Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging

This study has been completed.
Sponsor:
Collaborators:
University of California, San Diego
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01693874
First received: March 29, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

The investigators are developing and then testing whether Mindfulness-Based Stress Reduction, a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms and improves cognitive functioning in older adults.


Condition Intervention Phase
Anxiety Disorders
Depression
Behavioral: MBSR
Behavioral: control (health education)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • cognitive functioning [ Time Frame: approximately 2 months of study intervention ] [ Designated as safety issue: No ]
    neuropsychological battery examining memory, executive functioning, and attention


Secondary Outcome Measures:
  • mind-wandering [ Time Frame: 2 months of intervention ] [ Designated as safety issue: No ]
    computerized task(s) of mind-wandering

  • mindfulness [ Time Frame: 2 months of intervention ] [ Designated as safety issue: No ]
    self-report plus ecological momentary assessment measurements of mindfulness (process variable).

  • anxiety and depressive symptoms [ Time Frame: 2 months of intervention ] [ Designated as safety issue: No ]
    scales of self-report anxiety and depressive symptoms from NIH PROMIS, and worry severity (Penn State Worry Questionnaire Abbreviated). also we will examine ecological momentary assessment measurements of anxiety and depressive symptoms.


Enrollment: 103
Study Start Date: October 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Based Stress Reduction
All participants in this arm receive Mindfulness Based Stress Reduction (MBSR).
Behavioral: MBSR
Mindfulness-Based Stress Reduction
Active Comparator: control
All participants in this arm receive an attention control
Behavioral: control (health education)
health education

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 65+
  • current depressive and/or anxiety symptoms
  • current depressive and/or anxiety disorder
  • able to participate in behavioral study

Exclusion Criteria:

  • unable to participate in study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693874

Locations
United States, California
University of California San Diego
San Diego, California, United States, 92122
United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
University of California, San Diego
Investigators
Principal Investigator: Eric Lenze, MD Washington University School of Medicine
Principal Investigator: Julie Wetherell, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: Eric Lenze, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01693874     History of Changes
Other Study ID Numbers: AT007064
Study First Received: March 29, 2012
Last Updated: July 21, 2014
Health Authority: Data and Safety monitoring board: Helen Lavretsky, M.D., UCLA, and Dimitris Kiossis, Ph.D., Cornell University

Keywords provided by Washington University School of Medicine:
anxiety
depression
cognition
MBSR
mindfulness
stress
elderly

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 26, 2014