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

NCT07193914 | Recruiting

• 1 other identifier: NIMAO/2024-2/LTB01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; CBT; PTSD; Addiction

Outcome Measures

Primary Outcomes (3)

• Feasibility of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues

  Percentage of participants who attended 8 or more sessions

  Week 12

• Dropout rate of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues.

  Percentage of participants missing 5 or more sessions

  Week 12

• Acceptability of the home practice section of the ECCCLORE program

  Percentage of participants completing the exercises 8 or more times out of 12 sessions

  Week 12

Secondary Outcomes (21)

• Patient-reported trauma

  Baseline

• Patient-reported trauma

  Week 12

• Patient-reported trauma

  Week 24

• Patient-reported addiction

  Baseline

• Patient-reported addiction

  Week 12

Study Arms (1)

Patients with addiction and trauma issues

EXPERIMENTAL

Other: ECCCLORE program

Interventions

ECCCLORE program OTHER

2-hour sessions in groups of up to 10 people, once a week for 12 weeks plus 30-minute individual sessions after each group session At the beginning of each session, there will be a discussion about the past week and home practices. This will be followed by an alternation between presentations/explanations of key concepts and associated practices. In the individual sessions the previous session and any difficulties encountered during the group session will be reviewed, as well as to address the implementation of home practices.

Patients with addiction and trauma issues

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant, parturient, or breastfeeding woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Behavior, Addictive; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Chemically-Induced Disorders

Study Officials

• Laure Thebault

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure Thebault

CONTACT

06.80.13.54.39; laure.thebault@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 26, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

FR (1)