Mindfulness Based Stress Reduction for Hot Flashes

University of Massachusetts, Worcester

Status and phase

Completed

Phase 1

Conditions

Hot Flashes

Stress

Treatments

Behavioral: Mindfulness-based stress reduction

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00317304

R21AT002910-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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:

assess feasibility of recruitment, adherence to program intervention, and compliance with assessment instruments in preparation for a larger RCT; and
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.

Enrollment

110 patients

Sex

Female

Ages

40 to 69 years old

Volunteers

Accepts Healthy Volunteers

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