Mindfulness-Based Stress Reduction for Hot Flashes
Sponsor
University of Massachusetts, Worcester (Other)
Overall Status
Completed
CT.gov ID
NCT01052454
Collaborator
(none)
110
1
2
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
110 participants
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
Study Start Date
:
Sep 1, 2005
Actual Primary Completion Date
:
May 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Hot Flash intensity/bother []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Women experiencing 5 or more hot flashes/day
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UMass Medical School | Worcester | Massachusetts | United States | 01655 |
Sponsors and Collaborators
- University of Massachusetts, Worcester
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01052454
Other Study ID Numbers:
- AT002910
First Posted:
Jan 20, 2010
Last Update Posted:
Jan 20, 2010
Last Verified:
Jan 1, 2010