Adaptation of the ECCCLORE Program for Patients With Addictive and Traumatic Problems: Feasibility and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients with addiction and trauma issues
干预措施: ECCCLORE program (Other)
结局指标
主要结局
Feasibility of a shortened 12-week ECCCLORE program for patients with addiction and trauma issues
时间窗: 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.
时间窗: Week 12
Percentage of participants missing 5 or more sessions
Acceptability of the home practice section of the ECCCLORE program
时间窗: Week 12
Percentage of participants completing the exercises 8 or more times out of 12 sessions
次要结局
- Patient-reported depression(Week 24)
- Patient-reported trauma(Baseline)
- Patient-reported trauma(Week 12)
- Patient-reported addiction(Baseline)
- Patient-reported addiction(Week 12)
- Patient-reported impulsivity(Baseline)
- Patient-reported impulsivity(Week 12)
- Hostile Attribution Bias(Baseline)
- Hostile Attribution Bias(Week 12)
- Patient-reported aggressivity(Baseline)
- Patient-reported aggressivity(Week 12)
- Patient-reported flexibility(Baseline)
- Patient-reported flexibility(Week 12)
- Patient-reported depression(Baseline)
- Patient-reported depression(Week 12)
- Patient-reported trauma(Week 24)
- Patient-reported addiction(Week 24)
- Patient-reported impulsivity(Week 24)
- Hostile Attribution Bias(Week 24)
- Patient-reported aggressivity(Week 24)
- Patient-reported flexibility(Week 24)
