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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Same as is described previously.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
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.
Time frame: 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
Time frame: 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
Time frame: From baseline assessment to 1-month post intervention
Change in sleep efficiency based on diary
Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From baseline assessment to 1-month post intervention
Change in C-reactive protein
We will measure blood levels of C-reactive protein
Time frame: From baseline assessment to 1-month post intervention
Change in fecal calprotectin
We will measure levels of fecal calprotectin via a stool sample.
Time frame: From baseline assessment to 1-month post intervention
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