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Compassion Meditation for PTSD

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ClinicalTrials.gov Identifier: NCT02372396
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Ariel Lang, PhD, Veterans Medical Research Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Compassion Meditation (CM) Behavioral: Relaxation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof of Concept and Feasibility Trial of Compassion Meditation for PTSD
Actual Study Start Date : February 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : June 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Compassion Meditation
Compassion Meditation delivered in 10 2-hour group treatment sessions.
 Behavioral: Compassion Meditation (CM)
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 Name: CM
Active Comparator: Relaxation
Relaxation delivered in 10 2-hour group treatment sessions.
 Behavioral: Relaxation
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).


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372396


Locations
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United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Ariel J Lang, PhD San Diego Veterans Healthcare System
  Study Documents (Full-Text)

Documents provided by Ariel Lang, PhD, Veterans Medical Research Foundation:
Study Protocol and Statistical Analysis Plan  [PDF] September 15, 2014

More Information
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Responsible Party: Ariel Lang, PhD, Research Psychologist, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02372396    
Other Study ID Numbers: H130565
1R34AT007936-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2015    Key Record Dates
Results First Posted: September 5, 2018
Last Update Posted: September 5, 2018
Last Verified: August 2018
Keywords provided by Ariel Lang, PhD, Veterans Medical Research Foundation:
PTSD
Psychotherapy
Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)
Veterans
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders