NCT01532596

Brief Summary

The purpose of this study is to test if an 8-week mindfulness meditation training (vs a wait-list control condition) program reduces neurobehavioral reactivity and improves affect regulation in a sample of older adults, as measured by functional magnetic resonance imaging. Additionally, we will examine if mindfulness meditation training reduces loneliness and markers of chronic inflammation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2008

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2012

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

February 8, 2012

Last Update Submit

February 9, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional Neural Activity

    Neural responses to emotionally evocative stimuli

    Change from Baseline to 2 months

Secondary Outcomes (3)

  • Pro-inflammation

    Change from Baseline to 2 months

  • Loneliness

    Change from Baseline to 2 months

  • Psychological Distress

    Change from Baseline to 2 months

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

A standardized 8-week mindfulness meditation training program

Behavioral: Mindfulness-Based Stress Reduction

Wait-List

NO INTERVENTION

Interventions

8-week standardized mindfulness meditation training program

Also known as: MBSR
Mindfulness-Based Stress Reduction

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking adults between the ages of 55-85 years of age at time of entry
  • post-menopausal and not pregnant (women only)
  • Accessible geographically and willing to come to UCLA for all study related activities

You may not qualify if:

  • they have regularly (\>1 time per week) practiced a mind-body therapy anytime in the last six months (e.g., meditation, yoga, tai chi)
  • are not ambulatory, (c) indicate any treatment for mental health problems in the last six months
  • indicate any major physical health problems in the last three months
  • use medications affecting cardiovascular or endocrine function
  • are left-handed
  • or have metal in their bodies (including pacemakers and permanent piercings (e.g., bellyrings), but not dental fillings)
  • indicate regular use of psychotropic medication or psychotherapy in the last six months
  • cognitive impairment as indicated by a score lower than 23 on the Mini-Mental State examination
  • smokers
  • indicate feeling claustrophobic in confined spaces, such as an fMRI scanner
  • weigh over 300 lbs
  • indicate any use of doctor prescribed cholesterol lowering medications (e.g., statins)
  • use any doctor prescribed pain medication
  • indicate any implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cousins Center for Psychoneuroimmunology, UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • J. David Creswell, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Doctoral Fellow, Cousins Center for Psychoneuroimmunology

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 14, 2012

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations