Yoga and Mantram for Chronic Pain and PTSD
An Enhanced Mind-body Intervention to Reduce Disability and Pain in Veterans With PTSD
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedResults Posted
Study results publicly available
October 31, 2023
CompletedOctober 31, 2023
October 1, 2023
10 months
January 17, 2019
December 16, 2022
October 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Roland-Morris Disability Questionnaire (RMDQ)
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 Outcomes (7)
BPI Pain Severity
change from baseline to 12 weeks
Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5)
Change between baseline and 12-weeks
BPI Pain Interference
change from baseline to 12 weeks
Insomnia Severity Index (ISI)
Change between baseline and 12-weeks
Quality of Life - EQ5D
Change between baseline and 12-weeks
- +2 more secondary outcomes
Study Arms (2)
Yoga and Mantram Repetition
EXPERIMENTALAn 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
ACTIVE COMPARATORA relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Erik Groessl
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Erik J. Groessl, PhD BA BS
VA San Diego Healthcare System, San Diego, CA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2019
First Posted
January 25, 2019
Study Start
April 1, 2021
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
October 31, 2023
Results First Posted
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available within 12 months of the end of the study.
- Access Criteria
- 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.
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.