NCT02162862

Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease: A Novel Adjunctive Therapy for Chronic Inflammatory Illness

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Eva Szigethy · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if either a targeted type of talk therapy (Phase I) or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals with Inflammatory Bowel Disease (IBD).

Detailed description

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.

Conditions

• Sleep Disturbance
• Fatigue
• Inflammatory Bowel Disease

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Counseling
DRUG	bupropion-SR

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-06-30
• Completion: 2016-06-30
• First posted: 2014-06-13
• Last updated: 2017-09-13
• Results posted: 2017-09-13

Locations

2 sites across 1 country: United States