{"entity":{"id":"nct01091974","kind":"trial","name":"Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy","aka":[],"tldr":"A phase 2 trial of Cognitive behavioural therapy for insomnia in Breast cancer, run by University of Rochester, completed.","summary":"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.\n\nLinked 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.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01091974","url":"https://clinicaltrials.gov/study/NCT01091974"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["cbt-insomnia-cancer"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01091974","phase":"2","setting":"Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy","sponsor":"University of Rochester","started":"2008-02","yearReported":2015,"enrolled":138,"enrolledBasis":"registry","outcomes":[{"endpoint":"Change in Insomnia Severity Index From Baseline to Post-intervention","primary":true,"unit":"units on a scale","arms":[{"name":"Arm 1 - (CBT-I) + Placebo","n":24,"value":-4.93,"note":"SE 1.85; Figures from the ClinicalTrials.gov results section (first posted 2015-03-13), not from a publication"},{"name":"2 - CBT-I + Armodafinil","n":23,"value":-6.36,"note":"SE 1.84"},{"name":"3- Placebo Only","n":25,"value":1.04,"note":"SE 1.89"},{"name":"4 - Armodafinil Only","n":24,"value":-1.43,"note":"SE 1.78"}],"source":"https://clinicaltrials.gov/study/NCT01091974?tab=results"}]},"route":"/trials/nct01091974/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"technology":[{"id":"cbt-insomnia-cancer","kind":"technology","name":"Cognitive behavioural therapy for insomnia (CBT-I)","route":"/technologies/cbt-insomnia-cancer/"}]}}