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Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Eva Szigethy, University of Pittsburgh

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).

Condition or disease Intervention/treatment Phase
Sleep Disturbance Fatigue Inflammatory Bowel Disease Behavioral: Behavioral Counseling Drug: bupropion-SR Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease: A Novel Adjunctive Therapy for Chronic Inflammatory Illness
Actual Study Start Date : July 2013
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
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
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 Name: 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.



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162862


Locations
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United States, Pennsylvania
Presbyterian University Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Eva Szigethy
Crohn's and Colitis Foundation
Investigators
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Principal Investigator: Eva Szigethy, MD, PhD University of Pittsburgh

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Responsible Party: Eva Szigethy, Associate Professor of Psychiatry, Pediatrics, and Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02162862    
Other Study ID Numbers: CCFA 13050045
First Posted: June 13, 2014    Key Record Dates
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eva Szigethy, University of Pittsburgh:
Inflammatory Bowel Disease
Physical Illness
Wellbutrin
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Dyssomnias
Sleep Wake Disorders
Parasomnias
Fatigue
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors