Brain Injury Traumatic Mild, Post-traumatic Stress Disorder
Conditions
Keywords
Mindfulness, Mindfulness-based Stress Reduction, TBI, Anxiety, PTSD, Veteran
Brief summary
This study is testing the usefulness of two types of Brain Health & Wellness classes for Veterans with a history of concussion to improve mental health.
Detailed description
This is a pragmatic, randomized controlled trial of Mindfulness-based Stress Reduction (MBSR) in 120 Veterans with comorbid PTSD and chronic mTBI. Half of the participants are randomly assigned to MBSR and the other half, to a Brain Health education class, which serves as an active control group. A battery of standardized psychological and cognitive measures are administered prior to and following the class interventions to assess change in response to the intervention, with an additional 6-month follow-up assessment to test for lasting changes. The primary outcome measures include the Mayo-Portland Adaptability Inventory IV (functional outcome), PTSD Checklist (psychological outcome), and cognitive control test (cognitive outcome).
Interventions
BEHAVIORALMindfulness-based Stress Reduction class
9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga
BEHAVIORALBrain Health Education class
9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury
Sponsors
East Bay Institute for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years old * chronic history (\>6 months) of one or more mTBIs * current diagnosis of PTSD * at least one self-reported cognitive symptom
Exclusion criteria
* no history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson's) * no history of major brain surgery * no history of moderate or severe TBI * no active alcohol or drug dependence or abuse within previous 30 days * no history of severe psychotic disorder (e.g., schizophrenia) * no current suicidal ideation/risk * no clinically severe medical illness requiring treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mayo-Portland Adaptability Inventory | Within 2 weeks post-intervention | Measure of Instrumental Activities of Daily Living with overall score of 0-111, with higher scores indicate greater impairment |
Countries
United States
Outcome results
None listed