跳至主要内容
临床试验/NCT02450617
NCT02450617已完成不适用

Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Modum Bad2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Modum Bad
入组人数
158
试验地点
2
主要终点
Global Assessment of Functioning - change from baseline

研究概览

简要总结

The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with Post Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. The investigators also aim to study psychophysiological markers associated with complex trauma and treatment, mechanisms of change involved in treatment, and which patient characteristics that predict positive outcome.

详细描述

Patients with histories of repeated traumatization in childhood often display a wide array of symptoms described as complex traumatic stress disorder. This sequela involves a high degree of comorbid mental and somatic disturbances, and entails tremendous health care costs for society and suffering for the victims. Despite the prevalence and consequences of complex trauma, research on effective treatments is extremely limited. Expert clinicians suggest that initial treatment for these patients should focus on stabilization of symptoms through psychoeducation and skills - training, and some research has supported this advice. Offering such treatment as group therapy can be both cost - effective and give patients additional peer-support. The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with PTSD or dissociative disorders after childhood abuse. This will be investigated in a randomized controlled design. The investigators also aim to discover psychophysiological markers associated with treatment, mechanisms of change involved in treatment, and what patient characteristics that predict outcome. The results may contribute to new knowledge about treatment of complex traumatization, as well as new and improved health services for a vulnerable patient group with little specialized treatment today.

The main aim of this project is to compare the effectiveness of stabilizing group treatment as an add-on to conventional individual therapy, to conventional individual therapy alone, in a randomized controlled design. This will be tested in two independent diagnostic groups: Patients with PTSD and patients with Dissociative disorders, both groups with reports of childhood abuse. The investigators will further investigate how level of dissociative symptoms influence treatment, how group climate influence symptoms, the relationship between individual and group therapy in combined treatment, and how treatment affects Heart Rate Variability. The investigators also seek to evaluate the treatment economically with a societal perspective, carrying out cost-utility analyses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Stabilizing group treatment for PTSD

Experimental

Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment.

干预措施: Conventional individual treatment (Behavioral)

Stabilizing group treatment for PTSD

Experimental

Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment.

干预措施: Stabilizing group treatment for PTSD (Behavioral)

Conventional Individual treatment - PTSD

Active Comparator

Conventional individual treatment.

干预措施: Conventional individual treatment (Behavioral)

Stabilizing group treatment for Dissociative disorders

Experimental

Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment.

干预措施: Conventional individual treatment (Behavioral)

Stabilizing group treatment for Dissociative disorders

Experimental

Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment.

干预措施: Stabilizing group treatment for Dissociative disorders (Behavioral)

Conventional Individual treatment - Dissociative disorders

Active Comparator

Conventional individual treatment.

干预措施: Conventional individual treatment (Behavioral)

结局指标

主要结局

Global Assessment of Functioning - change from baseline

时间窗: 1 week after completed treatment

Daily life functioning and severity of symptoms last week, assessed by interview

Global Assessment of Functioning- change from baseline

时间窗: 6 months after completed treatment

Daily life functioning and severity of symptoms last week, assessed by interview

次要结局

  • Heart rate variability- change from baseline(1 week after completed treatment)
  • PTSD Symptom Scale - Self-Report - change from baseline(6 months after completed treatment)
  • Short Form 36 - change from baseline(6 months after completed treatment)
  • Symptom Checklist 90 Revised - change from baseline(6 months after completed treatment)
  • Inventory of Interpersonal Problems - change from baseline(6 months after completed treatment)
  • Dissociative Experiences Scale II - change from baseline(6 months after completed treatment)
  • Behavior Checklist - change from baseline(6 months after completed treatment)
  • Heart rate variability - change from baseline(6 months after completed treatment)

研究者

发起方
Modum Bad
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验