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

C

Centre Hospitalier Universitaire de Nīmes

Status

Enrolling

Conditions

CBT
PTSD
Addiction
Substance Use Disorders

Treatments

Other: ECCCLORE program

Study type

Interventional

Funder types

Other

Identifiers

NCT07193914
NIMAO/2024-2/LTB01

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Patients with addiction and trauma issues
Experimental group
Treatment:
Other: ECCCLORE program

Trial contacts and locations

1

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Central trial contact

Laure Thebault

Data sourced from clinicaltrials.gov

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