Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

February 21, 2023 updated by: Christopher Drake
Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.

Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.

Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).

Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.

Study Type

Interventional

Enrollment (Actual)

154

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
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

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

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • post-menopausal insomnia

Exclusion Criteria:

  • unstable medical conditions

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sleep Education
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
Behavioral: Sleep Education
Experimental: Cognitive Behavioral Therapy for Insomnia
Behavioral treatment (5 component)
Behavioral: Cognitive Behavioral Therapy for Insomnia
Experimental: Sleep Restriction Therapy
Brief sleep restriction therapy.
Behavioral: Sleep Restriction Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diary Based Sleepiness
Time Frame: 8 months
Diaries were based on the consensus sleep diaries but were modified to also measure patient sleepiness over the past 24 hours on a 0 "none" to 10 "highest" scale. Scores in this study represent the daily mean for sleepiness ratings for each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Severity Scale (FSS).
Time Frame: 8 months

Scores range from 9 to 63, with higher scores indicating greater fatigue, and scores above 36 indicate severe fatigue.

Data collected at pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline).
8 months
Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale
Time Frame: 8 months

Domain scores range from 0 to 100 with higher scores indicating better quality of life.

Data collected at each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)
8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reported Sleep (Diary)
Time Frame: 8 months

Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up. For each participant, self report sleep diaries will be measured in the home nightly throughout the 2-week baseline, treatment protocols, during the 2 weeks immediately post-treatment and for 2 weeks during follow up assessment at 6 months post treatment.

Home based measures (Diary): Wake after sleep onset; sleep efficiency; total sleep time; sleep latency; number of awakenings
8 months

Collaborators and Investigators

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

Sponsor

Christopher Drake

Collaborators

National Institute of Nursing Research (NINR)
Wayne State University
University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

September 6, 2012

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NR013959
  • R01NR013959-01 (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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