Mindfulness Training in Healthy Older Veterans (MTGHOV)

Improving Brain Health in Older Veterans: A Mindfulness Training Pilot Study

Evidence shows the positive effects of Brain Health & Wellness classes in younger individuals. The proposed study investigates the usefulness of these classes in older Veterans aged 50-85. We hope to show that such classes can lead to improvements in both thinking skills as well as stress levels.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: Mindfulness-based Stress Reduction; Behavioral: Brain Health

Detailed Description

The expansion of the aging Veteran population, in addition to the frequent presence of comorbidities (e.g., PTSD and TBI) that exacerbate age-associated cognitive and health declines, has generated substantial interest in interventions that promote brain health in older Veterans. A growing body of evidence shows the positive effects of Brain Health & Wellness classes on brain health in younger and middle-aged adults, thus training might be able to enhance brain health in older Veterans and offset age-related declines. Such training holds particular promise in enhancing areas of cognition that are especially susceptible to aging processes (e.g. attention and executive control), potentially through multiple mechanistic pathways. It is in many respects a cognitive exercise and may strengthen neural networks involved in such processes. Additionally, there is evidence for further facilitating brain health in other ways related to, for instance, altering the stress response. Currently, there is little information regarding the potential brain health benefits in older adults. As a first step to understanding these potential beneficial effects in Veterans, the aim of the proposed pilot study is to evaluate the acceptability, feasibility and potential efficacy of two Brain Health & Wellness classes in healthy older Veterans through a randomized, controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95655
      • VA Northern California Health Care System, Mather, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will be Veterans age 50-85

Exclusion Criteria:

• moderate or severe TBI
• active alcohol or drug dependence or abuse by DSM-5 criteria (within previous 30 days)
• positive urine drug screen for illicit substances
• history of schizophrenia
• ADHD
• learning disability
• dementia
• Mild Cognitive Impairment and/or other psychiatric disturbances not including PTSD and/or depression
• participants with a history of psychiatric hospitalization (last five years)
• suicide attempt (last five years)
• imminent risk for suicidal or homicidal behavior, or severe medical illness requiring treatment will be excluded

• subjects with a history of neurological diagnosis, e.g.,:

  • brain tumor
  • clinical stroke
  • seizure
• Mini-Mental Status Exam score below 19 (suggesting moderate/severe cognitive impairment, a contraindication to MBSR participation) will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; mindfulness/meditation/movement training	Behavioral: Mindfulness-based Stress Reduction; mindfulness/meditation/movement training; Other Names: MBSR
Active Comparator: Brain Health; Brain Health education class	Behavioral: Brain Health; Brain Health Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geriatric Depression Scale Change Score	Participants' scores on the Geriatric Depression Scale were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. This outcome measure represents the change in score in Geriatric Depression Scale: pre-intervention score minus post-intervention score. The maximum Geriatric Depression Scale score is 30, and the minimum score is 0. Higher scores on the Geriatric Depression Scale indicate more depressive symptoms, so worse outcome. However, since we are analyzing a change in the Geriatric Depression Scale score of pre- minus post-intervention, a larger change score for a particular arm indicates a greater degree of improvement.	Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)
State-Trait Anxiety Inventory (STAI) Change Score	Participants' scores on the State-Trait Anxiety Inventory (STAI) were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. This outcome measure represents the change in score in State-Trait Anxiety Inventory: pre-intervention score minus post-intervention score. The maximum STAI score is 80, and the minimum score is 20. Higher scores on the STAI indicate more anxiety symptoms, so worse outcome. However, since we are analyzing a change in the STAI score of pre- minus post-intervention, a larger change score for a particular arm indicates a greater degree of improvement.	Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatable Battery for Neuropsychological Status (RBANS) Total Scaled Change Score	Participants' scores on the Repeatable Battery for Neuropsychological Status (RBANS) were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. The maximum total scaled score is 160, and the minimum score is 40, where higher scores are better. This outcome measure represents the change in total scaled score on the RBANS: post-intervention score minus pre-intervention score. A higher change score for a particular arm indicates a greater degree of improvement.	Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Veterans; mindfulness; aging
• Other Study ID Numbers: E2398-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No