Mindfulness-Based Stress Reduction for Hot Flashes

This study has been completed.

Sponsor:

Information provided by:

University of Massachusetts, Worcester

ClinicalTrials.gov Identifier:

NCT01052454

First received: January 18, 2010

Last updated: January 19, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 18, 2010
Last Updated Date	January 19, 2010
Start Date ^ICMJE	September 2005
Primary Completion Date	May 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2010)	Hot Flash intensity/bother
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01052454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Mindfulness-Based Stress Reduction for Hot Flashes
Official Title ^ICMJE	Pilot Study to Assess the Feasibility of MBSR for Hot Flashes
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
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 0
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Vasomotor Symptoms
Intervention ^ICMJE	Behavioral: Mindfulness-based stress reduction Participants in the MBSR arm attend eight weekly classes. Other Name: MBSR
Study Arm (s)	No Intervention: Wait list Women assigned to the waitlist have the opportunity of taking the MBSR program at no cost following final study assessment Experimental: Mindfulness-based stress reduction Women in the MBSR arm attend eight weekly MBSR classes Intervention: Behavioral: Mindfulness-based stress reduction
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	110
Completion Date
Primary Completion Date	May 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women experiencing 5 or more hot flashes/day
Gender	Female
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01052454
Other Study ID Numbers ^ICMJE	AT002910
Has Data Monitoring Committee	No
Responsible Party	James Carmody, University of Massachusetts Medical School
Study Sponsor ^ICMJE	University of Massachusetts, Worcester
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	University of Massachusetts, Worcester
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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