Mindfulness Training in Healthy Older Veterans

Aging Clinical Trial

— MTGHOV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816723
• Other study ID #: E2398-P
• Status: Completed
• Phase: N/A
• Start date: November 28, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Mindfulness-based Stress Reduction
mindfulness/meditation/movement training
• Brain Health
Brain Health Education

Locations

Country	Name	City	State
United States	VA Northern California Health Care System, Mather, CA	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)