NCT01052454

Brief Summary

This is a study to determine if participation in a mindfulness-based stress reduction program is feasible for women experiencing five or more hot flashes/day, and whether it affects either the frequency and/or intensity of their hot flashes, or the degree of bother they experience from them

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

3.7 years

First QC Date

January 18, 2010

Last Update Submit

January 19, 2010

Conditions

Vasomotor Symptoms

Keywords

hot flashesmindfulnessstress

Outcome Measures

Primary Outcomes (1)

  • Hot Flash intensity/bother

Study Arms (2)

Wait list

NO INTERVENTION

Women assigned to the waitlist have the opportunity of taking the MBSR program at no cost following final study assessment

Mindfulness-based stress reduction

EXPERIMENTAL

Women in the MBSR arm attend eight weekly MBSR classes

Behavioral: Mindfulness-based stress reduction

Interventions

Mindfulness-based stress reductionBEHAVIORAL

Participants in the MBSR arm attend eight weekly classes.

Also known as: MBSR
Mindfulness-based stress reduction

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women experiencing 5 or more hot flashes/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2010

First Posted

January 20, 2010

Study Start

September 1, 2005

Primary Completion

May 1, 2009

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

US(1)