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Mindfulness-Based Stress Reduction for Hot Flashes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01052454
First Posted: January 20, 2010
Last Update Posted: January 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Massachusetts, Worcester
  Purpose
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

Condition Intervention Phase
Vasomotor Symptoms Behavioral: Mindfulness-based stress reduction Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study to Assess the Feasibility of MBSR for Hot Flashes

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Hot Flash intensity/bother

Enrollment: 110
Study Start Date: September 2005
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Mindfulness-based stress reduction
Participants in the MBSR arm attend eight weekly classes.
Other Name: MBSR

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women experiencing 5 or more hot flashes/day
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052454


Locations
United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
  More Information

Responsible Party: James Carmody, University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT01052454     History of Changes
Other Study ID Numbers: AT002910
First Submitted: January 18, 2010
First Posted: January 20, 2010
Last Update Posted: January 20, 2010
Last Verified: January 2010

Keywords provided by University of Massachusetts, Worcester:
hot flashes
mindfulness
stress

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms