RCT of Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain

July 21, 2026 updated by: VA Office of Research and Development

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA
        • Contact:
        • Principal Investigator:
          • Anne L Malaktaris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mantram repetition program
8-session group-based meditation training class led by a trained instructor
Behavioral: Mantram Repetition Program for PTSD + Pain
manualized Mantram Repetition Program adapted for Veterans with PTSD and chronic pain
Other Names:
  • MRP
Active Comparator: health education
8-session group-based health education and discussion led by a trained instructor
Behavioral: Health Education while Living with Pain
manualized health and wellness psychoeducation and discussion group
Other Names:
  • H.E.L.P.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 5, 10, 20 weeks
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.
0, 5, 10, 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: 0, 5, 10, 20 weeks
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.
0, 5, 10, 20 weeks
Pre-Sleep Arousal Scale (PSAS)
Time Frame: 0, 5, 10, 20 weeks
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.
0, 5, 10, 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Anne L Malaktaris, VA San Diego Healthcare System, San Diego, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NURP-008-25F
  • 1I01RD001563-01A2 (Other Grant/Funding Number: VA Office of Research and Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Specific parameters of sharing are not yet established

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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