Posttraumatic Stress DisorderNCT04793698
Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)
A study testing Compassion meditation and Applied relaxation in people with Posttraumatic Stress Disorder, run by Veterans Medical Research Foundation at 3 sites in United States.
Trial summary
Compassion meditation (CM) is a contemplative practice that builds compassion for and connectedness with others. CM has shown promise as a way of enhancing recovery for Veterans with Posttraumatic Stress Disorder (PTSD). 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 and Applied relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 May 2021to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 status
- Able/willing to consent
- Primary complaint of Posttraumatic Stress Disorder (PTSD) or subsyndromal PTSD with accompanying distress and impairment
Who cannot join
- Serious suicidality or homicidality
- Known, untreated substance use or dependence problem
- Untreated/unstable serious mental illness
- Cognitive impairment that would interfere with study activities
- Concurrent enrollment in other treatment for PTSD or other meditation-based practice
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Bedford Healthcare System
Bedford, Massachusetts, 01730
VA Finger Lakes HCS
Canandaigua, New York, 14424-1159
Durham VA Health Care System
Durham, North Carolina, 27705
About this study
Compassion meditation (CM) is a contemplative practice that builds compassion for and connectedness with others. CM has shown promise as a way of enhancing recovery for Veterans with Posttraumatic Stress Disorder (PTSD). The proposed project will examine the feasibility of a clinical trial by assessing our ability to deliver CM and a control intervention consistently with a diverse groups of Veterans from different parts of the country and optimizing the way in which outcomes are determined.
Read the detailed description
Posttraumatic stress disorder (PTSD) is a common health concern among Veterans. Although empirically-supported approaches are widely available, engagement rates are low and partial/non response is common. There has been considerable interest in the role of complementary and alternative interventions for PTSD, but little research is available to guide decisions about care. Compassion meditation (CM), a contemplative practice that is intended to foster connectedness with others, shows promise for the treatment of PTSD in Veterans. In healthy populations, CM fosters positive emotion and social connectedness, both of which are known to enhance coping and resilience in the face of extreme stress. Based on this theoretical rationale, the investigators' recently completed a two-phase proof of concept trial of CM for Veterans with PTSD. The first phase employed qualitative and quantitative procedures to iteratively refine an existing CM protocol for Veterans with PTSD. The second phase utilized a pilot randomized controlled trial to establish the feasibility and acceptability of a randomized trial of CM for Veterans with PTSD and to examine potential clinical impact. On the basis of promising results, this project will evaluate the feasibility of a future multi-site efficacy trial of CM for PTSD.
Although the investigators' prior work is an encouraging first step, key questions remain. First, the investigators' data come from a single site in Southern California. It is possible that there are regional differences in the acceptability of CM, so the investigators plan to examine the feasibility of recruiting and retaining a diverse group of Veterans residing in other areas as well as confirming the acceptability of the approach to this broader group of Veterans. Second, the investigators' previous trial relied on a single therapist, who was actively engaged in the development process. It is important to demonstrate that others can be trained to deliver the approach with fidelity and to have some confidence that results are attributable to the protocol rather than to an individual. Finally, in the interest of ultimately understanding the way in which these interventions lead to symptom change, the investigators' will continue to refine their assessment strategy. If successful, this project will lay the necessary groundwork for an efficacy trial of CM, which ultimately could provide an additional evidence-based treatment option for Veterans with PTSD.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Compassion meditation, Applied relaxation
- Keywords
- Meditation, Compassion meditation, Veterans, Complementary and alternative medicine, PTSD
- 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 meditationOther
10 week meditation course taught in 90-minute groups
Applied relaxationBehavioural
10 week applied relaxation course taught in 90-minute groups
| Study group | Role | What they receive |
|---|---|---|
| Compassion meditation | Experimental | Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity. Receives: Other: Compassion meditation |
| Applied relaxation | Active comparator | Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application. Receives: Behavioral: Applied relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrolment rate
Proportion of consented subjects among all screened and eligible patients.
Measured: 10 weeks
Initiation rate
Proportion of subjects who initiate the intervention among all consented subjects.
Measured: 10 weeks
Per protocol completion rate
Proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.
Measured: 10 weeks
Intent-to-treat completion rate
Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.
Measured: 10 weeks
Credibility
An average of 3 items rated on a Likert scale.
Measured: 10 weeks
Practice time
Number of minutes of practice divided the number of minutes assigned.
Measured: 10 weeks
Participant satisfaction score
Client Satisfaction Questionnaire (CSQ-8) score, an 8-item measure of satisfaction with services received. A total score will be calculated for comparison with normative data and with previous groups.
Measured: 10 weeks
Secondary outcomes (2)
Therapist fidelity to intervention
Percent compliance ("yes" or "no") with whether they addressed items within 3 element types (whether they addressed the elements unique and essential, essential but not unique, proscribed) and overall.
Measured: 10 weeks
Therapist adequacy addressing treatment elements
Likert scale ratings on how well the therapist addressed themes/issues within 3 element types (unique and essential, essential but not unique, proscribed) and overall.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start6 May 2021
- Primary completion30 Sep 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Bedford Research Corporation, Inc., Institute for Medical Research, Inc., National Center for Complementary and Integrative Health (NCCIH), Emory University, Veterans Health Research Institute of Central New York, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793698
- Sponsor's protocol ID
- 0974700
- Other IDs
- U01AT010332
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be available after study completion
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT04793698
- Acronym / sponsor ID
- 0974700
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Meditation, Compassion meditation, Veterans, Complementary and alternative medicine, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- Bedford Research Corporation, Inc., Institute for Medical Research, Inc., National Center for Complementary and Integrative Health (NCCIH), Emory University, Veterans Health Research Institute of Central New York, Inc.
- Study start
- 6 May 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compassion meditation (CM) is a contemplative practice that builds compassion for and connectedness with others. CM has shown promise as a way of enhancing recovery for Veterans with Posttraumatic Stress Disorder (PTSD). The proposed project will examine the feasibility of a clinical trial by assessing our ability to deliver CM and a control intervention consistently with a diverse groups of Veterans from different parts of the country and optimizing the way in which outcomes are determined.
Detailed description
Posttraumatic stress disorder (PTSD) is a common health concern among Veterans. Although empirically-supported approaches are widely available, engagement rates are low and partial/non response is common. There has been considerable interest in the role of complementary and alternative interventions for PTSD, but little research is available to guide decisions about care. Compassion meditation (CM), a contemplative practice that is intended to foster connectedness with others, shows promise for the treatment of PTSD in Veterans. In healthy populations, CM fosters positive emotion and social connectedness, both of which are known to enhance coping and resilience in the face of extreme stress. Based on this theoretical rationale, the investigators' recently completed a two-phase proof of concept trial of CM for Veterans with PTSD. The first phase employed qualitative and quantitative procedures to iteratively refine an existing CM protocol for Veterans with PTSD. The second phase utilized a pilot randomized controlled trial to establish the feasibility and acceptability of a randomized trial of CM for Veterans with PTSD and to examine potential clinical impact. On the basis of promising results, this project will evaluate the feasibility of a future multi-site efficacy trial of CM for PTSD.
Although the investigators' prior work is an encouraging first step, key questions remain. First, the investigators' data come from a single site in Southern California. It is possible that there are regional differences in the acceptability of CM, so the investigators plan to examine the feasibility of recruiting and retaining a diverse group of Veterans residing in other areas as well as confirming the acceptability of the approach to this broader group of Veterans. Second, the investigators' previous trial relied on a single therapist, who was actively engaged in the development process. It is important to demonstrate that others can be trained to deliver the approach with fidelity and to have some confidence that results are attributable to the protocol rather than to an individual. Finally, in the interest of ultimately understanding the way in which these interventions lead to symptom change, the investigators' will continue to refine their assessment strategy. If successful, this project will lay the necessary groundwork for an efficacy trial of CM, which ultimately could provide an additional evidence-based treatment option for Veterans with PTSD.
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 | Other: Compassion meditationCompassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity. |
| Applied relaxation | Active comparator | Behavioral: Applied relaxationVeteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran status
- Able/willing to consent
- Primary complaint of Posttraumatic Stress Disorder (PTSD) or subsyndromal PTSD with accompanying distress and impairment
Key exclusion criteria (5 listed)
- Serious suicidality or homicidality
- Known, untreated substance use or dependence problem
- Untreated/unstable serious mental illness
- Cognitive impairment that would interfere with study activities
- Concurrent enrollment in other treatment for PTSD or other meditation-based practice
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 meditation10 week meditation course taught in 90-minute groups | Other | Compassion meditation |
| Applied relaxation10 week applied relaxation course taught in 90-minute groups | Behavioural | Applied relaxation |
Primary outcome
Enrolment rate
Time frame: 10 weeks
Proportion of consented subjects among all screened and eligible patients.
Initiation rate
Time frame: 10 weeks
Proportion of subjects who initiate the intervention among all consented subjects.
Per protocol completion rate
Time frame: 10 weeks
Proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.
Intent-to-treat completion rate
Time frame: 10 weeks
Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.
Credibility
Time frame: 10 weeks
An average of 3 items rated on a Likert scale.
Practice time
Time frame: 10 weeks
Number of minutes of practice divided the number of minutes assigned.
Participant satisfaction score
Time frame: 10 weeks
Client Satisfaction Questionnaire (CSQ-8) score, an 8-item measure of satisfaction with services received. A total score will be calculated for comparison with normative data and with previous groups.
2 secondary outcomes
Therapist fidelity to intervention
Time frame: 10 weeks
Therapist adequacy addressing treatment elements
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be available after study completion
Related trials for Posttraumatic Stress Disorder
Recruiting
Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center
Traumatic Injury, PTSD
Not yet recruitingPhase 4
Assessing Trauma-related Links Between Affective and Metabolic Systems
Posttraumatic Stress Disorder, Metabolic Syndrome
Not yet recruiting
EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder
Posttraumatic Stress Disorder (PTSD)
Not yet recruiting
Mindful RAVANS Study
mTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder
Not yet recruitingEarly Phase 1
Predictors & Mechanisms of Adolescent PTSD
Posttraumatic Stress Disorder (PTSD), Trauma Exposure
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion meditation and Applied relaxation in people with Posttraumatic Stress Disorder, run by Veterans Medical Research Foundation at 3 sites 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 3 inclusion and 5 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Enrolment rate (time frame: 10 weeks). The study lists 7 primary outcomes in all. 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 30 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.