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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • ECCCLORE program

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients with addiction and trauma issuesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Percentage of participants who attended 8 or more sessions

Time frame
Week 12
2

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

Percentage of participants missing 5 or more sessions

Time frame
Week 12
3

Acceptability of the home practice section of the ECCCLORE program

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

Time frame
Week 12

Secondary outcomes

1

Patient-reported trauma

International Trauma Questionnaire (ITQ), where PTSD requires the presence of at least one symptom in each of the three symptom clusters plus at least one indicator of functional impairment corresponding to a score ≥ 2 on one item. CPTSD further requires confirmation of at least one symptom in each cluster of disturbance in self-organization and associated functional impairment.

Time frame
Baseline
2

Patient-reported trauma

International Trauma Questionnaire (ITQ), where PTSD requires the presence of at least one symptom in each of the three symptom clusters plus at least one indicator of functional impairment corresponding to a score ≥ 2 on one item. CPTSD further requires confirmation of at least one symptom in each cluster of disturbance in self-organization and associated functional impairment.

Time frame
Week 12
3

Patient-reported trauma

International Trauma Questionnaire (ITQ), where PTSD requires the presence of at least one symptom in each of the three symptom clusters plus at least one indicator of functional impairment corresponding to a score ≥ 2 on one item. CPTSD further requires confirmation of at least one symptom in each cluster of disturbance in self-organization and associated functional impairment.

Time frame
Week 24
4

Patient-reported addiction

Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), for alcohol a score 0-10 is classed as low risk, 11-26: moderate risk, 27 or more: high risk and for other substances: 0-3: low risk, 4-26: moderate risk, 27 or more: high risk.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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