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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
What is being tested?
Mantram Repetition Program for PTSD + Pain and Health Education while Living with Pain
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.

Anne L Malaktaris contact

(858) 642-3794

anne.malaktaris@va.gov

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

Other trials in United States

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.

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 groups in NCT07725588
Study groupRoleWhat they receive
mantram repetition programExperimental8-session group-based meditation training class led by a trained instructor
Receives: Behavioral: Mantram Repetition Program for PTSD + Pain
health educationActive comparator8-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.

  1. 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

  2. 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)
  1. 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

  2. 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.

  1. First posted24 Jul 2026
  2. Study start1 Apr 2027 (estimated)
  3. Primary completion1 Apr 2030 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

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)
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

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; AzTrials last refreshed its copy on 8 Nov 2026.

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