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A phase 2 trial of Cognitive behavioural therapy for insomnia in Breast cancer, run by University of Rochester, completed.
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy is a phase 2 interventional study registered as NCT01091974 by University of Rochester, with 138 participants recorded, started 2008-02 and reaching its primary completion in 2013-04. Interventions recorded: armodafinil, Placebo Comparator, CBT-I. Conditions recorded: Insomnia, Fatigue, Breast Cancer.
Linked to the technology Cognitive behavioural therapy for insomnia because the registry names it ("cbt i") among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
138 enrolled.
SE 1.85; Figures from the ClinicalTrials.gov results section (first posted 2015-03-13), not from a publication · SE 1.84 · SE 1.89 · SE 1.78
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Change in Insomnia Severity Index From Baseline to Post-interventionprimary | Arm 1 - (CBT-I) + Placebo | 24 | -4.93 units on a scale | - | - | link |
| 2 - CBT-I + Armodafinil | 23 | -6.36 units on a scale | ||||
| 3- Placebo Only | 25 | 1.04 units on a scale | ||||
| 4 - Armodafinil Only | 24 | -1.43 units on a scale |
Shares Breast cancer (all types) and the tag pipeline.
Shares Breast cancer (all types) and the tag pipeline.
Shares Breast cancer (all types) and the tag pipeline.
Shares Breast cancer (all types) and the tag pipeline.
Shares Breast cancer (all types) and the tag pipeline.
Shares Breast cancer (all types) and the tag pipeline.
Shares Breast cancer (all types) and the tag pipeline.
Shares Breast cancer (all types) and the tag pipeline.