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Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
NCT01933295 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
- BEHAVIORAL Sleep Restriction Therapy
- BEHAVIORAL Sleep Education
Study Locations (1)
Michigan
- Henry Ford Hospital — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2018-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01933295
The ClinicalTrials.gov registry entry for NCT01933295 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Christopher Drake, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Menopause appearing as the primary indexed condition, and to 3 interventions — of which Cognitive Behavioral Therapy for Insomnia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01933295 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01933295 about?
NCT01933295 is a clinical study titled "Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes". 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 transit...
What is the current status of trial NCT01933295?
This trial is currently completed. It is a NA study. The enrollment target is 154 participants. The study started on 2014-03-01. Estimated completion is 2018-12-31.
What conditions does trial NCT01933295 study?
This clinical trial studies the following conditions: Menopause. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01933295?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL), Sleep Restriction Therapy (BEHAVIORAL), Sleep Education (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01933295?
This trial is sponsored by Christopher Drake, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01933295 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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