CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Trial of CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease

Conditions
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Crohn Disease, Insomnia, Sleep Disturbance, Pain, Inflammation

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy for Insomnia<br>CBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT. This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session. Five CBT-I sessions will be delivered over the course of 8 weeks. Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping. Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing. | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* Same as is described previously.<br>|
| No Intervention: Waitlist<br>No intervention for 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insomnia symptoms as measured by the Insomnia Severity Index | 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. | From baseline assessment to 1-month post intervention | 
| Change in diary-based sleep onset latency | A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary | From baseline assessment to 1-month post intervention | 
| Change in diary-based wake after sleep onset | A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary | From baseline assessment to 1-month post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep efficiency based on diary | Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary | From baseline assessment to 1-month post intervention | 
| Change in sleep efficiency based on actigraphy | Change in sleep efficiency (total sleep time / time in bed) as measured by actigraphy (actigraph) | From baseline assessment to 1-month post intervention | 
| Change in diary sleep efficiency based on ambulatory EEG monitoring | Change in sleep efficiency (total sleep time / time in bed) as measured by ambulatory EEG sleep architecture monitoring (sleep profiler) | From baseline assessment to 1-month post intervention | 
| Change in sleep onset latency as measured by actigraphy | Change in sleep onset latency as measured by actigraphy (actigraph) | From baseline assessment to 1-month post intervention | 
| Change in wake after sleep onset as measured by actigraphy | Change in wake after sleep onset as measured by actigraphy (actigraph) | From baseline assessment to 1-month post intervention | 
| Change in sleep onset latency as measured by ambulatory EEG monitoring | Change in sleep onset latency as measured by ambulatory EEG sleep architecture monitoring (sleep profiler) | From baseline assessment to 1-month post intervention | 
| Change in wake after sleep onset as measured by ambulatory EEG monitoring | Change in wake after sleep onset as measured by ambulatory EEG sleep architecture monitoring (sleep profiler) | From baseline assessment to 1-month post intervention | 
| Change in self-reported pain as measured by the Brief Pain Inventory | 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. | From baseline assessment to 1-month post intervention | 
| Change in behaviorally assessed pain tolerance via the Cold Pressor Test | 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. | From baseline assessment to 1-month post intervention | 
| Change in self-reported Crohn's disease symptoms as measured by the Patient Reported Outcomes-3 | 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. | From baseline assessment to 1-month post intervention | 
| Change in time spent in slow wave sleep | 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 | From baseline assessment to 1-month post intervention | 
| Change in C-reactive protein | We will measure blood levels of C-reactive protein | From baseline assessment to 1-month post intervention | 
| Change in fecal calprotectin | We will measure levels of fecal calprotectin via a stool sample. | From baseline assessment to 1-month post intervention |