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临床试验/NCT02236377
NCT02236377已完成不适用

Exposure, Relaxation, Rescripting Therapy (ERRT) Dismantling

University of Tulsa3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
3
主要终点
Nightmare Frequency Past Week

研究概览

简要总结

The purpose of this case series dismantling study is to extend previous findings regarding the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose effect and mechanism of change.

Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. ERRT has exhibited strong support in reducing the frequency and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. In addition, significant decreases in PTSD and depression symptoms have been reported following treatment (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, & Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis, Rhudy, & Favorite, 2011).

Despite this evidence, the mechanism of change for ERRT remains unclear. We propose to conduct a set of case series in order to examine the possible mechanisms: psycho-education, dose response for exposure, and no exposure components of the treatment. Each part of the treatment is theorized to contribute to the improved treatment outcome and it is hypothesized that participants will benefit no matter what group they are in. All participants will receive 5 to 6 treatment sessions, conducted once per week for about 90 minutes, of a modified version of ERRT.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older at the time of the intake,
  • experienced a traumatic event, as defined by the Diagnostic and Statistical Manual (DSM-5),
  • have approximately one nightmare each week for the past month
  • be able to read and speak English.

排除标准

  • age of 17 or younger
  • acute or apparent psychosis
  • unmedicated bipolar disorder
  • intellectual disability
  • active suicidality,
  • recent parasuicidal behaviors
  • untreated substance use disorder in past 6 months

研究组 & 干预措施

ERRT - Enhanced Exposure

Active Comparator

Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced exposure techniques

干预措施: Exposure, Relaxation, and Rescripting Therapy (Behavioral)

ERRT - Sleep and Relaxation

Active Comparator

Exposure, Relaxation, and Rescripting Therapy protocol, 5 sessions, focused on sleep and relaxation

干预措施: Exposure, Relaxation, and Rescripting Therapy (Behavioral)

ERRT-Rescription

Active Comparator

Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with rescription but no exposure

干预措施: Exposure, Relaxation, and Rescripting Therapy (Behavioral)

ERRT-Sleep

Active Comparator

Exposure, Relaxation, and Rescripting Therapy, 5 sessions, with enhanced sleep techniques

干预措施: Exposure, Relaxation, and Rescripting Therapy (Behavioral)

ERRT - Consensus Manual

Active Comparator

Consensus Protocol, 6 sessions, includes components of ERRT and other nightmare protocols.

干预措施: Exposure, Relaxation, and Rescripting Therapy (Behavioral)

结局指标

主要结局

Nightmare Frequency Past Week

时间窗: up to 6 months followup

This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).

次要结局

未报告次要终点

研究者

发起方
University of Tulsa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne Davis

Associate Professor

University of Tulsa

研究点 (3)

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