Clinical trial NCT02162862: Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease
Official title: Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease: A Novel Adjunctive Therapy for Chronic Inflammatory Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Disturbance
Fatigue
Inflammatory Bowel Disease
Keywords: Inflammatory Bowel Disease
Physical Illness
Wellbutrin
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2014-06-13
Enrollment: 99
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm
timeFrame: Baseline (week 0) to end of study (week 14)
measure: Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm
timeFrame: Baseline (week 0) to end of study (week 14)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Presbyterian University Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Eva Szigethy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: