Phase 4 Completed N=99 Treatment

Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

Sleep Disturbances · Fatigue · Inflammatory Bowel Disease

Source: ClinicalTrials.gov NCT02162862 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcomePrimary: Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm — 18.727; -1.828; 16.367 units on a scale — p=<0.005

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm	18.727; -1.828; 16.367	<0.005 sig
PRIMARY Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm	4.857; -.154; 6.571	<0.005 sig

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02162862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.