Clinical trial NCT03816007: Yoga and Mantram for Chronic Pain and PTSD
Official title: An Enhanced Mind-body Intervention to Reduce Disability and Pain in Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Chronic Low Back Pain
Chronic Neck Pain
Keywords: PTSD
chronic pain
yoga
mantram repetition
mind-body interventions
complementary and integrative medicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-01-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomized to either the enhanced yoga interventions or the (R/HE) comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework assignments will be included.
Primary purpose: TREATMENT

Brief summary: PTSD is prevalent among Veterans and is associated with physical and functional impairments in addition to PTSD symptoms. Veterans with PTSD experience more chronic pain and pain-related functional limitations than Veterans without PTSD. Mind-body interventions such as yoga and meditation are non-pharmacological options for treating both chronic pain and PTSD. This pilot study will add an existing mantram repetition (MR) component designed for Veterans with PTSD to an active yoga intervention known to improve function in chronic back pain patients. The study will examine the acceptability of the interventions, adverse events, and the feasibility of recruitment, attendance, retention, treatment fidelity, and assessments by recruiting and randomizing 32 VA patients with PTSD to either yoga plus MR or to a relaxation/health education control. Health outcomes including pain-related function, pain, and PTSD symptoms will be measured. If feasible, the data will be used to plan a full-scale trial of enhanced yoga for pain in VA patients with PTSD.

Detailed description: The objectives of the proposed project are to examine the feasibility of delivering a combined yoga and MR intervention to VA patients with PTSD and cLBP and/or cNP within a randomized controlled trial study design. MR enhances the active yoga intervention for this specific population by providing a portable tool for managing stress and anxiety, and improving mental and emotional functioning in situations of daily life. The investigators will recruit and randomize 32 Veterans with PTSD to either enhanced yoga interventions or a relaxation/health education (R/HE) comparison intervention. The goal of the pilot randomized trial is to demonstrate the acceptability of the interventions, to study the feasibility of recruitment, retention, adherence, randomization, and assessments with military Veterans with PTSD, and to measure any adverse events. Data will inform plans for a full-scale effectiveness RCT.

Researchers and content experts will adapt and blend two manualized interventions (MR and yoga) into a single manualized and acceptable intervention. In addition, the existing yoga intervention and MR manuals will be adapted to provide a structured intervention guide for instructors. Next, the investigators will recruit and screen 32 Veterans with PTSD. Eligible participants will be randomized to either the enhanced yoga interventions or the (R/HE) comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework assignments will be included. The investigators will track and measure adverse events, recruitment rates, attendance and home practice rates, use of MR and yoga principles in daily life, attrition rates, and time to complete assessments. Questionnaires will assess pain-related function, pain, PTSD symptoms, insomnia/sleep, alcohol use, and quality of life. The investigators will also conduct qualitative interviews with 12 study participants to examine acceptability, recommendations, and factors affecting attendance and attrition. The investigators will target 7-8 yoga participants and 4-5 control participants. Data will be used to plan a full-scale RCT powered to detect differences in health outcomes.

Eligibility criteria: Inclusion Criteria:

* Veterans Affairs (VA) patients
* age \> 18
* current diagnosis of PTSD
* score of 25 on Montreal Cognitive Assessment (MoCA)
* willing to reduce or cease opioid medications
* willing to attend 12-weeks of mind-body interventions and complete 3 assessments

Exclusion Criteria:

* serious or unstable psychiatric illness

  * e.g. psychosis, mania
* suicidal or homicidal ideation
* \< 3 months since major trauma event
* moderate or severe cognitive impairment
* practiced yoga or mantram repetition \> 2x in the last 6 months
* coexisting medical illness with yoga contraindicated

Primary outcomes:
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Change between baseline and 12-weeks
Secondary outcomes:
measure: BPI Pain Severity
timeFrame: change from baseline to 12 weeks
measure: Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5)
timeFrame: Change between baseline and 12-weeks
measure: BPI Pain Interference
timeFrame: change from baseline to 12 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: Change between baseline and 12-weeks
measure: Quality of Life - EQ5D
timeFrame: Change between baseline and 12-weeks
measure: AUDIT-C
timeFrame: Change between baseline and 12-weeks
measure: Fatigue
timeFrame: change from baseline to 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Erik J. Groessl, PhD BA BS
role: PRINCIPAL_INVESTIGATOR
References: