Text Size
Trial record 3 of 5 for:    MBSR | Open Studies | Exclude Unknown | NCCAM
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified September 2012 by Washington University School of Medicine
Sponsor:
Collaborators:
National Center for Complementary and Alternative Medicine (NCCAM)
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: September 25, 2012
Last verified: September 2012
History of Changes
  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:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

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.


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693874

Contacts
Contact: Leah Wendleton, BA 314-362-5154 wendletl@psychiatry.wustl.edu

Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92122
Contact: Khanh Linhly     858-334-4669        
Principal Investigator: Julie Wetherell            
Sub-Investigator: Steve Hickman            
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Leah Wendleton     314-362-5154        
Principal Investigator: Eric Lenze            
Sub-Investigator: Tammy Hershey            
Sponsors and Collaborators
Washington University School of Medicine
National Center for Complementary and Alternative Medicine (NCCAM)
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: September 25, 2012
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 May 23, 2013