- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03816007
Yoga and Mantram for Chronic Pain and PTSD
An Enhanced Mind-body Intervention to Reduce Disability and Pain in Veterans With PTSD
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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San Diego, California, United States, 92161
- VA San Diego Healthcare System, San Diego, CA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
Active Comparator: Relaxation/Health Education
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: Change between baseline and 12-weeks
|
The RMDQ has 23 questions asking about limitations experienced with daily activities.
The scale is reliable and well validated.
It has been used in other yoga studies.
Scores can range from 0-24.
Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.
The scale has been shown to be reliable and is well validated.
It has been used in another yoga RCT, allowing for comparisons.
|
Change between baseline and 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index (ISI)
Time Frame: Change between baseline and 12-weeks
|
Insomnia Severity Index is a 7-item instrument that assesses the impact of insomnia.
Each question is rated on a scale from 0-4 and the total score ranges from 0-28 with higher scores indicating a greater severity of insomnia.
|
Change between baseline and 12-weeks
|
AUDIT-C
Time Frame: Change between baseline and 12-weeks
|
AUDIT-C is a 3-item screen for problem drinking and will refer to alcohol use over the past 3-month period.
The measure has questions on typical consumption and binge drinking frequency.
Each question is rated on a scale from 0-4 and the total score ranges from 0-12 with higher scores indicating a greater likelihood of alcohol use problems.
|
Change between baseline and 12-weeks
|
BPI Pain Severity
Time Frame: change from baseline to 12 weeks
|
Brief Pain Inventory Pain Severity - The total score is the mean of the 4 pain severity items.
Scores range from 0-10 with higher scores indicating greater pain severity.
|
change from baseline to 12 weeks
|
Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5)
Time Frame: Change between baseline and 12-weeks
|
The PCL-5 is a 20-item self-report measure assessing 20 DSM-5 symptoms of PTSD.
Each question is rated on a scale from 0-4 and the total score ranges from 0-80 with higher scores indicating a greater severity of PTSD symptoms.
|
Change between baseline and 12-weeks
|
BPI Pain Interference
Time Frame: change from baseline to 12 weeks
|
Brief Pain Inventory Pain Interference - The total score is the mean of the 7 pain interference items.
Scores range from 0-10 with higher scores indicating greater pain interference.
|
change from baseline to 12 weeks
|
Quality of Life - EQ5D
Time Frame: Change between baseline and 12-weeks
|
Health-related Quality of Life will be measured with the EQ5D-3L.
Scores range from 0 to 1.0 with higher scores indicating better quality of life.
|
Change between baseline and 12-weeks
|
Fatigue
Time Frame: change from baseline to 12 weeks
|
Fatigue Severity Scale - The scale consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63.
Higher scores reflect greater fatigue severity and less energy.
|
change from baseline to 12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Erik J. Groessl, PhD BA BS, VA San Diego Healthcare System, San Diego, CA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3009-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
A de-identified, anonymized dataset will be created and shared. Requests for access to this data must be made in writing signed by a requestor from the United States. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. Should the investigator leave the VASDHS the requests may be sent to the VA San Diego Associate Chief of Staff for Research.
One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study and therefore sufficient to reproduce or verify any published findings. Publications will specify the statistical analytic methods used, thereby enabling recipients to analyze the same data and validate study results.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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