Crohn Disease, Inflammation, Insomnia, Pain, Sleep Disturbance
Conditions
Brief summary
People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, people with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the researchers want to understand the treatment of sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. This study will use Cognitive Behavioral Therapy for Insomnia (CBT-I) to treat insomnia symptoms. CBT-I is the recommended treatment for insomnia and has been shown to improve sleep problems, pain, and inflammation in other groups of people. If this study is successful, it will contribute to understanding how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
Same as is described previously.
Sponsors
Crohn's and Colitis Foundation
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Following a baseline assessment, participants are initially randomized to either CBT-I or waitlist. Those in the waitlist condition will repeat their baseline assessment after 8 weeks, then will start CBT-I.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild to moderate Crohn's disease (as assessed by PRO-3 score) * Insomnia severity index score of 8 or greater * Sleep onset latency and/or wake after sleep onset of at least 30 minutes * Access to device and internet/cell phone service sufficient for telehealth
Exclusion criteria
* PHQ-9 score of 20 or greater * GAD-7 score of 20 or greater * Unstable major psychiatric condition * Current alcohol or substance abuse * Current narcotic use for pain control * Current systemic corticosteroid use * Current pregnancy or nursing * Ileostomy or colostomy * Diagnosis of seizure disorder * Diagnosis of sleep apnea or positive STOP-Bang screen * Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RLSq screen * Night shift, rotating shift work, or frequent travel outside of primary time zone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insomnia symptoms as measured by the Insomnia Severity Index | From baseline assessment to 1-month post intervention | The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms. |
| Change in diary-based sleep onset latency | From baseline assessment to 1-month post intervention | A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary |
| Change in diary-based wake after sleep onset | From baseline assessment to 1-month post intervention | A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep onset latency as measured by actigraphy | From baseline assessment to 1-month post intervention | Change in sleep onset latency as measured by actigraphy (actigraph) |
| Change in wake after sleep onset as measured by actigraphy | From baseline assessment to 1-month post intervention | Change in wake after sleep onset as measured by actigraphy (actigraph) |
| Change in sleep onset latency as measured by ambulatory EEG monitoring | From baseline assessment to 1-month post intervention | Change in sleep onset latency as measured by ambulatory EEG sleep architecture monitoring (sleep profiler) |
| Change in wake after sleep onset as measured by ambulatory EEG monitoring | From baseline assessment to 1-month post intervention | Change in wake after sleep onset as measured by ambulatory EEG sleep architecture monitoring (sleep profiler) |
| Change in self-reported pain as measured by the Brief Pain Inventory | From baseline assessment to 1-month post intervention | The Brief Pain Inventory will be used to assess pain location, severity, and interference. Pain severity is rated from 0-10 and pain interference is rated from 0-10; higher scores indicate more severe pain and more pain interference. |
| Change in sleep efficiency based on diary | From baseline assessment to 1-month post intervention | Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary |
| Change in self-reported Crohn's disease symptoms as measured by the Patient Reported Outcomes-3 | From baseline assessment to 1-month post intervention | The Patient Reported Outcomes-3 is a self-report questionnaire that assesses frequency of diarrhea, severity of abdominal pain, and overall well-being. Higher scores indicate more severe Crohn's disease symptoms. |
| Change in time spent in slow wave sleep | From baseline assessment to 1-month post intervention | We will measure percentage of time spent in slow wave sleep during a night's sleep using the Sleep Profiler, an ambulatory EEG sleep monitor |
| Change in C-reactive protein | From baseline assessment to 1-month post intervention | We will measure blood levels of C-reactive protein |
| Change in fecal calprotectin | From baseline assessment to 1-month post intervention | We will measure levels of fecal calprotectin via a stool sample. |
| Change in behaviorally assessed pain tolerance via the Cold Pressor Test | From baseline assessment to 1-month post intervention | The Cold Pressor Test involves submerging one's non-dominant hand in ice water and rating discomfort at regular, pre-determined intervals. Pain tolerance will be measured based on the total amount of time a participant can keep their hand submerged, with a maximum of 2 minutes. |
| Change in sleep efficiency based on actigraphy | From baseline assessment to 1-month post intervention | Change in sleep efficiency (total sleep time / time in bed) as measured by actigraphy (actigraph) |
| Change in diary sleep efficiency based on ambulatory EEG monitoring | From baseline assessment to 1-month post intervention | Change in sleep efficiency (total sleep time / time in bed) as measured by ambulatory EEG sleep architecture monitoring (sleep profiler) |
Countries
United States
Outcome results
None listed