Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

• ClinicalTrials.gov Identifier: NCT02162862
• Recruitment Status: Completed
• First Posted: June 13, 2014
• Results First Posted: September 13, 2017
• Last Update Posted: September 13, 2017
• Sponsor: Eva Szigethy
• Collaborator: Crohn's and Colitis Foundation
• Information provided by (Responsible Party): Eva Szigethy, University of Pittsburgh

Tracking Information

• First Submitted Date: June 11, 2014
• First Posted Date: June 13, 2014
• Results First Submitted Date: June 28, 2017
• Results First Posted Date: September 13, 2017
• Last Update Posted Date: September 13, 2017
• Actual Study Start Date: July 2013
• Actual Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2017)

• 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.

Original Primary Outcome Measures (submitted: June 11, 2014)

• Change from baseline in Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline (week 0) to end of study (week 14) ]
  MFI score range is 0-100. Higher score indicates higher level of fatigue.
• Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline (week 0) to end of study (week 14) ]
  ESS scoring range from 0-24 with higher score indicating increased likelihood for sleepiness or dozing.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: June 11, 2014)

Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline (week 0) to end of study (week 14) ]

PSQI score range is 0-21 with higher score indicating greater sleep disturbance.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sleep Disturbance
• Fatigue
• Inflammatory Bowel Disease

Intervention

• Behavioral: Behavioral Counseling
• Drug: bupropion-SR
  Other Name: Wellbutrin

Study Arms

• Behavioral Counseling
  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.
  Intervention: 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.
  Interventions:

  • Behavioral: Behavioral Counseling
  • Drug: bupropion-SR
• No Intervention: Healthy Control
  The healthy control group includes individuals who are free of physical and psychiatric illness between the ages of 15-30.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2017): 99
• Original Estimated Enrollment (submitted: June 11, 2014): 100
• Actual Study Completion Date: June 30, 2016
• Actual Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 30 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02162862
• Other Study ID Numbers: CCFA 13050045
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Eva Szigethy, University of Pittsburgh
• Study Sponsor: Eva Szigethy
• Collaborators: Crohn's and Colitis Foundation

Investigators

• Principal Investigator: Eva Szigethy, MD, PhD; University of Pittsburgh

• PRS Account: University of Pittsburgh
• Verification Date: June 2017