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

NCT07725588 | Not Yet Recruiting

• 2 other identifiers: NURP-008-25F1I01RD001563-01A2
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress Disorders, Post-Traumatic; Pain, Chronic

Keywords

Meditation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  0, 5, 10, 20 weeks

Secondary Outcomes (2)

• Insomnia Severity Index (ISI)

  0, 5, 10, 20 weeks

• Pre-Sleep Arousal Scale (PSAS)

  0, 5, 10, 20 weeks

Study Arms (2)

mantram repetition program

EXPERIMENTAL

8-session group-based meditation training class led by a trained instructor

Behavioral: Mantram Repetition Program for PTSD + Pain

health education

ACTIVE COMPARATOR

8-session group-based health education and discussion led by a trained instructor

Behavioral: Health Education while Living with Pain

Interventions

Mantram Repetition Program for PTSD + Pain BEHAVIORAL

manualized Mantram Repetition Program adapted for Veterans with PTSD and chronic pain

Also known as: MRP

mantram repetition program

Health Education while Living with Pain BEHAVIORAL

manualized health and wellness psychoeducation and discussion group

Also known as: H.E.L.P.

health education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne L Malaktaris

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne L Malaktaris

CONTACT

(858) 642-3794; anne.malaktaris@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome evaluator is blind to experimental condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)