Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT02162862|
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disturbance Fatigue Inflammatory Bowel Disease||Behavioral: Behavioral Counseling Drug: bupropion-SR||Phase 4|
The present study, sponsored by the Crohn's and Colitis Foundation of America, intends to provide information about the feasibility and effectiveness of treatments designed to lessen fatigue and improve sleep among youth with Crohn's disease (CD). Obtaining good sleep is vital in leading a healthy life. For youth with Inflammatory Bowel Disease (IBD), good sleep is key as patients are psychically and psychologically developing and maturing. Previous work suggests that 42% of youth with CD experience poor sleep: difficulty falling asleep, disruption in sleep, early morning awakening, or an absence of feeling refreshed after sleep. Poor sleep can negatively affect ones physical health, mental health, and stress level - each minimizing ones quality of life.
Participants in the study range from 15-30 years old, live with CD, and experience sleep disturbances, targeting 100 participants. Additionally, a healthy control group, 30 participants, is included for comparison. The study contains two phases and takes place over a 12-week period. Phase one involves partaking in 3-8 sessions of Brief Behavioral Therapy for Sleep in IBD (BBTS-I) with study clinician. The treatment teaches self-management techniques and sleep interventions through self-hypnosis/relaxation and reflection. After the treatment, participants are reevaluated. Those who respond well to the treatment are offered 1-2 booster sessions, those who do not show improvement move on to phase two.
In phase two, participants are offered an 8-week course of bupropion-sustained release (BUP-SR). BUP-SR reduces fatigue, depression, and inflammation, and enhances REM sleep. The prescribed dosage will increase from 100mg to 300 mg (150 mg 2x a day). Participant's characterization measures are assessed at the start, midpoint, and finish of the study to measure changes in sleep, fatigue, and mood. Also at these times, blood work is done in hopes of gaining an understanding of the cause of CD. At each of the three assessments, participants are asked to wear a wristwatch device for 7 days that records: total sleep time, wakefulness, and daytime information on napping and sleep hygiene. In addition, participants are asked to keep a brief sleep diary for a 7-day period. This study hopes to provide new treatments to increase the quality of life, primarily by improving sleep in patients with CD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease: A Novel Adjunctive Therapy for Chronic Inflammatory Illness|
|Actual Study Start Date :||July 2013|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
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: Behavioral Counseling
Behavioral counseling + 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: 200-300 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.
Behavioral: Behavioral Counseling
Other Name: Wellbutrin
No Intervention: Healthy Control
The healthy control group includes individuals who are free of physical and psychiatric illness between the ages of 15-30.
- Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm [ Time Frame: Baseline (week 0) to end of study (week 14) ]MFI score range is 0-100. Higher score indicates higher level of fatigue.
- Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm [ Time Frame: Baseline (week 0) to end of study (week 14) ]PSQI score range is 0-21 with higher score indicating greater sleep disturbance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162862
|United States, Pennsylvania|
|Presbyterian University Hospital of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Eva Szigethy, MD, PhD||University of Pittsburgh|