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

NCT ID: NCT05034159

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-22
• Study Completion Date: 2023-04-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

Same as is described previously.

Waitlist

No intervention for 8 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy for Insomnia

Same as is described previously.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Crohn's and Colitis Foundation

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jessica.K.Salwen-Deremer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

STUDY02001191

Identifier Type: -

Identifier Source: org_study_id