跳至主要内容
临床试验/NCT02372396
NCT02372396已完成不适用

A Proof of Concept and Feasibility Trial of Compassion Meditation for PTSD

Veterans Medical Research Foundation2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2015年2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
37
试验地点
2
主要终点
Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity

研究概览

简要总结

The goal of this project is to refine an existing compassion meditation protocol for individuals with posttraumatic stress disorder (PTSD), to examine the safety and feasibility of this approach and to collect data to make initial estimates of efficacy.

详细描述

There is considerable public and professional interest in complementary and alternative approaches, including meditation, for managing posttraumatic stress disorder (PTSD), but there is little empirical support to guide their use. Multiple meditative techniques can be applied to the amelioration of this disorder, and the literature suggests that they operate by different mechanisms. Compassion meditation is a meditative practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness.

Compassion meditation has not been evaluated for use with PTSD patients; therefore, the goal of this project is to refine an existing compassion meditation protocol for individuals with PTSD, to examine the safety and feasibility of this approach and to collect data to make initial estimates of efficacy. The proposed project will be completed in two phases.

In phase one, the compassion meditation protocol will be executed with individuals with PTSD and iteratively refined based on therapist and participant feedback. In addition, a relaxation protocol that was used in a previous PTSD trial will be modified to match the length and format of the meditative practice.

In phase two, the investigators will complete a pilot study to examine the feasibility of conducting a randomized trial comparing these interventions and to provide information that will allow us to better design future projects. Ultimately, the research informed by this project may provide an additional option for treatment of PTSD, which would be an important contribution because existing treatment approaches are not universally acceptable or effective.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veteran of at least 18 years of age
  • PTSD as defined by the Diagnostic and Statistical Manual Version 5 (DSM-5)
  • Capacity to consent
  • Willing to commit to 8 consecutive weekly sessions lasting 2 hours in duration and to complete assessment materials.

排除标准

  • Serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months
  • A known, untreated substance use disorder (inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem)
  • Serious Axis I mental disorders, such as psychotic disorders or bipolar type I, or serious dissociative symptoms
  • Cognitive impairment that would interfere with consent or treatment
  • Circumstances that lead to recurrent traumatization (e.g., engaged in a violent relationship)
  • Concurrent enrollment in any other treatment specifically targeting PTSD symptoms or social functioning (e.g., couples therapy)

研究组 & 干预措施

Compassion Meditation

Experimental

Compassion Meditation delivered in 10 2-hour group treatment sessions.

干预措施: Compassion Meditation (CM) (Behavioral)

Relaxation

Active Comparator

Relaxation delivered in 10 2-hour group treatment sessions.

干预措施: Relaxation (Behavioral)

结局指标

主要结局

Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity

时间窗: Baseline and 10 weeks

Clinical interview that quantifies PTSD symptomatology according to DSM-5, generating a continuous measure of severity (range 0-80) where higher scores indicate more symptomatology

次要结局

未报告次要终点

研究者

发起方
Veterans Medical Research Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ariel Lang, PhD

Research Psychologist

Veterans Medical Research Foundation

研究点 (2)

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