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

Dartmouth Health

Status: Completed

Conditions: Inflammation; Insomnia; Sleep Disturbance; Pain; Crohn Disease

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT05034159

STUDY02001191

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Cognitive Behavioral Therapy for Insomnia

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia

Waitlist

No Intervention group

Description:

No intervention for 8 weeks.