Mindfulness Based Stress Reduction for Hot Flashes

Stress Clinical Trial

Official title:

Mindfulness Based Stress Reduction for Hot Flashes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317304
• Other study ID #: R21AT002910-01
• Secondary ID: R21AT002910-01
• Status: Completed
• Phase: Phase 1
• First received: April 20, 2006
• Last updated: October 3, 2012
• Start date: January 2005
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot flash frequency and intensity		Baseline, 8 weeks, 24 weeks	No
Secondary	Menopause-related quality of life		Baseline, 8 weeks, 24 weeks	No
Secondary	Hot Flash-Related Daily Interference Scale		Baseline, 8 weeks, 24 weeks	No
Secondary	Women's Health Initiative (WHI) Insomnia Rating Scale		Baseline, 8 weeks, 24 weeks	No
Secondary	5 factor of Mindfulness questionnaire		Baseline, 8 weeks, 24 weeks	No
Secondary	Health locus of control		Baseline, 8 weeks, 24 weeks	No
Secondary	Perceived stress		Baseline, 8 weeks, 24 weeks	No
Secondary	Dietary intake		Baseline, 8 weeks, 24 weeks	No
Secondary	Compliance with intervention conditions		Baseline, 8 weeks, 24 weeks	No
Secondary	HADS		Baseline, 8 weeks, 24 weeks	No