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Meditation in Veterans With PTSD and Mild TBI

Primary Purpose

Stress Disorders, Post-Traumatic, Concussion, Mild

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inner Resources for Veterans (IRV)
Essential Skills therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Stress Disorders, Post-Traumatic, Concussion, Mild, Brain Injuries, Community Integration, Meditation, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inner Resources for Veterans (IRV) mindfulness and mantra

Essential Skills therapy

Arm Description

Complete a mindfulness and mantra therapy

Learn symptoms of mTBI and PTSD, coping skills

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale (CAPS5)
Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control.

Secondary Outcome Measures

Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control
Functional connectivity was measured between the Default Mode Network (DMN) and lateral prefrontal cortex (LPFC), and between the amygdala and anterior cingulate. There were four seeds for the DMN (MPFC, PCC, left lateral parietal, right lateral parietal), and two seeds for the amygdala (right and left). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p<.001 at the voxel level and p<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.
Community Reintegration in Service Members (CRIS)
Scores at baseline and 12 weeks in responses to the computerized version of the Community Reintegration in Service Members (CRIS-CAT) questionnaire in patients following meditation or control. There are three subscales: Extent of Participation (range 24-90), Perceived Limitations (range 33-99), and Satisfaction (range 34-91). Higher is better.

Full Information

First Posted
October 17, 2014
Last Updated
February 24, 2020
Sponsor
VA Office of Research and Development
Collaborators
Palo Alto University
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1. Study Identification

Unique Protocol Identification Number
NCT02280304
Brief Title
Meditation in Veterans With PTSD and Mild TBI
Official Title
Neuroimaging Meditation Therapy in Veterans With Co-Morbid TBI and PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 3, 2014 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Palo Alto University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to learn more about how Inner Resources for Veterans (IRV), a mindfulness and mantra 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 emotionally 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 IRV or an active control group. Both conditions are 9-session, 12-week interventions. 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. Mindfulness and mantra have 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 mindfulness targeted for Veterans, Inner Resources for Veterans (IRV). Inner Resources for Veterans (IRV), a mindfulness and mantra intervention, is based on Inner Resources for Stress, an intervention which utilizes mindfulness, techniques that encourage present moment attention for the purpose of promoting better self-monitoring and self-regulation, and mantra, the repetition of sounds that do not have meaning in order to maintain present focused attention. 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. The control condition is an active treatment called Essential Skills, a manualized therapy adapted from a similar therapy utilized at multiple VAs as a psychoeducational and symptom management treatment for PTSD. In a previous study at the Michael E. DeBakey VA that did not investigate the effect of mTBI, Essential Skills 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 the current study, in Essential Skills, Veterans learn about symptoms of both mTBI and PTSD and coping skills. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Concussion, Mild
Keywords
Stress Disorders, Post-Traumatic, Concussion, Mild, Brain Injuries, Community Integration, Meditation, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inner Resources for Veterans (IRV) mindfulness and mantra
Arm Type
Experimental
Arm Description
Complete a mindfulness and mantra therapy
Arm Title
Essential Skills therapy
Arm Type
Active Comparator
Arm Description
Learn symptoms of mTBI and PTSD, coping skills
Intervention Type
Behavioral
Intervention Name(s)
Inner Resources for Veterans (IRV)
Intervention Description
Mindfulness and breath-focused mantra therapy which uses techniques that encourage present moment attention for the purpose of improving self-monitoring and self-regulation
Intervention Type
Behavioral
Intervention Name(s)
Essential Skills therapy
Intervention Description
This active comparator is adapted from a therapy utilized at multiple VAs as a psychoeducational AND symptom management treatment for PTSD. In it, participants learn about mTBI and PTSD symptoms and coping information for PTSD.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS5)
Description
Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control
Description
Functional connectivity was measured between the Default Mode Network (DMN) and lateral prefrontal cortex (LPFC), and between the amygdala and anterior cingulate. There were four seeds for the DMN (MPFC, PCC, left lateral parietal, right lateral parietal), and two seeds for the amygdala (right and left). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p<.001 at the voxel level and p<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.
Time Frame
12 weeks and baseline
Title
Community Reintegration in Service Members (CRIS)
Description
Scores at baseline and 12 weeks in responses to the computerized version of the Community Reintegration in Service Members (CRIS-CAT) questionnaire in patients following meditation or control. There are three subscales: Extent of Participation (range 24-90), Perceived Limitations (range 33-99), and Satisfaction (range 34-91). Higher is better.
Time Frame
12 weeks and baseline
Other Pre-specified Outcome Measures:
Title
PTSD Checklist 5 (PCL5) Difference Score
Description
The PTSD Checklist 5 (PCL5) is a measure of PTSD symptoms based on DSM-V. The scores fall in the range 0-80; higher scores indicate worse outcome. We calculated the PTSD Checklist 5 (PCL5) difference score by subtracting the value at baseline minus the value at week 12. In this case higher scores represent a reduction in PTSD symptoms.
Time Frame
12 weeks, baseline
Title
Patient Health Questionnaire-9 (PHQ-9) Patient Depression Questionnaire Difference Score
Description
The Patient Health Questionnaire-9 (PHQ-9) measure is a self-report measure of depression symptoms. Scores fall in the range 0-27; higher scores indicate worse outcome. This difference score denotes improvement in symptoms of depression. It was calculated by subtracting the value of PHQ-9 scores at baseline minus PHQ-9 scores scores at week 12.
Time Frame
12 weeks, baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary R Newsome, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Meditation in Veterans With PTSD and Mild TBI

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