Mindfulness Based Stress Reduction for Hot Flashes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Carmody, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00317304
First received: April 20, 2006
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hot Flashes
Stress
Behavioral: Mindfulness-based stress reduction
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness Based Stress Reduction for Hot Flashes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Hot flash frequency and intensity [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Menopause-related quality of life [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Hot Flash-Related Daily Interference Scale [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Women's Health Initiative (WHI) Insomnia Rating Scale [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • 5 factor of Mindfulness questionnaire [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Health locus of control [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Perceived stress [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Compliance with intervention conditions [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • HADS [ Time Frame: Baseline, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: January 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBSR Behavioral: Mindfulness-based stress reduction
MBSR is an 8-week group-based program of training in mindfulness and its application to the stresses and challenges of everyday life
Other Name: MBSR

Detailed Description:

The majority of women experience vasomotor symptoms (VMS) such as hot flashes (HF) and night sweats as they transition through menopause, and a substantial minority experience considerable distress and diminished role functioning. Until recently most women found relief through hormone therapy (HT), but concern about the health risks associated with HT has left women with few effective and safe choices for relief from their symptoms other than their own coping strategies. A variety of results from both population and laboratory studies suggest that stress and HF are correlated and that HF are more severe in women with lower coping abilities, but evidence is far from conclusive. Consequently, investigators have called for trials to evaluate the effect of stress reduction interventions on HF. Mindfulness-Based Stress Reduction (MBSR) is a widely available manualized program shown to be an effective adjunctive intervention in reducing medical symptoms and psychological distress for a wide range of stress-related disorders. In a small preliminary study using MBSR we found reductions in HF severity scores and increases in menopause-related quality of life (QOL). This R21 proposal is for a pilot randomized trial of MBSR compared to a wait-list control group for 120 menopausal women experiencing seven or more HF/day of moderate to severe intensity. It aims to:

  1. assess feasibility of recruitment, adherence to program intervention, and compliance with assessment instruments in preparation for a larger RCT; and
  2. provide preliminary estimates of efficacy of the effects of MBSR in reducing self-reported HF frequency and intensity and improving QOL.

In addition, we will use sternal skin conductance as an established objective measure of VMS in a subgroup of 15 women in each arm to test feasibility and obtain information on how objectively measured HF are related to self-reported HF in this setting. Women will be assessed at baseline, at the end of the eight-week MBSR course, and at three months after the end of the course. A secondary aim is to explore whether treatment group differences of HF frequency and intensity and QOL are explained by changes in perceived stress, health-related locus of control and mindfulness. It is anticipated that results from this pilot study will provide data needed to plan a larger more definitive randomized trial on the effect of MBSR on HF frequency and intensity and on the ability to cope with these symptoms.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317304

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: James Carmody, PhD University of Massachusetts, Worcester
  More Information

No publications provided by University of Massachusetts, Worcester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Carmody, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00317304     History of Changes
Other Study ID Numbers: R21 AT002910-01, R21AT002910-01
Study First Received: April 20, 2006
Last Updated: October 3, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Massachusetts, Worcester:
Hot flashes
vasomotor symptoms
menopause
mindfulness based stress reduction
meditation

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014