Skip to main content
OpenTrials
Completed

NCT Number: NCT02816723

Mindfulness Training in Healthy Older Veterans

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

mindfulness/meditation/movement training

Other names: MBSR

Brain Health

Behavioral

Brain Health Education

Primary outcomes

  1. Geriatric Depression Scale Change Score

    Time frame: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)

    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.

  2. State-Trait Anxiety Inventory (STAI) Change Score

    Time frame: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)

    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.

Secondary outcomes

  1. Repeatable Battery for Neuropsychological Status (RBANS) Total Scaled Change Score

    Time frame: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: MTGHOV

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2016
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.