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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01693874
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH), University of California, San Diego (Other)
• Enrollment: 103
• Locations: 2
• Arms: 2
• Duration (Months): 32
• Patients Per Site: 51.5
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders; Depression	Behavioral: MBSR; Behavioral: control (health education)	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. cognitive functioning [approximately 2 months of study intervention]

   neuropsychological battery examining memory, executive functioning, and attention

Secondary Outcome Measures

1. mind-wandering [2 months of intervention]

   computerized task(s) of mind-wandering

2. mindfulness [2 months of intervention]

   self-report plus ecological momentary assessment measurements of mindfulness (process variable).

3. anxiety and depressive symptoms [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego	San Diego	California	United States	92122
2	Washington University School of Medicine	St Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• National Center for Complementary and Integrative Health (NCCIH)
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric Lenze, Professor of Psychiatry, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01693874
• Other Study ID Numbers: AT007064
• First Posted: Sep 26, 2012
• Last Update Posted: Jul 23, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Eric Lenze, Professor of Psychiatry, Washington University School of Medicine: anxiety; depression; cognition; MBSR; mindfulness; stress; elderly
• Additional relevant MeSH terms: Depression; Anxiety Disorders

Study Results

No Results Posted as of Jul 23, 2014