Posttraumatic Stress DisorderNCT02372396
Compassion Meditation for PTSD
A study testing Compassion Meditation (CM) and Relaxation in people with Posttraumatic Stress Disorder, run by Veterans Medical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Compassion Meditation (CM) and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: A Proof of Concept and Feasibility Trial of 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Compassion Meditation (CM), Relaxation
- Keywords
- PTSD, Psychotherapy, Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF), Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Meditation (CM)Behavioural
Also called 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.
RelaxationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Compassion Meditation | Experimental | Compassion Meditation delivered in 10 2-hour group treatment sessions. Receives: Behavioral: Compassion Meditation (CM) |
| Relaxation | Active comparator | Relaxation delivered in 10 2-hour group treatment sessions. Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ariel Lang, PhD, Veterans Medical Research Foundation
- Investigators
- Ariel J Lang, PhD, Principal investigator, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372396
- Sponsor's protocol ID
- H130565
- Other IDs
- 1R34AT007936-01A1
- Status last verified
- Aug 2018
- First submitted
- 3 Feb 2015
- Last updated
- 5 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept and Feasibility Trial of Compassion Meditation for PTSD
- ClinicalTrials.gov ID
- NCT02372396
- Acronym / sponsor ID
- H130565
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Psychotherapy, Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF), Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Posted 5 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compassion Meditation | Experimental | Behavioral: Compassion Meditation (CM)Compassion Meditation delivered in 10 2-hour group treatment sessions. |
| Relaxation | Active comparator | Behavioral: RelaxationRelaxation delivered in 10 2-hour group treatment sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion Meditation (CM)Also: CMCompassion 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. | Behavioural | Compassion Meditation |
| RelaxationRelaxation 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). | Behavioural | Relaxation |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel J Lang, PhD principal investigator
San Diego Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion Meditation (CM) and Relaxation in people with Posttraumatic Stress Disorder, run by Veterans Medical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018; AzTrials last refreshed its copy on 29 Oct 2026.