Mindfulness Based Stress Reduction for Hot Flashes
1 other identifier
interventional
110
1 country
1
Brief Summary
Stress appears to be related to hot flash frequency and intensity, and the degree of distress that women experience from their hot flashes appears to be related to their coping resources. This trial is a pilot study to test the effect of participation in a mindfulness-based stress reduction program on hot flash frequency and intensity, as well as menopause-related quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 20, 2006
CompletedFirst Posted
Study publicly available on registry
April 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedOctober 4, 2012
October 1, 2012
7.6 years
April 20, 2006
October 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hot flash frequency and intensity
Baseline, 8 weeks, 24 weeks
Secondary Outcomes (9)
Menopause-related quality of life
Baseline, 8 weeks, 24 weeks
Hot Flash-Related Daily Interference Scale
Baseline, 8 weeks, 24 weeks
Women's Health Initiative (WHI) Insomnia Rating Scale
Baseline, 8 weeks, 24 weeks
5 factor of Mindfulness questionnaire
Baseline, 8 weeks, 24 weeks
Health locus of control
Baseline, 8 weeks, 24 weeks
- +4 more secondary outcomes
Study Arms (1)
MBSR
EXPERIMENTALInterventions
MBSR is an 8-week group-based program of training in mindfulness and its application to the stresses and challenges of everyday life
Eligibility Criteria
You may qualify if:
- Average of 5+ hot flashes per day
- No menses in prior 3 months
- Ages between 40 and 69 years
- English speaking
- Access to a telephone
- Availability for the entire study period
- Agree to maintain usual diet
- Agree to maintain usual exercise habits
- Consent to the study
You may not qualify if:
- Psychiatric illness
- Illness with less than one year life expectancy
- Alcohol use ≥ 2 drinks per day
- Current substance abuse or addiction
- Use of selective estrogen receptor modulator (SERM) medications within the past 3 months
- Use of HT within the past 3 months
- Currently pregnant or breastfeeding
- Ongoing mindfulness meditation practice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Related Publications (1)
Carmody JF, Crawford S, Salmoirago-Blotcher E, Leung K, Churchill L, Olendzki N. Mindfulness training for coping with hot flashes: results of a randomized trial. Menopause. 2011 Jun;18(6):611-20. doi: 10.1097/gme.0b013e318204a05c.
PMID: 21372745DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Carmody, PhD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principle Investigator
Study Record Dates
First Submitted
April 20, 2006
First Posted
April 24, 2006
Study Start
January 1, 2005
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
October 4, 2012
Record last verified: 2012-10