A Phase 4 interventional study of Behavioral Counseling and bupropion-SR in Sleep Disturbance, Fatigue and Inflammatory Bowel Disease, sponsored by Eva Szigethy. Completed at 2 sites in United States. Open to participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by Eva Szigethy · Phase 4, Interventional, and Treatment
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).
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.
962 studies on the registry are indexed under Intestinal Diseases; 173 are open to participants now.
This study's enrollment of 99 is above the median of 70 across 551 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Eva Szigethy is the lead sponsor of 2 studies on the registry; none are open to participants now.
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IBD Group:
Healthy Volunteer Group:
Exclusion Criteria:
IBD Group:
Healthy Volunteer Group:
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
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
The healthy control group includes individuals who are free of physical and psychiatric illness between the ages of 15-30.
Also known as: Wellbutrin
Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm
MFI score range is 0-100. Higher score indicates higher level of fatigue.
Time frame: 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.
Time frame: Baseline (week 0) to end of study (week 14)
Recruitment took place at the Digestive Disorders Clinic at Presbyterian Hospital in Pittsburgh, PA. Recruitment began 11/13/13 and ended 2/18/16.
| Milestone | Healthy Control | Behavioral Counseling | Behavioral Counseling + Bupropion |
|---|---|---|---|
| Started | 31 | 35 | 33 |
| Completed | 31 | 24 | 29 |
| Not completed | 0 | 11 | 4 |
| Withdrew: Lost to follow-up | 0 | 11 | 0 |
| Withdrew: Subject did not feel the med was needed | 0 | 0 | 4 |
MFI score range is 0-100. Higher score indicates higher level of fatigue.
| units on a scale | Behavioral Counseling | Healthy Control | Behavioral Counseling + Bupropion |
|---|---|---|---|
| Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm | 18.727 ± 13.843 | -1.828 ± 5.8 | 16.367 ± 13.962 |
PSQI score range is 0-21 with higher score indicating greater sleep disturbance.
| units on a scale | Behavioral Counseling | Healthy Control | Behavioral Counseling + Bupropion |
|---|---|---|---|
| Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm | 4.857 ± 3.928 | -.154 ± 1.69 | 6.571 ± 3.696 |
Collected over The study was conducted over a period of 2 years. Each subject participated in the study for 4 months. No adverse events were reported for any subjects during their time in the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Control | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Behavioral Counseling | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Behavioral Counseling + Bupropion | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Categorical(Participants) | Behavioral Counseling | Control Group | Behavioral Counseling + Bupropion | Total |
|---|---|---|---|---|
| <=18 years | 4 | 6 | 5 | 15 |
| Between 18 and 65 years | 31 | 25 | 28 | 84 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Behavioral Counseling | Control Group | Behavioral Counseling + Bupropion | Total |
|---|---|---|---|---|
| Mean | 23.7 ± 4.7 | 23.5 ± 4.3 | 23.96 ± 5.76 | 23.7 ± 4.7 |
| Sex: Female, Male(Participants) | Behavioral Counseling | Control Group | Behavioral Counseling + Bupropion | Total |
|---|---|---|---|---|
| Female | 22 | 19 | 19 | 60 |
| Male | 13 | 12 | 14 | 39 |
| Region of Enrollment(participants) | Behavioral Counseling | Control Group | Behavioral Counseling + Bupropion | Total |
|---|---|---|---|---|
| United States | 35 | 31 | 33 | 99 |
Plan to share: No
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Eva Szigethy