Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause
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.
Behavioral: Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause|
- Insomnia Severity Index (ISI) [ Time Frame: ≤2 weeks after therapy completion ] [ Designated as safety issue: No ]
- Hot Flash Severity Diaries [ Time Frame: Baseline, Post treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up ] [ Designated as safety issue: No ]
- Menopause Quality of Life Scale total score [ Time Frame: Baseline, Post-treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||January 2015|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI)
CBTMI is a combination of Cognitive Behavioral Therapy for Insomnia (CBTI) and Cognitive Behavioral Therapy for Hot Flashes (CBTH). 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.
|Behavioral: Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI)|
Placebo Comparator: Enhanced Treatment as Usual/ Information Control
Participants continue with clinical care of their choosing, but will be enhanced by the provision of 3 American Academy of Sleep Medicine (AASM) brochures.
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:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02092844
|Contact: Jessica M Meers, M.A.||firstname.lastname@example.org|
|United States, Texas|
|University of Texas Medical Branch||Not yet recruiting|
|Galveston, Texas, United States, 77555-0144|
|Contact: Jessica M Meers, M.A. 214-796-8492 email@example.com|
|Principal Investigator: Sara Nowakowski, Ph.D.|
|Principal Investigator:||Sara Nowakowski, Ph.D.||University of Texas|