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NCT Number: NCT07193914

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

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.

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Key information

Conditions

PTSD Addiction Behavior Behavior, Addictive CBT Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance Use Disorders Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, 30029, France

Location status: Recruiting

Location contact

Anissa Megzari, MD, PhD

CONTACT

[email protected]

06.80.13.54.39

Laure THEBAULT

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Week 12

    Percentage of participants who attended 8 or more sessions

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

    Time frame: Week 12

    Percentage of participants missing 5 or more sessions

  3. Acceptability of the home practice section of the ECCCLORE program

    Time frame: Week 12

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

Secondary outcomes

  1. Patient-reported trauma

    Time frame: Baseline

    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.

  2. Patient-reported trauma

    Time frame: Week 12

    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.

  3. Patient-reported trauma

    Time frame: Week 24

    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.

  4. Patient-reported addiction

    Time frame: Baseline

    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.

  5. Patient-reported addiction

    Time frame: Week 12

    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.

  6. Patient-reported addiction

    Time frame: Week 24

    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.

  7. Patient-reported impulsivity

    Time frame: Baseline

    UPPS-P questionnaire used to measure positive urgency, negative urgency, lack of premeditation, lack of perseverance and sensation seeking

  8. Patient-reported impulsivity

    Time frame: Week 12

    UPPS-P questionnaire used to measure positive urgency, negative urgency, lack of premeditation, lack of perseverance and sensation seeking

  9. Patient-reported impulsivity

    Time frame: Week 24

    UPPS-P questionnaire used to measure positive urgency, negative urgency, lack of premeditation, lack of perseverance and sensation seeking

  10. Hostile Attribution Bias

    Time frame: Baseline

    Word Sentence Association Paradigm-Hostility (WSAP-H), in which hostile attribution biases are calculated by averaging the scores across the 16 trials with a hostile word. The higher the score, the greater the hostile attribution bias.

  11. Hostile Attribution Bias

    Time frame: Week 12

    Word Sentence Association Paradigm-Hostility (WSAP-H), in which hostile attribution biases are calculated by averaging the scores across the 16 trials with a hostile word. The higher the score, the greater the hostile attribution bias.

  12. Hostile Attribution Bias

    Time frame: Week 24

    Word Sentence Association Paradigm-Hostility (WSAP-H), in which hostile attribution biases are calculated by averaging the scores across the 16 trials with a hostile word. The higher the score, the greater the hostile attribution bias.

  13. Patient-reported aggressivity

    Time frame: Baseline

    Aggression Questionnaire (AQ-12). Items are rated using a 6-point Likert-type scale ranging from 1 "does not apply to me at all" to 6 "applies to me completely".

  14. Patient-reported aggressivity

    Time frame: Week 12

    Aggression Questionnaire (AQ-12). Items are rated using a 6-point Likert-type scale ranging from 1 "does not apply to me at all" to 6 "applies to me completely".

  15. Patient-reported aggressivity

    Time frame: Week 24

    Aggression Questionnaire (AQ-12). Items are rated using a 6-point Likert-type scale ranging from 1 "does not apply to me at all" to 6 "applies to me completely".

  16. Patient-reported flexibility

    Time frame: Baseline

    Multidimensional Psychological Flexibility Inventory Short-Form (MPFI-24), only items 1 to 12 will be tested: acceptance, awareness of the present moment, defusion, self as context, contact with values, and committed actions.

  17. Patient-reported flexibility

    Time frame: Week 12

    Multidimensional Psychological Flexibility Inventory Short-Form (MPFI-24), only items 1 to 12 will be tested: acceptance, awareness of the present moment, defusion, self as context, contact with values, and committed actions.

  18. Patient-reported flexibility

    Time frame: Week 24

    Multidimensional Psychological Flexibility Inventory Short-Form (MPFI-24), only items 1 to 12 will be tested: acceptance, awareness of the present moment, defusion, self as context, contact with values, and committed actions.

  19. Patient-reported depression

    Time frame: Baseline

    Beck Depression Inventory (BDI-21)

  20. Patient-reported depression

    Time frame: Week 12

    Beck Depression Inventory (BDI-21)

  21. Patient-reported depression

    Time frame: Week 24

    Beck Depression Inventory (BDI-21)

Study contacts

Contact information is provided by the study sponsor or research team.

Laure Thebault

CONTACT

[email protected]

06.80.13.54.39

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: PEAT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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