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Completed

NCT Number: NCT02372396

Compassion Meditation for PTSD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Compassion Meditation (CM)

Behavioral

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.

Other names: CM

Relaxation

Behavioral

Relaxation Training is selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, in session and at home exercises).

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Feb 26, 2015
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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