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

Pain Clinical Trial

— SPIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034159
• Other study ID #: STUDY02001191
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: April 19, 2023

Study information

• Verified date: May 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Dyssomnias
• Inflammation
• Insomnia
• Pain
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
Same as is described previously.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in C-reactive protein	We will measure blood levels of C-reactive protein	From baseline assessment to 1-month post intervention
Secondary	Change in fecal calprotectin	We will measure levels of fecal calprotectin via a stool sample.	From baseline assessment to 1-month post intervention