Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

May 11, 2017 updated by: The University of Texas Medical Branch, Galveston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555-0144
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women in menopausal transition (defined by standardized criteria as variable cycle length seven days different from their normal cycle or >2 skipped cycles and an interval of amenorrhea of 2-12 months) or postmenopausal (defined as >12 months since last menstrual period).
  • Meet Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for insomnia assessed by Duke Structured Interview for Sleep Disorders.
  • Score >14 on the Insomnia Severity Index (ISI) or >8 on the Pittsburgh Sleep Quality Index (PSQI).
  • Have at least one nocturnal hot flash/night sweat on 3 or more nights a week (based on 2 weeks of daily hot flash diaries).

Exclusion Criteria:

  • Chemotherapy/radiation-induced menopause.
  • Presence of any unstable medical disorder assessed by medical tracking form.
  • Traumatic brain injury or cognitive impairment defined by a score < 25 on Mini Mental Status Exam.
  • Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in past 3 years).
  • Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder, assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities will not be excluded).
  • Recent initiation/change in existing treatments that may impact sleep or nocturnal hot flashes (recency is defined by: < 4 weeks for antidepressant, < 16 weeks for any psychotherapy, and <8 weeks for estrogen, progestin, or androgen).
  • As needed use of hypnotic, over-the-counter, or herbal supplements known to affect sleep or hot flashes.
  • The following comorbid sleep disorders based on structured diagnostic interview: narcolepsy, circadian rhythm disorder, restless less syndrome, periodic leg movement disorder (PLMD), obstructive sleep apnea (OSA), or positive screening PLMD (PLMI > 15) or OSA (AHI > 15) on polysomnography (PSG) following screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT for Menopausal Insomnia (CBTMI)
CBTMI is a combination of Cognitive Behavioral Therapy for Insomnia (CBTI) and Cognitive Behavioral Therapy for Hot Flashes (CBTH).
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.
Placebo Comparator: Enhanced Treatment as Usual
In the Enhanced Treatment as Usual/Information Control group, participants continue with clinical care of their choosing, but will be enhanced by the provision of 3 American Academy of Sleep Medicine (AASM) brochures.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insomnia Severity Index (ISI)
Time Frame: ≤2 weeks after therapy completion
≤2 weeks after therapy completion
Hot Flash Severity Diaries
Time Frame: Baseline, Post treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up
Baseline, Post treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Menopause Quality of Life Scale total score
Time Frame: Baseline, Post-treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up
Baseline, Post-treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Sara Nowakowski, Ph.D., University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-102
  • 1K23NR014008 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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