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

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.

• Mantram Repetition Program for PTSD + Pain (Behavioral), also known as MRP: manualized Mantram Repetition Program adapted for Veterans with PTSD and chronic pain
• Health Education while Living with Pain (Behavioral), also known as H.E.L.P.: manualized health and wellness psychoeducation and discussion group

Primary outcomes

• The Revised Clinician-Administered PTSD scale for DSM-5 (CAPS-5-R) [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) [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.

Secondary outcomes

• Insomnia Severity Index (ISI) [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.
• Pre-Sleep Arousal Scale (PSAS) [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.

Sex: All, ages: 18 Years to any

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

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

NIH grants: I01RD001563