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

Official title

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

Overview

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.

Interventions

• Other ECCCLORE program
  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 i

Primary outcome measures

• Feasibility of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues [Time frame: Week 12]
• Dropout rate of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues. [Time frame: Week 12]
• Acceptability of the home practice section of the ECCCLORE program [Time frame: Week 12]

Secondary outcome measures (12)

• Patient-reported trauma [Time frame: Baseline]
• Patient-reported trauma [Time frame: Week 12]
• Patient-reported trauma [Time frame: Week 24]
• Patient-reported addiction [Time frame: Baseline]
• Patient-reported addiction [Time frame: Week 12]
• Patient-reported addiction [Time frame: Week 24]
• Patient-reported impulsivity [Time frame: Baseline]
• Patient-reported impulsivity [Time frame: Week 12]
• Patient-reported impulsivity [Time frame: Week 24]
• Hostile Attribution Bias [Time frame: Baseline]
• Hostile Attribution Bias [Time frame: Week 12]
• Hostile Attribution Bias [Time frame: Week 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• CHU de Nîmes — Nîmes

Identifiers

NCT: NCT07193914 · NIMAO/2024-2/LTB01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗