Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

• Status: Completed
• Trial end date: 2016-06-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eva Szigethy; University of Pittsburgh
• Collaborator: Crohn's and Colitis Foundation
• Treatments: Bupropion

Criteria

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)