Back to resultsMindfulness-Based Stress Reduction for Hot Flashes
Primary Purpose
Vasomotor Symptoms
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based stress reduction
Sponsored by
About this trial
This is an interventional treatment trial for Vasomotor Symptoms focused on measuring hot flashes, mindfulness, stress
Eligibility Criteria
Inclusion Criteria:
- Women experiencing 5 or more hot flashes/day
Sites / Locations
- UMass Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Wait list
Mindfulness-based stress reduction
Arm Description
Women assigned to the waitlist have the opportunity of taking the MBSR program at no cost following final study assessment
Women in the MBSR arm attend eight weekly MBSR classes
Outcomes
Primary Outcome Measures
Hot Flash intensity/bother
Secondary Outcome Measures
Full Information
NCT ID
NCT01052454
First Posted
January 18, 2010
Last Updated
January 19, 2010
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT01052454
Brief Title
Mindfulness-Based Stress Reduction for Hot Flashes
Official Title
Pilot Study to Assess the Feasibility of MBSR for Hot Flashes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to determine if participation in a mindfulness-based stress reduction program is feasible for women experiencing five or more hot flashes/day, and whether it affects either the frequency and/or intensity of their hot flashes, or the degree of bother they experience from them
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Symptoms
Keywords
hot flashes, mindfulness, stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Women assigned to the waitlist have the opportunity of taking the MBSR program at no cost following final study assessment
Arm Title
Mindfulness-based stress reduction
Arm Type
Experimental
Arm Description
Women in the MBSR arm attend eight weekly MBSR classes
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction
Other Intervention Name(s)
MBSR
Intervention Description
Participants in the MBSR arm attend eight weekly classes.
Primary Outcome Measure Information:
Title
Hot Flash intensity/bother
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women experiencing 5 or more hot flashes/day
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
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Mindfulness-Based Stress Reduction for Hot Flashes
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