Compassion Meditation for PTSD

NCT ID: NCT02372396

Last Updated: 2018-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Compassion Meditation

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

Group Type EXPERIMENTAL

Compassion Meditation (CM)

Intervention Type 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.

Relaxation

Relaxation delivered in 10 2-hour group treatment sessions.

Group Type ACTIVE_COMPARATOR

Relaxation

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

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CM

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Ariel Lang, PhD

Research Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ariel J Lang, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego Veterans Healthcare System

Locations

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VA San Diego Healthcare System

San Diego, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R34AT007936-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H130565

Identifier Type: -

Identifier Source: org_study_id

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