PTSDPEATNCT07193914
Adaptation of the ECCCLORE Program for Patients With Addictive and Traumatic Problems
A study testing ECCCLORE program in people with PTSD and Addiction, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Addiction, Substance Use Disorders
- What is being tested?
- ECCCLORE program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes, Nîmes, 30029
Anissa Megzari, MD, PhD, 06.80.13.54.39, drc@chu-nimes.fr
Laure THEBAULT
About this study
Official title: Adaptation of the ECCCLORE Program for Patients With Addictive and Traumatic Problems: Feasibility and Acceptability
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.
- Conditions
- PTSD, Addiction, Substance Use Disorders, CBT
- Being tested
- ECCCLORE program
- Medical subject headings
- Stress Disorders, Post-Traumatic, Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECCCLORE programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with addiction and trauma issues | Experimental | Not described Receives: Other: ECCCLORE program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues
Percentage of participants who attended 8 or more sessions
Measured: Week 12
Dropout rate of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues.
Percentage of participants missing 5 or more sessions
Measured: Week 12
Acceptability of the home practice section of the ECCCLORE program
Percentage of participants completing the exercises 8 or more times out of 12 sessions
Measured: Week 12
Secondary outcomes (21)
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.
Measured: Baseline
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.
Measured: Week 12
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.
Measured: Week 24
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.
Measured: Baseline
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.
Measured: Week 12
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.
Measured: Week 24
Patient-reported impulsivity
UPPS-P questionnaire used to measure positive urgency, negative urgency, lack of premeditation, lack of perseverance and sensation seeking
Measured: Baseline
Patient-reported impulsivity
UPPS-P questionnaire used to measure positive urgency, negative urgency, lack of premeditation, lack of perseverance and sensation seeking
Measured: Week 12
Patient-reported impulsivity
UPPS-P questionnaire used to measure positive urgency, negative urgency, lack of premeditation, lack of perseverance and sensation seeking
Measured: Week 24
Hostile Attribution Bias
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.
Measured: Baseline
Hostile Attribution Bias
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.
Measured: Week 12
Hostile Attribution Bias
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.
Measured: Week 24
Patient-reported aggressivity
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".
Measured: Baseline
Patient-reported aggressivity
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".
Measured: Week 12
Patient-reported aggressivity
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".
Measured: Week 24
Patient-reported flexibility
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.
Measured: Baseline
Patient-reported flexibility
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.
Measured: Week 12
Patient-reported flexibility
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.
Measured: Week 24
Patient-reported depression
Beck Depression Inventory (BDI-21)
Measured: Baseline
Patient-reported depression
Beck Depression Inventory (BDI-21)
Measured: Week 12
Patient-reported depression
Beck Depression Inventory (BDI-21)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start31 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Thebault, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193914
- Sponsor's protocol ID
- NIMAO/2024-2/LTB01
- Acronym
- PEAT
- Status last verified
- Jan 2026
- First submitted
- 18 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the ECCCLORE Program for Patients With Addictive and Traumatic Problems: Feasibility and Acceptability
- ClinicalTrials.gov ID
- NCT07193914
- Acronym / sponsor ID
- PEAT / NIMAO/2024-2/LTB01
- Conditions
- PTSD, Addiction, Substance Use Disorders, CBT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with addiction and trauma issues | Experimental | Other: ECCCLORE program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECCCLORE program2-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. | Other | Patients with addiction and trauma issues |
Primary outcome
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
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
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
21 secondary outcomes
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
Patient-reported aggressivity
Time frame: Baseline
Patient-reported aggressivity
Time frame: Week 12
Patient-reported aggressivity
Time frame: Week 24
Patient-reported flexibility
Time frame: Baseline
Patient-reported flexibility
Time frame: Week 12
Patient-reported flexibility
Time frame: Week 24
Patient-reported depression
Time frame: Baseline
Patient-reported depression
Time frame: Week 12
Patient-reported depression
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laure Thebault principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECCCLORE program in people with PTSD and Addiction, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure Thebault (06.80.13.54.39, laure.thebault@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.