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Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

NCT ID: NCT06150196

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-09-14

Brief Summary

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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

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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).

Conditions

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Brain Injury Traumatic Mild Post-traumatic Stress Disorder

Keywords

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Mindfulness Mindfulness-based Stress Reduction TBI Anxiety PTSD Veteran

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness-based Stress Reduction class

Mindfulness-based Stress Reduction (MBSR) is a 9-week class that meets 2.5 hours/week and involves training in mindfulness (being present in the moment), meditation, and yoga. The MBSR course is taught by a certified MBSR instructor.

Group Type EXPERIMENTAL

Mindfulness-based Stress Reduction class

Intervention Type BEHAVIORAL

9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga

Brain Health Education Class

the Brain Health Education Class is a 9-week class that meets 2.5 hours/week and involves lectures/discussion about how the brain works, how the brain ages, neuroplasticity, and other topics on the brain.

Group Type ACTIVE_COMPARATOR

Brain Health Education class

Intervention Type BEHAVIORAL

9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury

Interventions

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Mindfulness-based Stress Reduction class

9-week standard Mindfulness-based Stress Reduction class training on mindfulness techniques, medication, and yoga

Intervention Type BEHAVIORAL

Brain Health Education class

9-week Brain Health education class that involves lectures/discussion about how the brain works and recovers after brain injury

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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East Bay Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VA Northern California Health Care System

Martinez, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Juliana Baldo, PhD

Role: CONTACT

Phone: 925-372-4649

Email: [email protected]

Facility Contacts

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Juliana Baldo, PhD

Role: primary

Sandy Lwi, PhD

Role: backup

Other Identifiers

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W81XWH-22-1-0820

Identifier Type: -

Identifier Source: org_study_id