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Yoga and Mantram for Chronic Pain and PTSD

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ClinicalTrials.gov Identifier: NCT03816007
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Chronic Low Back Pain Chronic Neck Pain Behavioral: Yoga and Mantram Repetition Behavioral: Veteran Calm Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: An Enhanced Mind-body Intervention to Reduce Disability and Pain in Veterans With PTSD
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.
Behavioral: 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.
Other Name: Yoga _+ MR

Active Comparator: Relaxation/Health Education
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
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.
Other Name: VC




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Brief Pain Inventory (BPI) [ Time Frame: Change between baseline and 12-weeks ]
    The short version of the Brief Pain Inventory is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.

  2. 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.

  3. 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.

  4. Short-Form 36 (SF-36) [ Time Frame: Change between baseline and 12-weeks ]
    Health-related Quality of Life will be measured with the SF-36, a descriptive measure providing eight domains of HRQOL. SF-36 norms, reliability and validity are well established. The measure has 8 subscales and 2 summary scales. Each scale score is standardized and thus range from 0-100, with higher scores indicating better health-related quality of life.

  5. 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.

  6. Non-VA Medications/Treatments [ Time Frame: 12-weeks ]
    The investigators will assess medications and self-care treatments used outside of VA via a questionnaire. The data are not scored but are added to VA data to provide a Yes/No indication of whether each participant is using pain medications or treatments at the end of intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816007


Contacts
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Contact: Erik J Groessl, PhD BA BS (858) 552-8585 ext 6347 Erik.Groessl@va.gov
Contact: Tania Zamora, BA (858) 642-3269 tania.zamora@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA Not yet recruiting
San Diego, California, United States, 92161
Contact: Erik J Groessl, PhD BA BS    858-552-8585 ext 6347    Erik.Groessl@va.gov   
Contact: Francisco Atienza    (858) 642-3369    francisco.atienza@va.gov   
Principal Investigator: Erik J. Groessl, PhD BA BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Erik J. Groessl, PhD BA BS VA San Diego Healthcare System, San Diego, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03816007     History of Changes
Other Study ID Numbers: D3009-P
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
PTSD
chronic pain
yoga
mantram repetition
mind-body interventions
complementary and integrative medicine

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Trauma and Stressor Related Disorders
Mental Disorders