Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

NCT ID: NCT02162862

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Sleep Disturbance; Fatigue; Inflammatory Bowel Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Behavioral Counseling

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

Behavioral Counseling

Intervention Type: BEHAVIORAL

bupropion-SR

Intervention Type: DRUG

Healthy Control

The healthy control group includes individuals who are free of physical and psychiatric illness between the ages of 15-30.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioral Counseling

Intervention Type: BEHAVIORAL

bupropion-SR

Intervention Type: DRUG

Other Intervention Names

Wellbutrin

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:

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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crohn's and Colitis Foundation

OTHER

Sponsor Role: collaborator

Eva Szigethy

OTHER

Sponsor Role: lead

Responsible Party

Eva Szigethy

Associate Professor of Psychiatry, Pediatrics, and Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eva Szigethy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Presbyterian University Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

CCFA 13050045

Identifier Type: -

Identifier Source: org_study_id