Sleep Disturbance, Fatigue, Inflammatory Bowel Disease
Conditions
Keywords
Inflammatory Bowel Disease, Physical Illness, Wellbutrin
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.
Interventions
BEHAVIORALBehavioral Counseling
DRUGbupropion-SR
Sponsors
Crohn's and Colitis Foundation
Eva Szigethy
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm | Baseline (week 0) to end of study (week 14) | MFI score range is 0-100. Higher score indicates higher level of fatigue. |
| Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm | Baseline (week 0) to end of study (week 14) | PSQI score range is 0-21 with higher score indicating greater sleep disturbance. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place at the Digestive Disorders Clinic at Presbyterian Hospital in Pittsburgh, PA. Recruitment began 11/13/13 and ended 2/18/16.
Participants by arm
| Arm | Count |
|---|---|
| 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 Counseling | 35 |
| Control Group Individuals free of physical and psychiatric illness. | 31 |
| Behavioral Counseling + Bupropion 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. | 33 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 11 | 0 |
| Overall Study | Subject did not feel the med was needed | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Total | Behavioral Counseling | Control Group | Behavioral Counseling + Bupropion |
|---|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 4 Participants | 6 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 31 Participants | 25 Participants | 28 Participants |
| Age, Continuous | 23.7 years STANDARD_DEVIATION 4.7 | 23.7 years STANDARD_DEVIATION 4.7 | 23.5 years STANDARD_DEVIATION 4.3 | 23.96 years STANDARD_DEVIATION 5.76 |
| Region of Enrollment United States | 99 participants | 35 participants | 31 participants | 33 participants |
| Sex: Female, Male Female | 60 Participants | 22 Participants | 19 Participants | 19 Participants |
| Sex: Female, Male Male | 39 Participants | 13 Participants | 12 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 35 | 0 / 33 |
| other Total, other adverse events | 0 / 31 | 0 / 35 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 35 | 0 / 33 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Counseling | Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm | 18.727 units on a scale | Standard Deviation 13.843 |
| Healthy Control | Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm | -1.828 units on a scale | Standard Deviation 5.8 |
| Behavioral Counseling + Bupropion | Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm | 16.367 units on a scale | Standard Deviation 13.962 |
p-value: <0.005t-test, 2 sided
p-value: <0.005t-test, 2 sided
p-value: 0.102t-test, 2 sided
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Counseling | Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm | 4.857 units on a scale | Standard Deviation 3.928 |
| Healthy Control | Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm | -.154 units on a scale | Standard Deviation 1.69 |
| Behavioral Counseling + Bupropion | Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm | 6.571 units on a scale | Standard Deviation 3.696 |
p-value: <0.005t-test, 2 sided
p-value: 0.646t-test, 2 sided
p-value: <0.005t-test, 2 sided