Trial · NCT01091974

Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

NCT01091974, Phase 2, Completed, University of Rochester; results first posted 2015-03-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy. Trials, record NCT01091974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01091974

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
NCT number: NCT01091974
Status: Completed
Phases: Phase 2
Enrollment: 138 participants, actual
Lead sponsor: University of Rochester
Conditions: Insomnia, Fatigue, Breast Cancer
Interventions: armodafinil, Placebo Comparator, CBT-I
First posted: 2010-03-24
Last updated: 2017-02-09
Results first posted: 2015-03-13

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Insomnia Severity Index From Baseline to Post-intervention	ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).	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.
Secondary	Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .	ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).	The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue "now," and fatigue at its "worst" and "usual" for the last 24 hours. The 11-point scales are bounded by 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = "does not interfere" and 10 = "interferes completely." A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Insomnia Severity Index From Baseline to Post-intervention	ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).		units on a scale	MEAN
SECONDARY	Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .	ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).	Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Insomnia Severity Index From Baseline to Post-intervention	Arm 1 - (CBT-I) + Placebo	-4.93	Standard Error 1.85	units on a scale
Change in Insomnia Severity Index From Baseline to Post-intervention	2 - CBT-I + Armodafinil	-6.36	Standard Error 1.84	units on a scale
Change in Insomnia Severity Index From Baseline to Post-intervention	3- Placebo Only	1.04	Standard Error 1.89	units on a scale
Change in Insomnia Severity Index From Baseline to Post-intervention	4 - Armodafinil Only	-1.43	Standard Error 1.78	units on a scale
Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .	Arm 1 - (CBT-I) + Placebo	2.041	Standard Error 0.411	units on a scale
Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .	2 - CBT-I + Armodafinil	1.209	Standard Error 0.364	units on a scale
Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .	3- Placebo Only	2.971	Standard Error 0.534	units on a scale
Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .	4 - Armodafinil Only	3.167	Standard Error 0.456	units on a scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1 - (CBT-I) + Placebo	24
Overall Study	STARTED	2 - CBT-I + Armodafinil	23
Overall Study	STARTED	3- Placebo Only	25
Overall Study	STARTED	4 - Armodafinil Only	24
Overall Study	COMPLETED	Arm 1 - (CBT-I) + Placebo	19
Overall Study	COMPLETED	2 - CBT-I + Armodafinil	18
Overall Study	COMPLETED	3- Placebo Only	19
Overall Study	COMPLETED	4 - Armodafinil Only	17
Overall Study	NOT COMPLETED	Arm 1 - (CBT-I) + Placebo	5
Overall Study	NOT COMPLETED	2 - CBT-I + Armodafinil	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	General disorders	Arm 1 - (CBT-I) + Placebo	0	24	0
other	Headache	General disorders	2 - CBT-I + Armodafinil	2	23	2
other	Headache	General disorders	3- Placebo Only	0	25	0
other	Headache	General disorders	4 - Armodafinil Only	0	24	0
other	Numbness/tingling	Nervous system disorders	Arm 1 - (CBT-I) + Placebo	0	24	0
other	Numbness/tingling	Nervous system disorders	2 - CBT-I + Armodafinil	1	23	1
other	Numbness/tingling	Nervous system disorders	3- Placebo Only	0	25	0
other	Numbness/tingling	Nervous system disorders	4 - Armodafinil Only	0	24	0

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1 - (CBT-I) + Placebo
Total, all-cause mortality	2 - CBT-I + Armodafinil
Total, all-cause mortality	3- Placebo Only
Total, all-cause mortality	4 - Armodafinil Only
Total, other adverse events	Arm 1 - (CBT-I) + Placebo	0	24
Total, other adverse events	2 - CBT-I + Armodafinil	3	23
Total, other adverse events	3- Placebo Only	0	25
Total, other adverse events	4 - Armodafinil Only	0	24
Total, serious adverse events	Arm 1 - (CBT-I) + Placebo	0	24
Total, serious adverse events	2 - CBT-I + Armodafinil	0	23

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25452447	DERIVED	PubMed
30621831	DERIVED	PubMed
41170811	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01CA126968	CBT +/- Modafinil for Insomnia and Fatigue following Chemotherapy	ROSCOE, JOSEPH A	UNIVERSITY OF ROCHESTER	NATIONAL CANCER INSTITUTE	2008 to 2012

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01091974

GET https://conductscience.org/api/trials/v1/NCT01091974/registered

API reference For AI assistants