An interventional study of ADD'Pro Program and Standard Care (in control arm) in Addiction, Addiction Disorders and Substance Use Recovery, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other
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:
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 100 is close to the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
Compared within Substance-Related Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Behavior, Addictive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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.
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
Job placement adequacy
ob placement adequacy will be assessed through a structured qualitative evaluation of the alignment between individual job preferences, competencies, and employment outcomes. This evaluation will be conducted by the investigator, a member of the research team, and/or a vocational integration counsellor using predefined criteria, including job type, skill match, and consistency with the participant's initial vocational goals. Assessments will be performed at 3, 6, and 12 months.
Time frame: Changes from baseline at 3, 6 and 12 months after enrollement
Start is estimated for Apr 2026; primary completion for Apr 2029, 36 months later.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 36 months is close to that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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