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

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).

Study Overview

• Status: Completed
• Conditions: Fatigue; Sleep Disturbance; Inflammatory Bowel Disease
• Intervention / Treatment: Behavioral: Behavioral Counseling; Drug: bupropion-SR

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
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15213
      • Presbyterian University Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: Behavioral Counseling
Other: 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.	Behavioral: Behavioral Counseling; Drug: bupropion-SR; Other Names: Wellbutrin
No Intervention: Healthy Control; The healthy control group includes individuals who are free of physical and psychiatric illness between the ages of 15-30.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm	MFI score range is 0-100. Higher score indicates higher level of fatigue.	Baseline (week 0) to end of study (week 14)
Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm	PSQI score range is 0-21 with higher score indicating greater sleep disturbance.	Baseline (week 0) to end of study (week 14)

Collaborators and Investigators

• Sponsor: Eva Szigethy
• Collaborators: Crohn's and Colitis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; Wellbutrin; Physical Illness
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Nervous System Diseases; Sleep Wake Disorders; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Dyssomnias; Parasomnias; Intestinal Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: CCFA 13050045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO