Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162862
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Eva Szigethy, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sleep Disturbance
Fatigue
Inflammatory Bowel Disease
Interventions Behavioral: Behavioral Counseling
Drug: bupropion-SR
Enrollment 99
Recruitment Details Recruitment took place at the Digestive Disorders Clinic at Presbyterian Hospital in Pittsburgh, PA. Recruitment began 11/13/13 and ended 2/18/16.
Pre-assignment Details  
Arm/Group Title Healthy Control Behavioral Counseling Behavioral Counseling + Bupropion
Hide Arm/Group Description The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.

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

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.
Period Title: Overall Study
Started 31 35 33
Completed 31 24 29
Not Completed 0 11 4
Reason Not Completed
Lost to Follow-up             0             11             0
Subject did not feel the med was needed             0             0             4
Arm/Group Title Behavioral Counseling Control Group Behavioral Counseling + Bupropion Total
Hide Arm/Group Description

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

Individuals free of physical and psychiatric illness. 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 of all reporting groups
Overall Number of Baseline Participants 35 31 33 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 31 participants 33 participants 99 participants
<=18 years
4
  11.4%
6
  19.4%
5
  15.2%
15
  15.2%
Between 18 and 65 years
31
  88.6%
25
  80.6%
28
  84.8%
84
  84.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 31 participants 33 participants 99 participants
23.7  (4.7) 23.5  (4.3) 23.96  (5.76) 23.7  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 31 participants 33 participants 99 participants
Female
22
  62.9%
19
  61.3%
19
  57.6%
60
  60.6%
Male
13
  37.1%
12
  38.7%
14
  42.4%
39
  39.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 31 participants 33 participants 99 participants
35 31 33 99
1.Primary Outcome
Title Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm
Hide Description MFI score range is 0-100. Higher score indicates higher level of fatigue.
Time Frame Baseline (week 0) to end of study (week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Counseling Healthy Control Behavioral Counseling + Bupropion
Hide Arm/Group Description:

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

The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.

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

Overall Number of Participants Analyzed 35 31 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.727  (13.843) -1.828  (5.8) 16.367  (13.962)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavioral Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Behavioral Counseling + Bupropion
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .102
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm
Hide Description PSQI score range is 0-21 with higher score indicating greater sleep disturbance.
Time Frame Baseline (week 0) to end of study (week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Counseling Healthy Control Behavioral Counseling + Bupropion
Hide Arm/Group Description:

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

The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.

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

Overall Number of Participants Analyzed 35 31 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.857  (3.928) -.154  (1.69) 6.571  (3.696)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavioral Counseling
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Healthy Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .646
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Behavioral Counseling + Bupropion
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame The study was conducted over a period of 2 years. Each subject participated in the study for 4 months. No adverse events were reported for any subjects during their time in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Control Behavioral Counseling Behavioral Counseling + Bupropion
Hide Arm/Group Description The healthy control group included individuals who were free of physical and psychiatric illness between the ages of 15-30.

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

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.
All-Cause Mortality
Healthy Control Behavioral Counseling Behavioral Counseling + Bupropion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/35 (0.00%)   0/33 (0.00%) 
Hide Serious Adverse Events
Healthy Control Behavioral Counseling Behavioral Counseling + Bupropion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/35 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Control Behavioral Counseling Behavioral Counseling + Bupropion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/35 (0.00%)   0/33 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eva Szigethy
Organization: University of Pittsburgh Medical Center
Phone: 412-802-6696
EMail: szigethye@upmc.edu
Layout table for additonal information
Responsible Party: Eva Szigethy, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02162862    
Other Study ID Numbers: CCFA 13050045
First Submitted: June 11, 2014
First Posted: June 13, 2014
Results First Submitted: June 28, 2017
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017