Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores
研究概览
简要总结
Participants are randomly assigned to either 16 sessions of Brief Eclectic Psychotherapy (Gersons et al. (2000) Journal Trauma Stress 13: 333-348), comprising psychoeducation, exposure, mementos and writing assignments, domain of meaning and integration, farewell ritual, or a minimal attention control group that will be offered 16 sessions of BEP after a waiting time of four months. Participants in the minimal attention control group receive monthly telephone calls and complete a symptom self monitoring diary (Tarrier, N. et al. (1999) Behavior Therapy 30: 597-605) for three weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clear memory of an "index" traumatic event (sufficient for constructing a scene to be used in exposure) that occurred no less than six months prior to entering the trial (Montgomery and Bech 2000)
- •PTSD according to the DSM-IV, related to the index traumatic event, as measured with the CAPS: frequency ≥ 1 and intensity ≥ 2 for a symptom to be counted plus a minimum level of overall severity ≥ 50
- •Not receiving other psychotherapy for PTSD during the 16 weeks of active treatment; psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed
- •If on psychoactive medication: on a stable medication regimen for a minimum of two months prior to entering the trial
- •Aged between 18 and 70 years
- •Sufficient proficiency in the German language to participate in BEP
- •Consent to be randomized into the trial
排除标准
- •Current psychotic, bipolar, substance-related, or severe personality disorder
- •Current severe depressive disorder
- •Severe cognitive impairment or a history of organic mental disorder
- •Evidence of PTSD or depression immediately prior to the index trauma
- •Ongoing threat of traumatic exposure
- •Prominent current suicidal or homicidal ideation
- •Asylum seeking status
研究组 & 干预措施
Treatment group
16 sessions Brief Eclectic Psychotherapy
干预措施: Brief Eclectic Psychotherapy for PTSD (Behavioral)
Control group
Minimal attention waitlist group
干预措施: Brief Eclectic Psychotherapy for PTSD (Behavioral)
结局指标
主要结局
PTSD symptom severity (CAPS, Blake et al. 1998; Post-therapy / post-waitlist comparison, controlled for baseline scores
时间窗: Last month
次要结局
- Comorbidity: Structured Clinical Interview for DSM-IV SCID I (First et al. 1996); Hospital Anxiety and Depression Scale HADS (Zigmond and Snaith 1983)(Last month)
- Questions on Life Satisfaction FLZ (Henrich and Herschbach 2000)(Last month)
- Posttraumatic Growth Inventory PGI (Tedeschi and Calhoun 1996)(Since trauma)
- EEG, event-related potentials: P300(At assessment)
- Posttraumatic Cognitions Inventory PTCI (Foa et al. 1999)(Last month)
- Post-therapy / post-waitlist comparison, follow-up at 6month post therapy(Last month)
- Ability to work and use of health care facilities(Last months)