Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
Primary Purpose
Anxiety Disorders, Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MBSR
control (health education)
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring anxiety, depression, cognition, MBSR, mindfulness, stress, elderly
Eligibility 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
Sites / Locations
- University of California San Diego
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Based Stress Reduction
control
Arm Description
All participants in this arm receive Mindfulness Based Stress Reduction (MBSR).
All participants in this arm receive an attention control
Outcomes
Primary Outcome Measures
cognitive functioning
neuropsychological battery examining memory, executive functioning, and attention
Secondary Outcome Measures
mind-wandering
computerized task(s) of mind-wandering
mindfulness
self-report plus ecological momentary assessment measurements of mindfulness (process variable).
anxiety and depressive symptoms
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.
Full Information
NCT ID
NCT01693874
First Posted
March 29, 2012
Last Updated
July 21, 2014
Sponsor
Washington University School of Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01693874
Brief Title
Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
Official Title
Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression
Keywords
anxiety, depression, cognition, MBSR, mindfulness, stress, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Stress Reduction
Arm Type
Experimental
Arm Description
All participants in this arm receive Mindfulness Based Stress Reduction (MBSR).
Arm Title
control
Arm Type
Active Comparator
Arm Description
All participants in this arm receive an attention control
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Intervention Description
Mindfulness-Based Stress Reduction
Intervention Type
Behavioral
Intervention Name(s)
control (health education)
Intervention Description
health education
Primary Outcome Measure Information:
Title
cognitive functioning
Description
neuropsychological battery examining memory, executive functioning, and attention
Time Frame
approximately 2 months of study intervention
Secondary Outcome Measure Information:
Title
mind-wandering
Description
computerized task(s) of mind-wandering
Time Frame
2 months of intervention
Title
mindfulness
Description
self-report plus ecological momentary assessment measurements of mindfulness (process variable).
Time Frame
2 months of intervention
Title
anxiety and depressive symptoms
Description
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.
Time Frame
2 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Lenze, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie Wetherell, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Washington University School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35476747
Citation
Kornfield SL, Nicol GE, Lenze EJ, Yingling M, Loebach Wetherell J. Mindfulness-Based Stress Reduction in Older Individuals: Who Benefits the Most? Adv Mind Body Med. 2022 Winter;36(1):4-12.
Results Reference
derived
PubMed Identifier
32017250
Citation
Haddad R, Lenze EJ, Nicol G, Miller JP, Yingling M, Wetherell JL. Does patient expectancy account for the cognitive and clinical benefits of mindfulness training in older adults? Int J Geriatr Psychiatry. 2020 Jun;35(6):626-632. doi: 10.1002/gps.5279. Epub 2020 Mar 20.
Results Reference
derived
PubMed Identifier
28686822
Citation
Wetherell JL, Hershey T, Hickman S, Tate SR, Dixon D, Bower ES, Lenze EJ. Mindfulness-Based Stress Reduction for Older Adults With Stress Disorders and Neurocognitive Difficulties: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e734-e743. doi: 10.4088/JCP.16m10947.
Results Reference
derived
Learn more about this trial
Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
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