Trial Outcomes & Findings for Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy (NCT NCT01091974)
NCT ID: NCT01091974
Last Updated: 2017-02-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
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).
Results posted on
2017-02-09
Participant Flow
138 Patients were consented of which 114 were eligible.
18 Withdrew prior to randomization (3 ceased responding to contacts, 4 changed mind , 3 began or restarted sleep medication, 4 did not complete baseline measures, 1 did not receive approval from physician to participate, 1 found the diaries too much trouble, 1 did not want to take study medication, and 1 had a family emergency).
Participant milestones
| Measure |
Arm 1 - (CBT-I) + Placebo
Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
2 - CBT-I + Armodafinil
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
3- Placebo Only
Placebo Comparator: Placebo for 47 days
|
4 - Armodafinil Only
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
25
|
24
|
|
Overall Study
COMPLETED
|
19
|
18
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
6
|
7
|
Reasons for withdrawal
| Measure |
Arm 1 - (CBT-I) + Placebo
Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
2 - CBT-I + Armodafinil
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
3- Placebo Only
Placebo Comparator: Placebo for 47 days
|
4 - Armodafinil Only
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
|
|---|---|---|---|---|
|
Overall Study
Did not start intervention
|
3
|
1
|
3
|
1
|
|
Overall Study
resumed sleep medication
|
0
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
2
|
|
Overall Study
side-effects
|
1
|
1
|
0
|
2
|
Baseline Characteristics
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Baseline characteristics by cohort
| Measure |
1 - CBT-I + Placebo
n=24 Participants
CBT-I and placebo
Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
2 - CBT-I + Armodafinil
n=23 Participants
CBT-I + Armodafinil
armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
3 - Placebo Only
n=25 Participants
Placebo only
Placebo Comparator: Placebo for 47 days
|
4 - Armodafinil Only
n=24 Participants
Armodafinil only
armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
56 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
52 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
57 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
56.1 years
STANDARD_DEVIATION 10.0 • n=21 Participants
|
|
Gender
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
25 participants
n=5 Participants
|
24 participants
n=4 Participants
|
96 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1 - (CBT-I) + Placebo
n=24 Participants
Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
2 - CBT-I + Armodafinil
n=23 Participants
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
3- Placebo Only
n=25 Participants
Placebo Comparator: Placebo for 47 days
|
4 - Armodafinil Only
n=24 Participants
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
|
|---|---|---|---|---|
|
Change in Insomnia Severity Index From Baseline to Post-intervention
|
-4.93 units on a scale
Standard Error 1.85
|
-6.36 units on a scale
Standard Error 1.84
|
1.04 units on a scale
Standard Error 1.89
|
-1.43 units on a scale
Standard Error 1.78
|
SECONDARY outcome
Timeframe: 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).Population: Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.
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.
Outcome measures
| Measure |
Arm 1 - (CBT-I) + Placebo
n=24 Participants
Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
2 - CBT-I + Armodafinil
n=23 Participants
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
3- Placebo Only
n=24 Participants
Placebo Comparator: Placebo for 47 days
|
4 - Armodafinil Only
n=24 Participants
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
|
|---|---|---|---|---|
|
Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .
|
2.041 units on a scale
Standard Error 0.411
|
1.209 units on a scale
Standard Error 0.364
|
2.971 units on a scale
Standard Error 0.534
|
3.167 units on a scale
Standard Error 0.456
|
Adverse Events
Arm 1 - (CBT-I) + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 - CBT-I + Armodafinil
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3- Placebo Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 - Armodafinil Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - (CBT-I) + Placebo
n=24 participants at risk
Placebo Comparator: Placebo for 47 days
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
2 - CBT-I + Armodafinil
n=23 participants at risk
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
|
3- Placebo Only
n=25 participants at risk
Placebo Comparator: Placebo for 47 days
|
4 - Armodafinil Only
n=24 participants at risk
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
|
|---|---|---|---|---|
|
General disorders
Headache
|
0.00%
0/24 • Participants were followed throughout the study duration, for up to 24 weeks
|
8.7%
2/23 • Number of events 2 • Participants were followed throughout the study duration, for up to 24 weeks
|
0.00%
0/25 • Participants were followed throughout the study duration, for up to 24 weeks
|
0.00%
0/24 • Participants were followed throughout the study duration, for up to 24 weeks
|
|
Nervous system disorders
Numbness/tingling
|
0.00%
0/24 • Participants were followed throughout the study duration, for up to 24 weeks
|
4.3%
1/23 • Number of events 1 • Participants were followed throughout the study duration, for up to 24 weeks
|
0.00%
0/25 • Participants were followed throughout the study duration, for up to 24 weeks
|
0.00%
0/24 • Participants were followed throughout the study duration, for up to 24 weeks
|
Additional Information
Joseph A. Roscoe Ph.D.
University of Rochester Medical Center
Phone: (585) 275-9962
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place