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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
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.
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.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Rate of competitive employment (at least 1 day worked in the open labour market, expressed as a percentage)
Time frame: Change from baseline at 6 months after enrollement
Number of individual sessions with a vocational counsellor
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Number of telephone sessions with a vocational counsellor
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Number of group workshops attended
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Number of workplace immersions
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Number of meetings with employers
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Number of internships
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Number of skill training program followed
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Number of job applications submitted
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Number and type of jobs held
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Time to first employment
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Duration of longest employment held
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Total time worked
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Job satisfaction
Job satisfaction will be assessed using a single-item measure derived from the Job Satisfaction Scale. Responses are recorded on a 7-point Likert scale ranging from 1 to 7, with higher scores indicating greater job satisfaction.
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Return to work self efficacy
Return-to-work self-efficacy will be assessed using the 11-item Return-to-Work Self-Efficacy Scale (RTW-SE-11). Responses are recorded on a 6-point Likert scale and the total score ranges from 1 to 6, with higher scores indicating greater return-to-work self-efficacy. A score ≥4.5 is considered indicative of high self-efficacy.
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Work Ability Index
Work ability will be assessed using the Work Ability Index (WAI). Responses are recorded across 7 sections comprising a total of 10 items, using multiple numeric scales. The total score ranges from 7 to 49, with higher scores indicating better work ability.
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Work Readiness Questionnaire
Work readiness will be assessed using the Work Readiness Questionnaire (WRQ). The questionnaire consists of 7 items completed by a clinician to provide a global judgment of the individual's ability to work. No total score is calculated, as the outcome is based on an overall clinical assessment of work readiness.
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Work Related Recovery Expectations
Work-related recovery expectations will be assessed using the Work-related Recovery Expectations Questionnaire (WRREQ). The questionnaire consists of 3 items, with responses recorded on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 3 to 15, with lower scores indicating better recovery expectations.
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Coping strategies
Coping strategies will be assessed using the 24-item Brief COPE questionnaire. Responses are recorded on a 4-point Likert scale ranging from 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot"). Scores are calculated for each subscale, with higher scores indicating greater use of the corresponding coping strategy
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Global functioning
Global and social functioning will be assessed using the Global Assessment of Functioning (GAF) scale. This clinician-rated measure evaluates psychological, social, and occupational functioning. Scores range from 0 to 100, in 10-point intervals with the possibility of using intermediate ratings, with higher scores indicating better functioning
Time frame: Changes from baseline at 3 and 6 months after enrollement
Quality of Life Assessment
Quality of life will be assessed using the World Health Organization Quality of Life - Brief version (WHOQOL-BREF). The questionnaire consists of 26 items, with responses recorded on a 5-point Likert scale. Scores are calculated across four domains (physical health, psychological health, social relationships, and environment), each transformed to a scale ranging from 0 to 20, with higher scores indicating better quality of life
Time frame: Changes from baseline at 3 and 6 months after enrollement
Disease Severity
Disease severity and improvement will be assessed using the Clinical Global Impressions scales - Severity (CGI-S) and Improvement (CGI-I). These clinician-rated measures evaluate the severity of illness and change over time. Both scales are rated on a 7-point scale, with higher scores on the CGI-S indicating greater illness severity and higher scores on the CGI-I indicating less improvement compared to baseline.
Time frame: Changes from baseline at 3 and 6 months after enrollement
Stress Response - Salivary biomarkers of stress
Physiological stress response will be assessed using salivary biomarkers collected during an adapted Trier Social Stress Test (TSST). Saliva samples will be analyzed for multiple biomarkers, including cortisol, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), leptin, ghrelin, and/or alpha-amylase. Samples will be collected at three time points: prior to the active phase (20 minutes), immediately after the simulated job interview (35 minutes), and after the debriefing phase (55 minutes), with changes in biomarker levels reflecting the physiological stress response.
Time frame: Changes from baseline at 6 months after enrollement
Stress Response - Heart Rate Variability
Physiological stress response will be assessed using heart rate variability (HRV) measured continuously during an adapted Trier Social Stress Test (TSST). HRV is recorded in milliseconds using a wearable device throughout the entire task, from the initial resting phase to the recovery period, with changes in HRV reflecting autonomic nervous system responses to stress.
Time frame: Changes from baseline at 6 months after enrollement
Stress response - Percieved stress
Perceived stress will be assessed using visual analogue scales administered during an adapted Trier Social Stress Test (TSST). Participants rate their perceived stress and related states (e.g., fatigue, sleep) at multiple time points using brief visual analogue scales, with higher scores indicating greater perceived stress.
Time frame: Changes from baseline at 6 months after enrollement
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