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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

Trial Parameters

Condition PTSD
Sponsor Centre Hospitalier Universitaire de Nīmes
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-31
Completion 2027-03
Interventions
ECCCLORE program

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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 pri

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