AgingMTGHOVNCT02816723
Mindfulness Training in Healthy Older Veterans
A study testing Mindfulness-based Stress Reduction and Brain Health in people with Aging, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Mindfulness-based Stress Reduction and Brain Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2016to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be Veterans age 50-85
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655
About this study
Official title: Improving Brain Health in Older Veterans: A Mindfulness Training Pilot Study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Mindfulness-based Stress Reduction, Brain Health
- Keywords
- mindfulness, aging, Veterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress ReductionBehavioural
Also called MBSR
mindfulness/meditation/movement training
Brain HealthBehavioural
Brain Health Education
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | mindfulness/meditation/movement training Receives: Behavioral: Mindfulness-based Stress Reduction |
| Brain Health | Active comparator | Brain Health education class Receives: Behavioral: Brain Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start28 Nov 2016
- Primary completion30 May 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Juliana V. Baldo, PhD, Principal investigator, VA Northern California Health Care System, Mather, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816723
- Sponsor's protocol ID
- E2398-P
- Acronym
- MTGHOV
- Status last verified
- Mar 2020
- First submitted
- 24 Jun 2016
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Brain Health in Older Veterans: A Mindfulness Training Pilot Study
- ClinicalTrials.gov ID
- NCT02816723
- Acronym / sponsor ID
- MTGHOV / E2398-P
- Conditions
- Aging
- Keywords
- mindfulness, aging, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness-based Stress Reductionmindfulness/meditation/movement training |
| Brain Health | Active comparator | Behavioral: Brain HealthBrain Health education class |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will be Veterans age 50-85
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Stress ReductionAlso: MBSRmindfulness/meditation/movement training | Behavioural | Mindfulness |
| Brain HealthBrain Health Education | Behavioural | Brain Health |
Primary outcome
Geriatric Depression Scale Change Score
Time frame: 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.
State-Trait Anxiety Inventory (STAI) Change Score
Time frame: 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.
1 secondary outcome
Repeatable Battery for Neuropsychological Status (RBANS) Total Scaled Change Score
Time frame: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana V. Baldo, PhD principal investigator
VA Northern California Health Care System, Mather, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Stress Reduction and Brain Health in people with Aging, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Depression Scale Change Score (time frame: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.