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Meditation in Veterans With PTSD and Mild TBI

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ClinicalTrials.gov Identifier: NCT02280304
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Palo Alto University
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE October 17, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date March 29, 2018
Actual Study Start Date  ICMJE November 3, 2014
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
Clinician-Administered PTSD Scale (CAPS5) [ Time Frame: 12 weeks ]
Changes in responses in the CAPS5 will be measured in patients following meditation or control
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
Changes in responses to the Clinician-Administered PTSD Scale in patients following meditation or control [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT02280304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • Changes in resting state functional connectivity in patients following meditation or control [ Time Frame: 12 weeks ]
    Functional connectivity will be measured between the Default Mode Network and lateral prefrontal cortex, and between the rostral anterior cingulate and amygdala
  • Community Reintegration in Service Members (CRIS) [ Time Frame: 12 weeks ]
    Changes in responses to the Community Reintegration in Service Members questionnaire in patients following meditation or control
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
  • Changes in resting state functional connectivity in patients following meditation or control [ Time Frame: 12 weeks ]
    Functional connectivity will be measured between the Default Mode Network and lateral prefrontal cortex, and between the rostral anterior cingulate and amygdala
  • Changes in responses to the Community Reintegration in Service Members questionnaire in patients following meditation or control [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Meditation in Veterans With PTSD and Mild TBI
Official Title  ICMJE Neuroimaging Meditation Therapy in Veterans With Co-Morbid TBI and PTSD
Brief Summary

The goal of this study is to learn more about how Inner Resources for Veterans (IRV) meditation therapy helps Veterans with Post Traumatic Stress Disorder (PTSD) and mild traumatic brain injury (mTBI). PTSD is a disorder that occurs after exposure to one or more traumatic experiences. People with PTSD may experience anxiety, pay extra attention to their surroundings, involuntarily remember their traumatic experiences, and/or want to avoid situations where these symptoms are increased. MTBI may result from being in a blast explosion, with pressure from the blast potentially disrupting the brain's structure and function. At this time, it is not well known how PTSD and mTBI may affect each other.

In this study, the investigators will be looking at the behavioral and neurological changes (changes in the brain) and the reductions in PTSD symptoms that may come from participating in this treatment. The investigators are interested in determining if treatment does reverse changes in the brain caused by PTSD and mTBI. To help the investigators understand changes in how the brain functions, the participants will complete a functional magnetic resonance imaging (fMRI) scan before and after either a 8-week course of IRV or 8 weeks of education about PTSD and mTBI. Participation will help the investigators understand how therapy for PTSD and mTBI impacts the brain's response to emotions and therapeutic processes.

Detailed Description

Approximately 18-22% of Operation Enduring Freedom/Operation Iraqi Freedom/ Operation New Dawn (OEF/OIF/OND) Veterans have been diagnosed with posttraumatic stress disorder (PTSD), and 15-30% of Veterans report mild traumatic brain injury (mTBI). The effects of mTBI and PTSD have been evident since military personnel first came home and continue to be difficult to eradicate. At 3-4 months post-deployment, OIF Veterans with mild TBI were more likely to endorse PTSD symptoms than those without mTBI. The co-morbidity may be long-lasting, or at least recurrent, as TBI-related symptoms were strongly associated with traumatic stress five years after injury. In an examination of factors associated with postconcussive symptoms, PTSD was a strong factor. In active duty marines, mTBI during deployment predicted PTSD after deployment, and in a study of OEF-OIF-OND Veterans, 57.3% of those with mTBI had PTSD.

The literature on how mTBI and co-morbid PTSD affect each other and the effects on Veterans several years post-deployment is sparse. Treatment recommendations specific to Veterans with both mTBI and PTSD are in flux, and while treatments address each disorder independently, they may not be effective when the two disorders co-occur. Further impacting successful treatment of Veterans is the fact that many Veterans do not seek treatment, in part due to the distance they travel to obtain VA services and stigma.

Treatments that are accessible and improve symptoms in patients with mTBI and PTSD alone may facilitate rehabilitation in Veterans with co-morbid mTBI and PTSD. Meditation has been suggested to be effective in Veterans with PTSD and in civilians with TBI, improving quality of life. The current study proposes a type of meditation targeted for Veterans, Inner Resources for Veterans (IRV).

Inner Resources for Veterans (IRV) meditation intervention is based on Inner Resources for Stress, an intervention which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment. The Inner Resources protocol targets PTSD and has been associated with reduced PTSD and anxiety symptoms, reduced number of depressive symptoms, and depression remissions at a 9-month follow-up, as well as increased perceived self-efficacy. Pilot results of older combat Veterans with PTSD indicated that Inner Resources is a safe, feasible, and acceptable intervention. In a previous study with IRV in veterans at the Michael E. DeBakey VA, the control condition provided education on the symptoms and effects of PTSD. For example, subjects learned to recognize the circumstances that triggered their symptoms, how to identify and participate in healthy activities, and how to monitor their sleep.

In addition to the changes in functional and psychological symptoms and neural pathways, IRV would offer Veterans a treatment they could utilize whenever challenging situations occur regardless of location. Since the treatment would be relatively cost-free after initial training, IRV could also dramatically reduce financial burden to both Veterans and VA. Few treatment studies focusing on Veterans with co-morbid mTBI and PTSD support the innovation of this study, as does generation of community integration data to relate to changes in functional connectivity.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress Disorders, Post-Traumatic
  • Concussion, Mild
Intervention  ICMJE
  • Behavioral: Inner Resources for Veterans (IRV)
    Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
  • Behavioral: PTSD and mTBI education
    Participants will learn about symptoms and triggers of PTSD and mTBI
Study Arms  ICMJE
  • Experimental: Inner Resources for Veterans meditation therapy
    Participants will complete meditation therapy
    Intervention: Behavioral: Inner Resources for Veterans (IRV)
  • Active Comparator: PTSD and mTBI education
    Participants will learn about symptoms and triggers of PTSD and mTBI
    Intervention: Behavioral: PTSD and mTBI education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
44
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2014)
60
Actual Study Completion Date  ICMJE March 26, 2018
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild traumatic brain injury (mTBI) as defined by the VA/DoD Clinical Practice Guideline.
  • PTSD as assessed by the Clinician Administered PTSD Scale (CAPS);
  • Aged 18 - 49;
  • Have not previously participated in meditation training.

Exclusion Criteria:

The investigators will exclude subjects who:

  • Meet DSM-IV criteria for drug or alcohol abuse in past 30 days;
  • Have a history of severe TBI based on any of following:

    • Glasgow Coma Score < 8;
    • alteration of consciousness greater than 24 hours; loss of consciousness greater than 30 minutes;
  • Have current neurological or general medical conditions known to impact cognitive and/or emotional functioning, including but not limited to:

    • epilepsy,
    • Parkinson's disease,
    • Huntington's disease,
    • Alzheimer's disease,
    • stroke,
    • chemotherapy for cancer;
  • Have acute psychological instability as assessed by MEDVAMC clinician or study staff or concurrent diagnosis or schizophrenia, schizoaffective disorder, delusional disorder, organic psychosis, and subjects taking antipsychotic medication, and
  • Have already completed a course of meditation training.
  • The investigators will also exclude participants with general contraindications for MRI, including metal in or around the head (e.g., orthodontia, non-removable body piercings, etc.), ferromagnetic material in the body (e.g., non-removable body piercings), or non-MRI compatible medical devices.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02280304
Other Study ID Numbers  ICMJE D1608-P
I21RX001608-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Palo Alto University
Investigators  ICMJE
Principal Investigator: Mary R Newsome, PhD Michael E. DeBakey VA Medical Center, Houston, TX
PRS Account VA Office of Research and Development
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP