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Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

NCT01933295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-02-22

Study results available
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Summary

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.

Conditions

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

BEHAVIORAL

Sleep Education

BEHAVIORAL

Sleep Restriction Therapy

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Wayne State University

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Christopher Drake

    lead OTHER

Principal Investigators

  • Christopher Drake, PhD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01933295 on ClinicalTrials.gov