Mindfulness Based Stress Reduction for Hot Flashes
Condition: Hot Flashes; Stress
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Mindfulness-based stress reduction
Intervention type(s): Behavioral
Intervention description(s): MBSR is an 8-week group-based program of training in mindfulness and its application to the stresses and challenges of everyday life
Other intervention name(s): MBSR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hot flashes; vasomotor symptoms; menopause; mindfulness based stress reduction; meditation