Addiction, CBT, PTSD, Substance Use Disorders
Conditions
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.
Interventions
OTHERECCCLORE 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 implementation of home practices.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues | Week 12 | Percentage of participants who attended 8 or more sessions |
| Dropout rate of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues. | Week 12 | Percentage of participants missing 5 or more sessions |
| Acceptability of the home practice section of the ECCCLORE program | Week 12 | Percentage of participants completing the exercises 8 or more times out of 12 sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported trauma | 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. |
| Patient-reported addiction | 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. |
| Patient-reported impulsivity | Baseline | UPPS-P questionnaire used to measure positive urgency, negative urgency, lack of premeditation, lack of perseverance and sensation seeking |
| Hostile Attribution Bias | 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. |
| Patient-reported aggressivity | 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". |
| Patient-reported flexibility | 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. |
| Patient-reported depression | Baseline | Beck Depression Inventory (BDI-21) |
Countries
France
Contacts
CONTACTLaure Thebault
PRINCIPAL_INVESTIGATORLaure Thebault
CHU de Nimes
Outcome results
None listed