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Recruiting NCT07193914

NCT07193914 Adaptation of the ECCCLORE Program for Patients With Addictive and Traumatic Problems

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Clinical Trial Summary
NCT ID NCT07193914
Status Recruiting
Phase
Sponsor Centre Hospitalier Universitaire de Nīmes
Condition PTSD
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2025-10-31
Primary Completion 2027-03

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
ECCCLORE program

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2025-10-31 with a primary completion date of 2027-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Complex posttraumatic stress disorder (cPTSD) is characterized by chronic and pervasive disruptions in emotion regulation, identity, and relationships following prolonged or multiple exposures to trauma. It is frequently found in patients with addiction. Individuals with cPTSD have more severe addiction. In addition, the co-occurrence of these two disorders is often associated with certain transdiagnostic processes such as impulsivity. Indeed, PTSD is linked to a higher impulsivity score, which in turn promotes increased substance use. A second process also associated with trauma and addiction is hostile attribution bias. Thus, the trauma-addiction comorbidity generates multiple behavioral consequences (aggression, increased substance use, etc.) that impact patients' quality of life and represent an important treatment target. Many authors and clinicians have worked on creating treatment programs targeting both disorders, although group format treatment lacks empirical support. Indeed, even though the Seeking Safety program has been shown to be effective in reducing PTSD symptoms and substance use, there is currently no evidence to suggest its superiority. The ECCCLORE program is a new 6-month cognitive behavioral therapy protocol initially designed for patients with borderline personality disorder, in whom addictive and traumatic issues are common. It is shorter than the standard dialectical behavioral therapy (DBT) program, which focuses on emotional dysregulation, impulsivity, and the traumatic dimension and lasts at least 1 year. It also integrates techniques from other approaches such as Acceptance and Commitment Therapy (ACT), which promotes the acceptance of internal experiences and engagement in actions consistent with values. It notably contains tools for developing emotional, distress tolerance, and interpersonal skills that could adapt to the difficulties generated by trauma and addiction. The objective of this research is to test the feasibility and acceptability of a 12-week ECCCLORE program adapted for patients with addictive and traumatic problems. The study investigators hypothesize that the implementation of this program will demonstrate satisfactory feasibility and acceptability.

Eligibility Criteria

Inclusion Criteria: * Patients with one or more addictions * ASSIST questionnaire score greater than or equal to 11 for alcohol consumption and greater than or equal to 4 for other substances. * Diagnosis of PTSD and/or CPTSD assessed using the ITQ scale. * Ability to understand, write, and read French * The patient must have given their free and informed consent * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * The subject is participating in an interventional study involving a drug or medical device or a Category 1 study within 3 months prior to inclusion * The patient is under safeguard of justice or state guardianship * Patients with a psychotic disorder * Patients with severe cognitive impairment (MoCA \< 10) * Patients experiencing a manic or hypomanic episode * Patients experiencing a major depressive episode * Patients participating in an interventional study involving a drug or medical device or a Category 1 RIPH within 3 months prior to inclusion * Pregnant, parturient, or breastfeeding woman

Contact & Investigator

Central Contact

Laure Thebault

✉ laure.thebault@chu-nimes.fr

📞 06.80.13.54.39

Principal Investigator

Laure Thebault

PRINCIPAL INVESTIGATOR

CHU de Nimes

Frequently Asked Questions

Who can join the NCT07193914 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07193914 currently recruiting?

Yes, NCT07193914 is actively recruiting participants. Contact the research team at laure.thebault@chu-nimes.fr for enrollment information.

Where is the NCT07193914 trial being conducted?

This trial is being conducted at Nîmes, France.

Who is sponsoring the NCT07193914 clinical trial?

NCT07193914 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Laure Thebault at CHU de Nimes. The trial plans to enroll 30 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology