Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
U.S. Veteran
Diagnosis of PTSD
(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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mantram Repetition Program for PTSD + Pain
Behavioralmanualized Mantram Repetition Program adapted for Veterans with PTSD and chronic pain
Health Education while Living with Pain
Behavioralmanualized health and wellness psychoeducation and discussion group
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: mantram repetition programExperimental treatment 1 intervention
Group B: health educationActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
0, 5, 10, 20 weeks2
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.
Time frame
0, 5, 10, 20 weeksSecondary outcomes
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.
Time frame
0, 5, 10, 20 weeks2
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.
Time frame
0, 5, 10, 20 weeksSponsors and contacts
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Source ClinicalTrials.gov
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