跳至主要内容
临床试验/NCT05998967
NCT05998967已完成不适用

Feasibility and Acceptability of Mobile Mantram Repetition Program for Veterans With PTSD (IVI 22-115)

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年12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
入组人数
36
试验地点
2
主要终点
Eligibility Rate

研究概览

简要总结

Mantram Repetition Program (MRP) is a meditation practice that involves silent repetition of a spiritual word, one-pointed attention, and slowing down. It has been shown to help reduce PTSD symptoms among Veterans. This study will look at how Veterans reach to learning MRP via the Internet, either in a self-directed way or with text/phone support.

详细描述

Easily accessible interventions to address post-traumatic stress disorder (PTSD) can play critical role in reducing PTSD and associated symptoms in Veterans, especially for those who remain symptomatic after treatment with other evidence-based interventions, those who prefer complimentary and integrative therapies, or those who have difficulty accessing traditional face-to-face mental health services. The value of these programs is their ability to provide Veterans with more options in their recovery journey and to reach a broad range of Veterans across multiple settings, including remote rural contexts.

The Mantram Repetition Program (MRP) is a meditation-based practice that consists of the repetition of a spiritual word, one-pointed attention, and slowing down. MRP has been shown to reduce stress in several high-risk populations, and two large randomized, controlled studies show that MRP reduces PTSD symptoms among Veterans. A brief, web-based, self-directed version of MRP has been developed to increase the accessibility of evidence-based PTSD treatment. This version of MRP was tested in a pilot study with undergraduate students, demonstrating its ease of use and success in getting students to engage with the practice. The proposed mixed method study will use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to evaluate the mobile MRP in Veterans with PTSD in two conditions: self-directed and with text/phone support. Data from this pilot study will inform the refinement of the MRP delivery strategy and the development of a full-scale trial to test its effectiveness and implementation outcomes, as well as barriers and facilitators, and other contextual factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Primary clinical complaint of PTSD
  • Access to an Internet-enabled device

排除标准

  • Cognitive impairment or mental health concerns that necessitated a higher level of care or interfered with ability to engage in study activities

研究组 & 干预措施

Self-directed MRP

Experimental

Self-directed instruction in MRP via Internet

干预措施: Mobile Mantram Repetition Program (Behavioral)

Supported MRP

Active Comparator

Supported instruction in MRP via Internet

干预措施: Mobile Mantram Repetition Program (Behavioral)

结局指标

主要结局

Eligibility Rate

时间窗: Day 0

Rate of eligibility among those screened for participation

Acceptability of Intervention Measure (AIM)

时间窗: Day 28

Perceived acceptability of the intervention as measured by an AIM average score. Scores range from 1-5 with higher scores indicating greater acceptability.

Initiation Rate

时间窗: Day 1

Rate of intervention initiation among eligible Veterans

Completion Rate

时间窗: Day 28

Rate of intervention completion among eligible Veterans

Credibility

时间窗: Day 1

Average Veteran perception of the logic, utility and expected benefit of treatment rated on a scale of 0 (not at all) to 8 (very)

Abbreviated Client Satisfaction Questionnaire (CSQ-8)

时间窗: Day 28

Degree of satisfaction with care received as measured by 4 items from the CSQ-8, creating a 4-item total score. Scores range from 4-16 with higher scores indicating greater satisfaction.

Intervention Appropriateness Measure (IAM)

时间窗: Day 28

Perceived appropriateness of the intervention as measured by an IAM average score. Scores range from 1-5 with higher scores indicating greater appropriateness.

Feasibility of Intervention Measure (FIM)

时间窗: Day 28

Perceived feasibility of the intervention as measured by an FIM average score. Scores range from 1-5 with higher scores indicating greater feasibility.

次要结局

  • Mantram Practice(Day 28)
  • PTSD Checklist for DSM-5 (PCL-5)(Day 28)
  • Patient Health Questionnaire Depression Items (PHQ-9)(Day 28)
  • Insomnia Severity Index(Day 28)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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