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Compassion Meditation for PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compassion Meditation (CM)
Relaxation
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Psychotherapy, Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF), Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compassion Meditation

Relaxation

Arm Description

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

Relaxation delivered in 10 2-hour group treatment sessions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 3, 2015
Last Updated
August 5, 2018
Sponsor
Veterans Medical Research Foundation
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02372396
Brief Title
Compassion Meditation for PTSD
Official Title
A Proof of Concept and Feasibility Trial of Compassion Meditation for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Psychotherapy, Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF), Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compassion Meditation
Arm Type
Experimental
Arm Description
Compassion Meditation delivered in 10 2-hour group treatment sessions.
Arm Title
Relaxation
Arm Type
Active Comparator
Arm Description
Relaxation delivered in 10 2-hour group treatment sessions.
Intervention Type
Behavioral
Intervention Name(s)
Compassion Meditation (CM)
Other Intervention Name(s)
CM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation
Intervention Description
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 Outcome Measure Information:
Title
Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity
Description
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
Time Frame
Baseline and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel J Lang, PhD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

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Compassion Meditation for PTSD

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