Mindfulness Training in Healthy Older Veterans

NCT02816723 | Completed Results

• 1 other identifier: E2398-P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

mindfulness; aging; Veterans

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Mindfulness

EXPERIMENTAL

mindfulness/meditation/movement training

Behavioral: Mindfulness-based Stress Reduction

Brain Health

ACTIVE COMPARATOR

Brain Health education class

Behavioral: Brain Health

Interventions

Mindfulness-based Stress Reduction BEHAVIORAL

mindfulness/meditation/movement training

Also known as: MBSR

Mindfulness

Brain Health BEHAVIORAL

Brain Health Education

Brain Health

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be Veterans age 50-85

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Juliana Baldo
• Organization: VA Northern California Health Care System

Juliana.Baldo@VA.gov

925-372-4649

Study Officials

• Juliana V. Baldo, PhD

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: November 28, 2016
• Primary Completion: May 30, 2019
• Study Completion: July 31, 2019
• Last Updated: April 7, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)