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NCT01933295 · ClinicalTrials.gov registry record · NA
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
A NA study of Menopause, sponsored by Christopher Drake.
- Completed
- Registry status
- NA
- Development phase
- 154
- Enrollment target
- 1
- Study location
NCT01933295: Completed NA study of Menopause, sponsored by Christopher Drake.
NCT01933295 is a NA study of Menopause that has completed, run by Christopher Drake. The registered enrollment target is 154 participants, below the 9,391-participant average among 54 other Menopause trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01933295, a NA study of Menopause, has completed, sponsored by Christopher Drake.
- COMPLETED
- Registry status
- NA
- Development phase
- 154 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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)
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 |
What the finished NCT01933295 record still lists
NCT01933295 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 9,391-participant average among 54 other Menopause trials with a reported enrollment target (98% lower).
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.
NCT01933295 reports a single indexed study location in Michigan.
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.
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).
Who is sponsoring clinical trial NCT01933295?
This trial is sponsored by Christopher Drake, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Menopause
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01933295's enrollment target sits among peer trials
154 11th of 54 higher than 44 of 54 other Menopause trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menopause trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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