Clinical trial NCT02816723: Mindfulness Training in Healthy Older Veterans
Official title: Improving Brain Health in Older Veterans: A Mindfulness Training Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: mindfulness
aging
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Geriatric Depression Scale Change Score
timeFrame: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)
measure: State-Trait Anxiety Inventory (STAI) Change Score
timeFrame: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)
Secondary outcomes:
measure: Repeatable Battery for Neuropsychological Status (RBANS) Total Scaled Change Score
timeFrame: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
Study officials:
affiliation: VA Northern California Health Care System, Mather, CA
name: Juliana V. Baldo, PhD
role: PRINCIPAL_INVESTIGATOR
References: