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NCT01091974 · ClinicalTrials.gov registry record · Phase 2
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
NCT01091974: Completed Phase 2 study, sponsored by University of Rochester.
NCT01091974 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 138 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01091974, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
Study Summary
This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.
Primary Outcome
The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.
Interventions
- DRUG Placebo Comparator
- BEHAVIORAL CBT-I
- DRUG armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT01091974 record still lists
NCT01091974 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo Comparator is the first listed.
NCT01091974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01091974 about?
NCT01091974 is a clinical study titled "Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy". This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.
What is the current status of trial NCT01091974?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2008-02. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01091974?
The interventions under investigation include: Placebo Comparator (DRUG), CBT-I (BEHAVIORAL), armodafinil (DRUG).
Who is sponsoring clinical trial NCT01091974?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01091974's enrollment target sits among peer trials
138 525th of 2000 higher than 1,474 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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