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

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

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 Overview

• Status: Completed
• Conditions: Pain; Inflammation; Insomnia; Sleep Disturbance; Crohn Disease
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy for Insomnia; 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; Same as is described previously.
No Intervention: Waitlist; No intervention for 8 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Crohn's and Colitis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Sleep Wake Disorders; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Inflammation; Dyssomnias; Parasomnias; Crohn Disease
• Other Study ID Numbers: STUDY02001191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No