Stress Disorders, Post-TraumaticNCT07725588
Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain
A study testing Mantram Repetition Program for PTSD + Pain and Health Education while Living with Pain in people with Stress Disorders, Post-Traumatic and Pain, Chronic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Approximately 450,000 Veterans Health Administration service users have both posttraumatic stress disorder (PTSD) and chronic pain (CP); treatments that efficiently target both PTSD and CP are limited, and new interventions should address the unique needs of Veterans with PTSD/CP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Pain, Chronic
- What is being tested?
- Mantram Repetition Program for PTSD + Pain and Health Education while Living with Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- U.S. Veteran
- Diagnosis of PTSD
- Chronic, non-malignant pain:
- (a) pain most days (> 3 days/week) for at least 6 months
- (b) average pain severity and interference with enjoyment of life and/or general
- Willing/able to engage in study activities
Who cannot join
- Significant current risk of suicide or homicide
- Untreated severe alcohol or substance use disorder
- Untreated/unstable serious mental health disorders, such as psychotic disorders, bipolar disorder, or serious dissociative symptoms
- Impaired mental status
- Concurrent interventions specifically targeting PTSD or CP or social functioning (e.g., couples therapy) or any meditative or mind-body intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Anne L Malaktaris, (858) 642-3794, anne.malaktaris@va.gov
Anne L Malaktaris
About this study
Official title: Randomized Controlled Trial of Mantram Repetition Program Versus Health and Wellness Psychoeducation for Veterans With Comorbid Posttraumatic Stress Disorder and Chronic Pain
Approximately 450,000 Veterans Health Administration service users have both posttraumatic stress disorder (PTSD) and chronic pain (CP); treatments that efficiently target both PTSD and CP are limited, and new interventions should address the unique needs of Veterans with PTSD/CP. Mantram Repetition Program (MRP), a meditation-based program, appears well-suited to address these high-priority VA needs. MRP has established effectiveness for treatment of PTSD, is broadly acceptable, can be learned quickly and applied flexibly. However, rigorous testing is needed for pain-related outcomes among a PTSD/CP population. The proposed study will include a randomized controlled trial comparing the efficacy of MRP for PTSD/CP to Health Education while Living with Pain among a sample of 170 Veterans with comorbid PTSD/CP. The primary outcomes will be PTSD symptoms and pain interference. Results from this study will directly inform patient care among the nearly 4% of Veterans with PTSD/CP.
Read the detailed description
Posttraumatic stress disorder (PTSD) and chronic, non-malignant pain (CP) are prevalent and costly public health problems, especially among Veterans. Veterans with PTSD/CP utilize more healthcare, have higher rates of insomnia and other psychiatric conditions, increased risk of suicide, worse pain interference, and poorer psychological and social functioning than those with one or neither condition. Mantram Repetition Program (MRP) is a meditation-based treatment that involves silent repetition of a spiritual word combined with one-pointed attention and slowing down. Multiple trials demonstrate that MRP is broadly acceptable, and several randomized controlled trials (RCTs) have supported its efficacy for PTSD in Veterans, primarily via reduced physiological arousal. MRP has not been well-tested among Veterans with CP.
Comorbid PTSD/CP affects approximately 3.8% of US military Veterans (450,000+ VHA service users). Integrative interventions for PTSD/CP are limited, current practices are often disorder-specific and do not confer benefits for all, and innovative treatments are needed to address the unique needs of Veterans with PTSD/CP. Thus, the target population of this study, Veterans with PTSD/CP, is a high priority VA population, and this project is well-aligned with numerous VHA initiatives, including VHA's Whole Health Initiative, Pain Directive, and Pain Management Strategy. Further, MRP is a VA developed product and is readily accessible.
To our knowledge, this is the first RCT of MRP to evaluate CP-related outcomes. In addition, there are currently few evidence-based psychosocial interventions, including complementary and integrative health (CIH) approaches, that efficiently target both PTSD symptoms and CP interference in Veterans. Though the VA has emphasized the relevance of a Whole Health approach to Veteran's health care, there is only one recommended CIH approach for the treatment of both PTSD and CP. Furthermore, much of the current mantra meditation literature is limited by small sample sizes and methodological weaknesses, which are addressed here through randomization, use of adequate control conditions, and other procedures to reduce potential bias (e.g., blinded evaluators).
Specific Aims: (1) To evaluate the efficacy of Mantram Repetition Program for Veterans with comorbid PTSD and CP (MRPPP) compared to Health Education while Living with Pain (H.E.L.P.; health and wellness psychoeducation control) in decreasing PTSD symptom severity and pain interference across study period; (2) to examine hyperarousal and insomnia severity as treatment mechanisms that underpin observed changes in PTSD symptoms and pain interference; (3) evaluate the efficacy of MRPPP vs. H.E.L.P. on exploratory clinical outcomes of interest and potential moderators.
The proposed study is a randomized, controlled phase II trial with longitudinal assessments over a 26-week period at VA San Diego. MRPPP and H.E.L.P. will be delivered via telehealth in eight, 90- minute group intervention sessions among Veterans with PTSD/CP (n = 170). The primary outcomes are PTSD symptom severity and pain interference, assessed at 0, 5, 10, and 20 weeks. Secondary outcomes include mechanisms of treatment effect, including hyperarousal and insomnia severity. Exploratory aims will include additional potential outcomes of interest and moderators of treatment effects.
Findings from the proposed RCT will inform clinical practice and policy by investigating whether Mantram Repetition Program for PTSD + Pain (MRPPP) will improve treatment outcomes for Veterans. MRP is already being applied in multiple other settings, and dissemination and implementation of the adapted product would be straightforward. This work could ultimately lead to better care for Veterans, greater stakeholder satisfaction, and lower costs to VA.
- Conditions
- Stress Disorders, Post-Traumatic, Pain, Chronic
- Being tested
- Mantram Repetition Program for PTSD + Pain, Health Education while Living with Pain
- Keywords
- Meditation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mantram Repetition Program for PTSD + PainBehavioural
Also called MRP
manualized Mantram Repetition Program adapted for Veterans with PTSD and chronic pain
Health Education while Living with PainBehavioural
Also called H.E.L.P.
manualized health and wellness psychoeducation and discussion group
| Study group | Role | What they receive |
|---|---|---|
| mantram repetition program | Experimental | 8-session group-based meditation training class led by a trained instructor Receives: Behavioral: Mantram Repetition Program for PTSD + Pain |
| health education | Active comparator | 8-session group-based health education and discussion led by a trained instructor Receives: Behavioral: Health Education while Living with Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Revised Clinician-Administered PTSD scale for DSM-5 (CAPS-5-R)
The CAPS-5-R is a widely-used, well-validated clinician interview that diagnoses PTSD and assesses the severity of PTSD symptoms. Total severity scores range from 0-200, with higher scores indicated greater severity.
Measured: 0, 5, 10, 20 weeks
Patient Reported Outcome Short Form Pain Interference (PROMIS-PI short form v1.1)
The PROMIS-PI short form is a self-report measure of pain-related functional interference. PROMIS-PI items are self-rated from 1 to 5; responses range from 1 ("not at all") to 5 ("very much"). The PROMIS-PI is psychometrically sound and provides meaningful estimates of change in pain interference in clinical samples.
Measured: 0, 5, 10, 20 weeks
Secondary outcomes (2)
Insomnia Severity Index (ISI)
The ISI is a 7-item self-report measure of the severity and impact of insomnia over the past two weeks. Items are rated from 0 ("no problem") to 4 ("very severe problem"); total ISI scores of 0-7 indicate the absence of clinically significant insomnia, scores from 8-14 indicate subthreshold insomnia, and scores of 15-28 indicate moderate-to-severe insomnia. The ISI has good psychometric properties and is sensitive to changes in perceived sleep difficulties.
Measured: 0, 5, 10, 20 weeks
Pre-Sleep Arousal Scale (PSAS)
The PSAS is a 16-item self-report measure of cognitive and somatic (hyper)arousal occurring before sleep; cognitive arousal symptoms including worrying about sleep, having racing thoughts, and sleep effort, while somatic arousal symptoms include bodily tension/general restlessness and difficulty breathing. PSAS items are rated from 1 ("not at all") to 5 ("extremely"), which are summed to yield two subscale scores ranging from 8 to 40, with higher scores indicated increased arousal before sleep. The PSAS has adequate psychometric properties.
Measured: 0, 5, 10, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Apr 2027 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Model description
- Experimental condition: manualized Mantram Repetition Program protocol, an 8-session group-based meditation training class led by a trained instructor Control condition: manualized health education protocol, an 8-session group-based health education and discussion led by a trained instructor
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anne L Malaktaris, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725588
- Sponsor's protocol ID
- NURP-008-25F
- Other IDs
- 1I01RD001563-01A2
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Specific parameters of sharing are not yet established
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Mantram Repetition Program Versus Health and Wellness Psychoeducation for Veterans With Comorbid Posttraumatic Stress Disorder and Chronic Pain
- ClinicalTrials.gov ID
- NCT07725588
- Acronym / sponsor ID
- NURP-008-25F
- Conditions
- Stress Disorders, Post-Traumatic, Pain, Chronic
- Keywords
- Meditation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 24 Jul 2026 (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.
Approximately 450,000 Veterans Health Administration service users have both posttraumatic stress disorder (PTSD) and chronic pain (CP); treatments that efficiently target both PTSD and CP are limited, and new interventions should address the unique needs of Veterans with PTSD/CP. Mantram Repetition Program (MRP), a meditation-based program, appears well-suited to address these high-priority VA needs. MRP has established effectiveness for treatment of PTSD, is broadly acceptable, can be learned quickly and applied flexibly. However, rigorous testing is needed for pain-related outcomes among a PTSD/CP population. The proposed study will include a randomized controlled trial comparing the efficacy of MRP for PTSD/CP to Health Education while Living with Pain among a sample of 170 Veterans with comorbid PTSD/CP. The primary outcomes will be PTSD symptoms and pain interference. Results from this study will directly inform patient care among the nearly 4% of Veterans with PTSD/CP.
Detailed description
Posttraumatic stress disorder (PTSD) and chronic, non-malignant pain (CP) are prevalent and costly public health problems, especially among Veterans. Veterans with PTSD/CP utilize more healthcare, have higher rates of insomnia and other psychiatric conditions, increased risk of suicide, worse pain interference, and poorer psychological and social functioning than those with one or neither condition. Mantram Repetition Program (MRP) is a meditation-based treatment that involves silent repetition of a spiritual word combined with one-pointed attention and slowing down. Multiple trials demonstrate that MRP is broadly acceptable, and several randomized controlled trials (RCTs) have supported its efficacy for PTSD in Veterans, primarily via reduced physiological arousal. MRP has not been well-tested among Veterans with CP.
Comorbid PTSD/CP affects approximately 3.8% of US military Veterans (450,000+ VHA service users). Integrative interventions for PTSD/CP are limited, current practices are often disorder-specific and do not confer benefits for all, and innovative treatments are needed to address the unique needs of Veterans with PTSD/CP. Thus, the target population of this study, Veterans with PTSD/CP, is a high priority VA population, and this project is well-aligned with numerous VHA initiatives, including VHA's Whole Health Initiative, Pain Directive, and Pain Management Strategy. Further, MRP is a VA developed product and is readily accessible.
To our knowledge, this is the first RCT of MRP to evaluate CP-related outcomes. In addition, there are currently few evidence-based psychosocial interventions, including complementary and integrative health (CIH) approaches, that efficiently target both PTSD symptoms and CP interference in Veterans. Though the VA has emphasized the relevance of a Whole Health approach to Veteran's health care, there is only one recommended CIH approach for the treatment of both PTSD and CP. Furthermore, much of the current mantra meditation literature is limited by small sample sizes and methodological weaknesses, which are addressed here through randomization, use of adequate control conditions, and other procedures to reduce potential bias (e.g., blinded evaluators).
Specific Aims: (1) To evaluate the efficacy of Mantram Repetition Program for Veterans with comorbid PTSD and CP (MRPPP) compared to Health Education while Living with Pain (H.E.L.P.; health and wellness psychoeducation control) in decreasing PTSD symptom severity and pain interference across study period; (2) to examine hyperarousal and insomnia severity as treatment mechanisms that underpin observed changes in PTSD symptoms and pain interference; (3) evaluate the efficacy of MRPPP vs. H.E.L.P. on exploratory clinical outcomes of interest and potential moderators.
The proposed study is a randomized, controlled phase II trial with longitudinal assessments over a 26-week period at VA San Diego. MRPPP and H.E.L.P. will be delivered via telehealth in eight, 90- minute group intervention sessions among Veterans with PTSD/CP (n = 170). The primary outcomes are PTSD symptom severity and pain interference, assessed at 0, 5, 10, and 20 weeks. Secondary outcomes include mechanisms of treatment effect, including hyperarousal and insomnia severity. Exploratory aims will include additional potential outcomes of interest and moderators of treatment effects.
Findings from the proposed RCT will inform clinical practice and policy by investigating whether Mantram Repetition Program for PTSD + Pain (MRPPP) will improve treatment outcomes for Veterans. MRP is already being applied in multiple other settings, and dissemination and implementation of the adapted product would be straightforward. This work could ultimately lead to better care for Veterans, greater stakeholder satisfaction, and lower costs to VA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental condition: manualized Mantram Repetition Program protocol, an 8-session group-based meditation training class led by a trained instructor Control condition: manualized health education protocol, an 8-session group-based health education and discussion led by a trained instructor
| Arm | Type | Receives |
|---|---|---|
| mantram repetition program | Experimental | Behavioral: Mantram Repetition Program for PTSD + Pain8-session group-based meditation training class led by a trained instructor |
| health education | Active comparator | Behavioral: Health Education while Living with Pain8-session group-based health education and discussion led by a trained instructor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- U.S. Veteran
- Diagnosis of PTSD
- Chronic, non-malignant pain:
- Willing/able to engage in study activities
Key exclusion criteria (5 listed)
- Significant current risk of suicide or homicide
- Untreated severe alcohol or substance use disorder
- Untreated/unstable serious mental health disorders, such as psychotic disorders, bipolar disorder, or serious dissociative symptoms
- Impaired mental status
- Concurrent interventions specifically targeting PTSD or CP or social functioning (e.g., couples therapy) or any meditative or mind-body intervention
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 |
|---|---|---|
| Mantram Repetition Program for PTSD + PainAlso: MRPmanualized Mantram Repetition Program adapted for Veterans with PTSD and chronic pain | Behavioural | mantram repetition program |
| Health Education while Living with PainAlso: H.E.L.P.manualized health and wellness psychoeducation and discussion group | Behavioural | health education |
Primary outcome
The Revised Clinician-Administered PTSD scale for DSM-5 (CAPS-5-R)
Time frame: 0, 5, 10, 20 weeks
The CAPS-5-R is a widely-used, well-validated clinician interview that diagnoses PTSD and assesses the severity of PTSD symptoms. Total severity scores range from 0-200, with higher scores indicated greater severity.
Patient Reported Outcome Short Form Pain Interference (PROMIS-PI short form v1.1)
Time frame: 0, 5, 10, 20 weeks
The PROMIS-PI short form is a self-report measure of pain-related functional interference. PROMIS-PI items are self-rated from 1 to 5; responses range from 1 ("not at all") to 5 ("very much"). The PROMIS-PI is psychometrically sound and provides meaningful estimates of change in pain interference in clinical samples.
2 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: 0, 5, 10, 20 weeks
Pre-Sleep Arousal Scale (PSAS)
Time frame: 0, 5, 10, 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. Specific parameters of sharing are not yet established
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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.
Anne L Malaktaris principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mantram Repetition Program for PTSD + Pain and Health Education while Living with Pain in people with Stress Disorders, Post-Traumatic and Pain, Chronic, run by VA Office of Research and Development 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 6 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: opening soon, as of the sponsor's last update on 27 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne L Malaktaris ((858) 642-3794, anne.malaktaris@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Revised Clinician-Administered PTSD scale for DSM-5 (CAPS-5-R) (time frame: 0, 5, 10, 20 weeks). The study lists 2 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 27 Jul 2026.