Meditation in Veterans With PTSD and Mild TBI

NCT02280304 | Completed Results

• 2 other identifiers: D1608-PI21RX001608-01A1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Concussion, Mild

Keywords

Stress Disorders, Post-Traumatic; Concussion, Mild; Brain Injuries; Community Integration; Meditation; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale (CAPS5)

  Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control.

  12 weeks

Secondary Outcomes (2)

• Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control

  12 weeks and baseline

• Community Reintegration in Service Members (CRIS)

  12 weeks and baseline

Other Outcomes (2)

• PTSD Checklist 5 (PCL5) Difference Score

  12 weeks, baseline

• Patient Health Questionnaire-9 (PHQ-9) Patient Depression Questionnaire Difference Score

  12 weeks, baseline

Study Arms (2)

Inner Resources for Veterans (IRV) mindfulness and mantra

EXPERIMENTAL

Complete a mindfulness and mantra therapy

Behavioral: Inner Resources for Veterans (IRV)

Essential Skills therapy

ACTIVE COMPARATOR

Learn symptoms of mTBI and PTSD, coping skills

Behavioral: Essential Skills therapy

Interventions

Inner Resources for Veterans (IRV) BEHAVIORAL

Mindfulness and breath-focused mantra therapy which uses techniques that encourage present moment attention for the purpose of improving self-monitoring and self-regulation

Inner Resources for Veterans (IRV) mindfulness and mantra

Essential Skills therapy BEHAVIORAL

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.

Essential Skills therapy

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Palo Alto University: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Concussion; Brain Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Dr. Mary Newsome
• Organization: Michael E. DeBakey VA Medical Center

mary.newsome@va.gov

713-791-1414

Study Officials

• Mary R Newsome, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 31, 2014
• Study Start: November 3, 2014
• Primary Completion: June 30, 2017
• Study Completion: March 26, 2018
• Last Updated: March 9, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)