Clinical trial NCT05034159: CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease
Official title: A Pilot Trial of CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Insomnia
Sleep Disturbance
Pain
Inflammation
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2021-09-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in insomnia symptoms as measured by the Insomnia Severity Index
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in diary-based sleep onset latency
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in diary-based wake after sleep onset
timeFrame: From baseline assessment to 1-month post intervention
Secondary outcomes:
measure: Change in sleep efficiency based on diary
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in sleep efficiency based on actigraphy
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in diary sleep efficiency based on ambulatory EEG monitoring
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in sleep onset latency as measured by actigraphy
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in wake after sleep onset as measured by actigraphy
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in sleep onset latency as measured by ambulatory EEG monitoring
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in wake after sleep onset as measured by ambulatory EEG monitoring
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in self-reported pain as measured by the Brief Pain Inventory
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in behaviorally assessed pain tolerance via the Cold Pressor Test
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in self-reported Crohn's disease symptoms as measured by the Patient Reported Outcomes-3
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in time spent in slow wave sleep
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in C-reactive protein
timeFrame: From baseline assessment to 1-month post intervention
measure: Change in fecal calprotectin
timeFrame: From baseline assessment to 1-month post intervention
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: