Yoga and Mantram for Chronic Pain and PTSD
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain, Chronic Pain, Psychiatric, Psychiatric, Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | December 1, 2019 |
| End Date: | May 31, 2021 |
| Contact: | Erik J Groessl, PhD BA BS |
| Email: | Erik.Groessl@va.gov |
| Phone: | (858) 552-8585 |
An Enhanced Mind-body Intervention to Reduce Disability and Pain in Veterans With PTSD
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.
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.
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.
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.
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
We found this trial at
1
site
San Diego, California 92161
Principal Investigator: Erik J. Groessl, PhD BA BS
Phone: 858-552-8585
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