跳至主要内容
临床试验/NCT04793698
NCT04793698已完成不适用

Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)

Veterans Medical Research Foundation3 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2021年5月6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
113
试验地点
3
主要终点
Initiation rate

研究概览

简要总结

Compassion meditation (CM) is a contemplative practice that builds compassion for and connectedness with others. CM has shown promise as a way of enhancing recovery for Veterans with Posttraumatic Stress Disorder (PTSD). The proposed project will examine the feasibility of a clinical trial by assessing our ability to deliver CM and a control intervention consistently with a diverse groups of Veterans from different parts of the country and optimizing the way in which outcomes are determined.

详细描述

Posttraumatic stress disorder (PTSD) is a common health concern among Veterans. Although empirically-supported approaches are widely available, engagement rates are low and partial/non response is common. There has been considerable interest in the role of complementary and alternative interventions for PTSD, but little research is available to guide decisions about care. Compassion meditation (CM), a contemplative practice that is intended to foster connectedness with others, shows promise for the treatment of PTSD in Veterans. In healthy populations, CM fosters positive emotion and social connectedness, both of which are known to enhance coping and resilience in the face of extreme stress. Based on this theoretical rationale, the investigators' recently completed a two-phase proof of concept trial of CM for Veterans with PTSD. The first phase employed qualitative and quantitative procedures to iteratively refine an existing CM protocol for Veterans with PTSD. The second phase utilized a pilot randomized controlled trial to establish the feasibility and acceptability of a randomized trial of CM for Veterans with PTSD and to examine potential clinical impact. On the basis of promising results, this project will evaluate the feasibility of a future multi-site efficacy trial of CM for PTSD.

Although the investigators' prior work is an encouraging first step, key questions remain. First, the investigators' data come from a single site in Southern California. It is possible that there are regional differences in the acceptability of CM, so the investigators plan to examine the feasibility of recruiting and retaining a diverse group of Veterans residing in other areas as well as confirming the acceptability of the approach to this broader group of Veterans. Second, the investigators' previous trial relied on a single therapist, who was actively engaged in the development process. It is important to demonstrate that others can be trained to deliver the approach with fidelity and to have some confidence that results are attributable to the protocol rather than to an individual. Finally, in the interest of ultimately understanding the way in which these interventions lead to symptom change, the investigators' will continue to refine their assessment strategy. If successful, this project will lay the necessary groundwork for an efficacy trial of CM, which ultimately could provide an additional evidence-based treatment option for Veterans with PTSD.

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)

盲法说明

Blinded to intervention arm

入排标准

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

入选标准

  • •Veteran status
  • •Able/willing to consent
  • •Primary complaint of Posttraumatic Stress Disorder (PTSD) or subsyndromal PTSD with accompanying distress and impairment

排除标准

  • •Serious suicidality or homicidality
  • •Known, untreated substance use or dependence problem
  • •Untreated/unstable serious mental illness
  • •Cognitive impairment that would interfere with study activities
  • •Concurrent enrollment in other treatment for PTSD or other meditation-based practice

研究组 & 干预措施

Applied relaxation

Active Comparator

Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application.

干预措施: Applied relaxation (Behavioral)

Compassion meditation

Experimental

Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.

干预措施: Compassion meditation (Other)

结局指标

主要结局

Initiation rate

时间窗: 10 weeks

Proportion of subjects who initiate the intervention among all consented subjects.

Credibility

时间窗: 10 weeks

An average of 3 items rated on a Likert scale.

Intent-to-treat completion rate

时间窗: 10 weeks

Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.

Practice time

时间窗: 10 weeks

Number of minutes of practice divided the number of minutes assigned.

Enrolment rate

时间窗: 10 weeks

Proportion of consented subjects among all screened and eligible patients.

Per protocol completion rate

时间窗: 10 weeks

Proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.

Participant satisfaction score

时间窗: 10 weeks

Client Satisfaction Questionnaire (CSQ-8) score, an 8-item measure of satisfaction with services received. A total score will be calculated for comparison with normative data and with previous groups.

次要结局

  • Therapist adequacy addressing treatment elements(10 weeks)
  • Therapist fidelity to intervention(10 weeks)

研究者

发起方
Veterans Medical Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验