Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

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.

Inclusion Criteria:

- IBD Group:

- Biopsy confirmed Crohn's Disease

- Qualifying scores on Multidimensional Fatigue Inventory and Pittsburgh Sleep
Quality Index

- Healthy Volunteer Group:

- Does not meet any exclusion criteria

Exclusion Criteria:

- IBD Group:

- Meeting criteria for active alcohol or substance abuse or dependence

- Current ongoing treatment with Wellbutrin

- Females who are pregnant or plan to become pregnant within three months

- Sleep disorder such as apnea, restless leg syndrome or use of Continuous
positive airway pressure therapy (C-PAP)/Bilevel positive airway pressure
(Bi-PAP)

- Current IBD flare requiring hospitalization with intravenous steroid treatment

- Other acute medical conditions or a history of chronic inflammatory condition
other than IBD

- Hemoglobin <10 with age and gender adjustments

- History of seizure disorder

- Acute infection within seven days

- Healthy Volunteer Group:

- History or current episode of psychiatric disorder by Diagnositic and
Statistical Manual (DSM-IV)

- Current ongoing treatment with psychoactive medications

- Medications for sleep in previous two weeks

- Females who are pregnant or plan to become pregnant within three months

- History of IBD, epilepsy, rheumatoid arthritis, lupus

- Sleep disorder such as apnea, restless leg syndrome or use of Continuous
positive airway pressure therapy (C-PAP)/Bilevel positive airway pressure
(Bi-PAP)