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

NCT05034159 | Completed

• 1 other identifier: STUDY02001191
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Insomnia; Sleep Disturbance; Pain; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Change in sleep efficiency based on diary

  From baseline assessment to 1-month post intervention

• Change in sleep efficiency based on actigraphy

  From baseline assessment to 1-month post intervention

• Change in diary sleep efficiency based on ambulatory EEG monitoring

  From baseline assessment to 1-month post intervention

• Change in sleep onset latency as measured by actigraphy

  From baseline assessment to 1-month post intervention

• Change in wake after sleep onset as measured by actigraphy

  From baseline assessment to 1-month post intervention

Study Arms (2)

Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

No intervention for 8 weeks.

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

Same as is described previously.

Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Crohn Disease; Sleep Initiation and Maintenance Disorders; Parasomnias; Pain; Inflammation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 5, 2021
• Study Start: October 22, 2021
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)