Mindfulness Based Stress Reduction for Hot Flashes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness Based Stress Reduction for Hot Flashes

Conditions
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Stress, Hot Flashes

Intervention / Treatment
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* Behavioral: Mindfulness-based stress reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR<br> | Behavioral: Mindfulness-based stress reduction<br>* MBSR is an 8-week group-based program of training in mindfulness and its application to the stresses and challenges of everyday life<br>* Other names: MBSR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flash frequency and intensity |  | Baseline, 8 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Perceived stress |  | Baseline, 8 weeks, 24 weeks | 
| Dietary intake |  | Baseline, 8 weeks, 24 weeks | 
| Compliance with intervention conditions |  | Baseline, 8 weeks, 24 weeks | 
| HADS |  | Baseline, 8 weeks, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot flashes, vasomotor symptoms, menopause, mindfulness based stress reduction, meditation