Yoga and Mantram for Chronic Pain and PTSD

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Traumatic Stress Disorder Chronic Low Back Pain Chronic Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants are blinded to which intervention is hypothesized to be superior, but are aware of the intervention they are assigned to. All assessments are self-report and do not require interpretation by study investigators.

Study Groups

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Yoga and Mantram Repetition

An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.

Group Type EXPERIMENTAL

Yoga and Mantram Repetition

Intervention Type BEHAVIORAL

An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.

Relaxation/Health Education

A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.

Group Type ACTIVE_COMPARATOR

Veteran Calm

Intervention Type BEHAVIORAL

A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.

Interventions

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Yoga and Mantram Repetition

An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.

Intervention Type BEHAVIORAL

Veteran Calm

A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.

Intervention Type BEHAVIORAL

Other Intervention Names

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Yoga _+ MR VC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No