A Randomized Controlled Trial Comparing (1) a Combined Treatment of CBT for Substance Use Disorders (SUD) and Trauma-focused Structured Writing Therapy With (2) CBT for SUD Alone in Patients With Comorbid SUD and PTSD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Substance use assessed with the Time-Line Follow-Back Interview (TLFB; Sobell & Sobell, 1996)
研究概览
简要总结
This study is a randomized controlled trial comparing two treatments for patients with comorbid substance use disorder (SUD) and post-traumatic stress disorder (PTSD) conducted within two different routine clinical settings for the treatment of SUD, namely (a) a day-care and inpatient setting and (b) an outpatient setting. Participants will be randomly assigned to either (1) a combination of cognitive-behavioral treatment (CBT) for SUD and trauma-focused structured writing therapy, or (2) CBT for SUD alone. Randomization will take place separately for each setting. It is expected that the combined treatment is significantly more effective in reducing symptoms of SUD as well as PTSD than CBT for SUD alone. Outcome measures will be assessed at pre-treatment, post-treatment as well as 3 months, 6 months and 12 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of substance abuse or substance dependence according to DSM-IV
- •Diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (at least one re-experiencing symptom plus either three avoidance/numbing or two hyperarousal symptoms are present)
- •18 years or older
- •Sufficient fluency in Dutch or English to complete treatment and research procedures
排除标准
- •Severe psychiatric problems that may interfere with study participation or that require more intensive clinical care than can be offered in the present study (e.g., dementia, psychotic symptoms, depression with suicidal ideation, manic episode and borderline personality disorder)
- •Receiving concurrent psychotherapy
- •Participants using tranquilizers are required to terminate medication use before inclusion
- •Participants using anti-depressant medication are required to stabilize medication use before inclusion.
结局指标
主要结局
Substance use assessed with the Time-Line Follow-Back Interview (TLFB; Sobell & Sobell, 1996)
时间窗: Pre-treatment, Post-treatment; 3 months follow-up; 6 months; 12 months follow-up
PTSD symptom severity assessed with the Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)
时间窗: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
DSM-IV diagnoses of SUD and PTSD assessed with the Structured Clinical Interview for the DSM-IV (SCID)
时间窗: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
次要结局
- Inventory of Drug Use Consequences (INDUC-2r)(Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up)
- Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ)(Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up)
- Metacognitions concerning alcohol and/or drug-use assessed with the Positive Alcohol Metacognitions Scale (PAMS)(Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up)
- Difficulties in Emotion regulation (DERS)(Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up)
- Interpretation of PTSD-symptoms (PTSD-IPSI)(Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up)
- Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)(Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up)
研究者
Paul M.G.Emmelkamp
Proffesor
VU University of Amsterdam