Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317304
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2006-04-20
Brief Title:
Mindfulness Based Stress Reduction for Hot Flashes
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Mindfulness Based Stress Reduction for Hot Flashes
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HFday 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT002910-01 | NIH | None | httpsreporternihgovquickSearchR21AT002910-01 |