ECCCLORE group program for people with addiction and trauma-related PTSD

Adaptation of the ECCCLORE Program for Patients With Addictive and Traumatic Problems: Feasibility and Acceptability

This program will try a group-based ECCCLORE therapy to see if it helps people who have addiction and PTSD or complex PTSD reduce substance use and impulsive or hostile behaviors.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (other)
• Locations: 1 site (Nîmes, Nîmes)
• Trial ID: NCT07193914 on ClinicalTrials.gov

What this trial studies

This interventional program adapts the ECCCLORE group therapy to treat adults with one or more substance addictions who also meet criteria for PTSD or complex PTSD on the ITQ. The intervention targets transdiagnostic processes such as impulsivity and hostile attribution bias that link trauma and addictive behaviors, delivered in a group format at CHU de Nîmes and requiring French language ability. Participants are screened with the ASSIST for substance use severity and excluded for psychotic disorders, severe cognitive impairment (MoCA < 10), current manic/hypomanic episodes, or major depressive episodes. The protocol is non-pharmacologic and focuses on psychotherapeutic techniques tailored to the trauma-addiction comorbidity.

Who should consider this trial

Good fit: Adults with one or more addictions who score at or above the ASSIST thresholds (≥11 for alcohol, ≥4 for other substances), have PTSD or cPTSD on the ITQ, can read and write French, provide informed consent, and are covered by a health insurance plan.

Not a fit: Patients with psychotic disorders, severe cognitive impairment (MoCA < 10), current manic or major depressive episodes, those unable to read/write French, or those unable to attend in-person group sessions are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could help participants reduce substance use, improve emotion regulation, lower aggression and impulsivity, and improve overall quality of life.

How similar studies have performed: Integrated psychological treatments for trauma and addiction have shown some promise, but group-format interventions specifically targeting this comorbidity remain relatively novel and lack strong empirical support.

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

Where this trial is running

Nîmes, Nîmes

• CHU de Nîmes — Nîmes, Nîmes, France (RECRUITING)

Study contacts

• Principal investigator: Laure Thebault — CHU de Nimes
• Study coordinator: Laure Thebault

Conditions: PTSD, Addiction, Substance Use Disorders, CBT