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
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women experiencing 5 or more hot flashes/day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052454

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

No publications provided

Responsible Party: James Carmody, University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT01052454     History of Changes
Other Study ID Numbers: AT002910
Study First Received: January 18, 2010
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014