocational guidance, including job search preparation, employer outreach, workplace immersions, and skills development; and (4) open-ended follow-up by the CeCler Association beyond the hospital care period, including post-placement support to promote job retention. Coordination between the two structures is ensured by a psychologist-doctoral researcher who facilitates regular joint meetings and continuity of care. The ADD-PRO-EVAL study is a prospective, open-label, single-center randomized controlled trial designed to evaluate the effectiveness of this program compared to standard care. One hundred participants with SUD currently receiving care at the HDJA will be enrolled over a two-year recruitment period and randomly assigned (1:1 ratio) to one of two arms. Participants in the ADD'Pro-Initial arm will immediately receive the full ADD'Pro program alongside their standard hospital care. Participants in the Standard Care arm will be referred to conventional employment services (France Travail or Cap Emploi), with monthly follow-up interviews conducted at the HDJA to monitor their employment-seeking activities; they will have the option to access ADD'Pro after six months. The primary outcome is the rate of competitive employment, defined as at least one day worked in the open labour market - at six months post-inclusion. Secondary outcomes are extensive and cover multiple dimensions of vocational and health-related recovery. These include: participation in employment preparation activities (individual and group sessions with counsellors, workplace immersions, job applications, internships, and vocational training); detailed employment outcomes such as time to first job, total time worked, and job retention; work-related psychological factors including return-to-work self-efficacy (RTW-SE-11), work ability (Work Ability Index), and work-related recovery expectations (WRREQ); broader health indicators including coping strategies (Brief-COPE), global functioning (GAF scale), quality of life (WHOQOL-Bref), and addiction severity (CGI-S/CGI-I). In addition, a sub-sample of up to 50 participants will undergo an adapted version of the Trier Social Stress Test (TSST) - a simulated job interview protocol - with collection of salivary biomarkers (cortisol, DHEA, leptin, ghrelin, alpha-amylase…) and continuous heart rate variability monitoring, to explore physiological stress reactivity as a marker of vocational readiness. All participants will be assessed at inclusion (T0), 3 months, 6 months (primary endpoint), and 12 months. Randomization is computer-generated with variable block sizes, stratified by age. Statistical analyses will follow the intention-to-treat principle. The ADD'Pro-EVAL trial aims to generate robust evidence on the value of integrated medico-psychosocial support for vocational reintegration in addiction care with potential implications for clinical practice, healthcare policy, and the design of future collaborative programs between health and employment services.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	ADD'Pro Program	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.
BEHAVIORAL	Standard Care (in control arm)	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.

Timeline

Start date: 2026-04-01
Primary completion: 2029-04-01
Completion: 2029-04-01
First posted: 2026-04-09
Last updated: 2026-04-09

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07520617. Inclusion in this directory is not an endorsement.