Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

NCT06150196 | Recruiting

• 1 other identifier: W81XWH-22-1-0820
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury Traumatic Mild; Post-traumatic Stress Disorder

Keywords

Mindfulness; Mindfulness-based Stress Reduction; TBI; Anxiety; PTSD; Veteran

Outcome Measures

Primary Outcomes (1)

• Mayo-Portland Adaptability Inventory

  Measure of Instrumental Activities of Daily Living with overall score of 0-111, with higher scores indicate greater impairment

  Within 2 weeks post-intervention

Study Arms (2)

Mindfulness-based Stress Reduction class

EXPERIMENTAL

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.

Behavioral: Mindfulness-based Stress Reduction class

Brain Health Education Class

ACTIVE COMPARATOR

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.

Behavioral: Brain Health Education class

Interventions

Mindfulness-based Stress Reduction class BEHAVIORAL

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

Mindfulness-based Stress Reduction class

Brain Health Education class BEHAVIORAL

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

Brain Health Education Class

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• chronic history (\>6 months) of one or more mTBIs
• current diagnosis of PTSD
• at least one self-reported cognitive symptom

You may not qualify if:

• 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

Sponsors & Collaborators

• East Bay Institute for Research and Education: lead

Study Sites (1)

VA Northern California Health Care System

Martinez, California, 94553, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Juliana Baldo, PhD

CONTACT

925-372-4649; Juliana.Baldo@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 29, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 14, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)