Recruiting

Brain Health

Sponsor:

East Bay Institute for Research and Education

Code:

NCT06150196

Conditions

Brain Injury Traumatic Mild

Post-traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mindfulness-based Stress Reduction class

Brain Health Education class

Study Details

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

Study ID

NCT06150196

Start date

May 1, 2023

Status verified date

Nov, 2023

Completion date

Sep 14, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Mindfulness-based Stress Reduction class

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

Brain Health Education class

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

Primary outcome measure

  • Mayo-Portland Adaptability Inventory [ Time Frame: Within 2 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Juliana Baldo, PhD

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

Locations

VA Northern California Health Care System

Recruiting

Martinez, California, United States, 94553

Contacts

Juliana Baldo, PhD

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

Sandy Lwi, PhD

925-372-2925Sandy.Lwi@va.gov

More Information

Sponsor

East Bay Institute for Research and Education

Last update posted

Nov 29, 2023

Last verified

Nov, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by East Bay Institute for Research and Education on 2023-11-29.