- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693874
Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
July 21, 2014 updated by: Eric Lenze, Washington University School of Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92122
- University of California San Diego
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness Based Stress Reduction
All participants in this arm receive Mindfulness Based Stress Reduction (MBSR).
|
Mindfulness-Based Stress Reduction
|
Active Comparator: control
All participants in this arm receive an attention control
|
health education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cognitive functioning
Time Frame: approximately 2 months of study intervention
|
neuropsychological battery examining memory, executive functioning, and attention
|
approximately 2 months of study intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mind-wandering
Time Frame: 2 months of intervention
|
computerized task(s) of mind-wandering
|
2 months of intervention
|
mindfulness
Time Frame: 2 months of intervention
|
self-report plus ecological momentary assessment measurements of mindfulness (process variable).
|
2 months of intervention
|
anxiety and depressive symptoms
Time Frame: 2 months of intervention
|
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.
|
2 months of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Julie Wetherell, PhD, University of California, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
March 29, 2012
First Submitted That Met QC Criteria
September 25, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Estimate)
July 23, 2014
Last Update Submitted That Met QC Criteria
July 21, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AT007064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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