Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

NCT02162862 | Completed Phase 4 Results DMC

• 1 other identifier: CCFA 13050045
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

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).

Conditions

Sleep Disturbance; Fatigue; Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease; Physical Illness; Wellbutrin

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

Behavioral Counseling

OTHER

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

OTHER

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

Healthy Control

NO INTERVENTION

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

Interventions

Behavioral Counseling BEHAVIORAL

Behavioral Counseling; Behavioral counseling + bupropion-SR

bupropion-SR DRUG

Also known as: Wellbutrin

Behavioral counseling + bupropion-SR

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• IBD Group:
• Biopsy confirmed Crohn's Disease
• Qualifying scores on Multidimensional Fatigue Inventory and Pittsburgh Sleep Quality Index
• Healthy Volunteer Group:

You may not qualify if:

• 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

Sponsors & Collaborators

• Eva Szigethy: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (2)

Presbyterian University Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Parasomnias; Fatigue; Inflammatory Bowel Diseases

Interventions

Behavior Therapy; Bupropion

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Propiophenones; Ketones; Organic Chemicals

Limitations and Caveats

There were no limitations to this study.

Results Point of Contact

• Title: Dr. Eva Szigethy
• Organization: University of Pittsburgh Medical Center

szigethye@upmc.edu

412-802-6696

Study Officials

• Eva Szigethy, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Pediatrics, and Medicine

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: July 1, 2013
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: September 13, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)