N/A
Completed N=154
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Source: ClinicalTrials.gov NCT01933295 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Diary Based Sleepiness — 5.01; 5.13; 4.87; 4.72 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diary Based Sleepiness |
5.01; 5.13; 4.87; 4.72; 4.36; 4.09 | — |
| SECONDARY Fatigue Severity Scale (FSS). |
32.50; 31.78; 33.28; 32.32; 28.20; 29.90 | — |
| SECONDARY Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale |
52.70; 52.50; 52.76; 52.10; 61.90; 61.33 | — |
Eligibility Criteria
Inclusion Criteria
- post-menopausal insomnia
Exclusion Criteria
- unstable medical conditions
Data sourced from ClinicalTrials.gov (NCT01933295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.