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临床试验/NCT01464892
NCT01464892已完成不适用

Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma

University of Amsterdam1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2011年10月1日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early, chronic, interpersonal trauma (e.g. Smucker & Dancu, 1999). So far, this protocol has not been investigated within a controlled setting with patients with PTSD following early, chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can be improved by adding a stabilization phase (Skills training in affective and interpersonal regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions will be compared:

  1. Imagery Rescripting
  2. STAIR + Imagery Rescripting
  3. Wait-list control

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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
否

入选标准

  • •a full diagnosis of post-traumatic stress disorder (PTSD) according to DSM-IV
  • •having experienced repeated or chronic interpersonal trauma by care-takers or authority figures before the age of 15
  • •between the age of 18 and 65 years
  • •sufficient fluency of Dutch to complete treatment and research-protocol
  • •participants using prescribed anti-depressant medication are required to be on a stable dose for at least 6 weeks before the beginning of treatment and remain on this dose throughout the treatment

排除标准

  • •psychosis
  • •bipolar disorder
  • •significant cognitive impairment
  • •substance dependence
  • •current use of benzodiazepines
  • •severe suicidal ideation or life-threatening automutilation
  • •current trauma or threat
  • •unstable living circumstances
  • •antisocial personality disorder
  • •primary diagnosis of borderline personality disorder

研究组 & 干预措施

Imagery Rescripting

Experimental

干预措施: Imagery Rescripting and Reprocessing Therapy (Behavioral)

STAIR plus Imagery Rescripting

Active Comparator

干预措施: STAIR + Imagery Rescripting (Behavioral)

Wait-list control

No Intervention

Participants from this arm are randomized to the two active conditions after 8 weeks of waiting.

结局指标

主要结局

Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks

时间窗: baseline and 8 weeks

comparison STAIR vs ImRs vs WL

Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks

时间窗: baseline and 8 weeks

comparison STAIR vs ImRs vs WL

次要结局

  • Post-treatment: Change from Baseline in Beck Depression Inventory (BDI) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR).(baseline and max 24 weeks (depending on condition))
  • Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks(baseline and 8 weeks)
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks(baseline and 8 weeks)
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks(baseline and 8 weeks)
  • Posttreatment: Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs 24 weeks (WL/STAIR/ImRs)(baseline and max.24 weeks (depending on condition))
  • Post-treatment: Change from Baseline in Inventory of Interpersonal Problems (IIP) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR).(baseline and max 24 weeks (depending on condition))
  • 12-week FU: Change from Baseline in Inventory of Interpersonal Problems (IIP) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).(baseline and max 36 weeks (depdending on condition))
  • Post-treatment: Change from Baseline in Dissociation Questionnaire (DIS-Q) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)(baseline and max 24 weeks (depending on condition))
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks(baseline and 8 weeks)
  • 12-week fu: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR)./ImRs).(baseline and max. 36 weeks (depending on condition))
  • Post-treatment: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR(baseline and max 24 weeks (depending on condition))
  • Post-treatment: Change from Baseline in WHO-Quality of Life(WHO-QL) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)(baseline and max 24 weeks (depending on condition))
  • 12-week FU: Change from Baseline in WHO-Quality of Life(WHO-QL) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).(baseline and max 36 weeks (depdending on condition))
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks(baseline and 8 weeks)
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks(baseline and 8 weeks)
  • 12-week FU: Change from Baseline in Dissociation Questionnaire (DIS-Q) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).(baseline and max 36 weeks (depdending on condition))
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks(baseline and 8 weeks)
  • 12-week follow-up: Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR/ImRs).(baseline and max. 36 weeks (depending on condition))
  • Post-treatment: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR/ImRs)(baseline and max.24 weeks (depending on condition))
  • 12-week FU: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).(baseline and max 36 weeks (depdending on condition))
  • 12-week FU: Change from Baseline in Difficulties in Emotion Regulation Scale (DERS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).(baseline and max 36 weeks (depdending on condition))
  • Change from Baseline in Beck Depression Inventory (BDI) at 20 weeks (ImRs) vs 12-week-fu: 8 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).(baseline and max 36 weeks (depending on condition))
  • Post-treatment: Change from Baseline in Difficulties in Emotion Regulation Scale Post-treatment: Change from Difficulties in Emotion Regulation Scale (DERS) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)(baseline and max 24 weeks (depending on condition))
  • Post-treatment: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)(baseline and max 36 weeks (depdending on condition))
  • 12-week FU: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).(baseline and max 36 weeks (depdending on condition))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mrs. M. Kindt

Professor of Experimental and Clinical Psychology

University of Amsterdam

研究点 (1)

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