Mindfulness Training in Healthy Older Veterans

Not Applicable

Completed

• Conditions: Aging
• Interventions: Behavioral: Mindfulness-based Stress Reduction; Behavioral: Brain Health

• Registration Number: NCT02816723
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Study Start: 2016-11-28
• Primary Completion: 2019-05-30
• Study Completion: 2019-07-31
• Status Verified: 2020-03
• Results First Submitted: 2020-03-09
• Results First Submitted QC: 2020-03-24
• Last Update Submitted: 2020-03-24
• Results First Posted: 2020-04-07
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subjects will be Veterans age 50-85

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Mindfulness-based Stress Reduction	mindfulness/meditation/movement training
Brain Health	Brain Health	Brain Health education class

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI) Change Score	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.
Geriatric Depression Scale Change Score	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.

Secondary Outcome Measures

Name	Time	Method
Repeatable Battery for Neuropsychological Status (RBANS) Total Scaled Change Score	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.

Trial Locations

Locations (1)

VA Northern California Health Care System, Mather, CA; 🇺🇸 Sacramento, California, United States