Trial Outcomes & Findings for Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease (NCT NCT02162862)
NCT ID: NCT02162862
Last Updated: 2017-09-13
Results Overview
MFI score range is 0-100. Higher score indicates higher level of fatigue.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
99 participants
Primary outcome timeframe
Baseline (week 0) to end of study (week 14)
Results posted on
2017-09-13
Participant Flow
Recruitment took place at the Digestive Disorders Clinic at Presbyterian Hospital in Pittsburgh, PA. Recruitment began 11/13/13 and ended 2/18/16.
Participant milestones
| Measure |
Healthy Control
The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
|
Behavioral Counseling
Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.
Behavioral Counseling
Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
bupropion-SR
|
Behavioral Counseling + Bupropion
Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I) plus bupropion-SR (bupropion-Sustained Release). 8 -week trial of bupropion-SR (target dose: 200-300mg/day). Bupropion-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement sleep (REM) in medically ill populations.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
35
|
33
|
|
Overall Study
COMPLETED
|
31
|
24
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
11
|
4
|
Reasons for withdrawal
| Measure |
Healthy Control
The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
|
Behavioral Counseling
Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.
Behavioral Counseling
Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
bupropion-SR
|
Behavioral Counseling + Bupropion
Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I) plus bupropion-SR (bupropion-Sustained Release). 8 -week trial of bupropion-SR (target dose: 200-300mg/day). Bupropion-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement sleep (REM) in medically ill populations.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
11
|
0
|
|
Overall Study
Subject did not feel the med was needed
|
0
|
0
|
4
|
Baseline Characteristics
Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease
Baseline characteristics by cohort
| Measure |
Behavioral Counseling
n=35 Participants
Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.
Behavioral Counseling
|
Control Group
n=31 Participants
Individuals free of physical and psychiatric illness.
|
Behavioral Counseling + Bupropion
n=33 Participants
Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I) plus bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
84 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
23.7 years
STANDARD_DEVIATION 4.7 • n=93 Participants
|
23.5 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
23.96 years
STANDARD_DEVIATION 5.76 • n=27 Participants
|
23.7 years
STANDARD_DEVIATION 4.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=93 Participants
|
31 participants
n=4 Participants
|
33 participants
n=27 Participants
|
99 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0) to end of study (week 14)MFI score range is 0-100. Higher score indicates higher level of fatigue.
Outcome measures
| Measure |
Behavioral Counseling
n=35 Participants
Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.
Behavioral Counseling
Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
bupropion-SR
|
Healthy Control
n=31 Participants
The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
|
Behavioral Counseling + Bupropion
n=33 Participants
8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
bupropion-SR
|
|---|---|---|---|
|
Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm
|
18.727 units on a scale
Standard Deviation 13.843
|
-1.828 units on a scale
Standard Deviation 5.8
|
16.367 units on a scale
Standard Deviation 13.962
|
PRIMARY outcome
Timeframe: Baseline (week 0) to end of study (week 14)PSQI score range is 0-21 with higher score indicating greater sleep disturbance.
Outcome measures
| Measure |
Behavioral Counseling
n=35 Participants
Brief Behavioral Therapy for Sleep Disruption in IBD (BBTS-I). This treatment phase focuses on treating insomnia, a nighttime component of sleep disturbance delivered in 1:1 sessions which can be completed in person or by phone, except for initial session.
Behavioral Counseling
Within this arm, some participants offered bupropion-SR (bupropion-Sustained Release). 8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
bupropion-SR
|
Healthy Control
n=31 Participants
The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.
|
Behavioral Counseling + Bupropion
n=33 Participants
8-week trial of bupropion-SR (target dose: 200-300 mg/day). bup-SR, a noradrenergic dopaminergic reuptake inhibitor (NDRI). NDRI has been shown to improve fatigue and rapid eye movement-sleep (REM) in medically ill populations.
bupropion-SR
|
|---|---|---|---|
|
Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm
|
4.857 units on a scale
Standard Deviation 3.928
|
-.154 units on a scale
Standard Deviation 1.69
|
6.571 units on a scale
Standard Deviation 3.696
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Counseling + Bupropion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Eva Szigethy
University of Pittsburgh Medical Center
Phone: 412-802-6696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place