Mantram Repetition for PTSD

AL
Overseen ByAnne L Malaktaris
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AL

Anne L Malaktaris

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for U.S. veterans who have both PTSD and chronic, non-cancer pain that affects their daily life and has lasted at least 6 months. Participants must be able to join study activities. People with untreated severe substance use, serious mental illness, high suicide risk, or those already in similar therapies can't take part.

Inclusion Criteria

U.S. Veteran
I have ongoing non-cancer pain that affects my daily life or enjoyment.
Willing and able to engage in study activities
See 2 more

Exclusion Criteria

Untreated severe alcohol or substance use disorder
Untreated or unstable serious mental health disorders such as psychotic disorders, bipolar disorder, or serious dissociative symptoms
Significant current risk of suicide or homicide
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Mantram Repetition Program or Health Education in eight 90-minute group sessions delivered via telehealth

8 weeks
8 group sessions (telehealth)

Follow-up

Participants are monitored for PTSD symptom severity and pain interference at multiple time points

18 weeks
Assessments at 0, 5, 10, and 20 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Health Education while Living with Pain
  • Mantram Repetition Program for PTSD + Pain

Trial Overview

The study compares two group programs: a meditation-based Mantram Repetition Program (MRP) designed to help with PTSD and pain, versus health education sessions about living with pain. Veterans are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: mantram repetition programExperimental Treatment1 Intervention
Group II: health educationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+