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Mindfulness Based Stress Reduction for Hot Flashes

Mindfulness Based Stress Reduction for Hot Flashes

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00317304
Enrollment
110
Registered
2006-04-24
Start date
2005-01-31
Completion date
2012-08-31
Last updated
2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes, Stress

Keywords

Hot flashes, vasomotor symptoms, menopause, mindfulness based stress reduction, meditation

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.

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.

Interventions

BEHAVIORALMindfulness-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

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Hot flash frequency and intensityBaseline, 8 weeks, 24 weeks

Secondary

MeasureTime frame
Hot Flash-Related Daily Interference ScaleBaseline, 8 weeks, 24 weeks
Women's Health Initiative (WHI) Insomnia Rating ScaleBaseline, 8 weeks, 24 weeks
5 factor of Mindfulness questionnaireBaseline, 8 weeks, 24 weeks
Health locus of controlBaseline, 8 weeks, 24 weeks
Menopause-related quality of lifeBaseline, 8 weeks, 24 weeks
Dietary intakeBaseline, 8 weeks, 24 weeks
Compliance with intervention conditionsBaseline, 8 weeks, 24 weeks
HADSBaseline, 8 weeks, 24 weeks
Perceived stressBaseline, 8 weeks, 24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026