NCT02092844

Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of the current study is to evaluate the effectiveness of a Cognitive Behavioral Therapy intervention in the treatment of menopause-associated insomnia and nocturnal hot flashes.

Detailed description

This study aims to develop and evaluate a primary care-based intervention for insomnia and nocturnal hot flashes (nHF) in peri- and postmenopausal women. Menopause-associated insomnia is associated with adverse consequences including reduced quality of life, increased health care utilization, and risk for psychiatric disorders and medical conditions. The poor benefit/risk ratio of estrogen and progesterone replacement therapy and concerns about long-term effects of sedative hypnotics has left women desperate for new approaches to resolve menopause-related health problems, including poor sleep. The proposed intervention aims to develop and evaluate a much-needed safe treatment of menopause-associated insomnia that combines and enhances cognitive behavioral therapies for insomnia and hot flashes. To maximize the public health impact, improve access, and reduce treatment barriers (stigma and transportation issues), we propose to evaluate the efficacy and effectiveness of the intervention delivered by nurses in gynecology clinics, where women receive routine care. Primary outcomes, for which the study is optimally designed and sufficiently powered, are subjectively- and objectively-measured sleep and nHF. The Aims of this research are to: 1. To explore feasibility, acceptability (willingness to be randomized and dropout rates) of CBTMI, and indications of efficacy/effectiveness of CBTMI in a randomized, placebo-controlled, pilot study. 2. To explore the effects of CBTMI on the number and duration of arousals/awakenings that follow nHFs. If effective, the intervention has the potential to improve the quality of life in peri- and postmenopausal women and reduce the significant costs to society.

Conditions

• Menopause
• Insomnia
• Hot Flashes

Interventions

Type	Name	Description
BEHAVIORAL	CBT for Menopausal Insomnia (CBTMI)	Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI) includes education about sleep, sleep restriction, stimulus control, cognitive restructuring of sleep interfering thoughts, and relapse prevention; while also addressing women's beliefs about and reactions to hot flashes.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2014-03-20
• Last updated: 2017-05-12

Locations

1 site across 1 country: United States