Mindfulness Training in Healthy Older Veterans

NCT ID: NCT02816723

Last Updated: 2020-04-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-28

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness

mindfulness/meditation/movement training

Group Type EXPERIMENTAL

Mindfulness-based Stress Reduction

Intervention Type BEHAVIORAL

mindfulness/meditation/movement training

Brain Health

Brain Health education class

Group Type ACTIVE_COMPARATOR

Brain Health

Intervention Type BEHAVIORAL

Brain Health Education

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness-based Stress Reduction

mindfulness/meditation/movement training

Intervention Type BEHAVIORAL

Brain Health

Brain Health Education

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MBSR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juliana V. Baldo, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Northern California Health Care System, Mather, CA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E2398-P

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Active Mind Study
NCT03289546 COMPLETED NA