RecruitingNot ApplicableNCT05956158

RISE: A Remote Study of Insomnia Treatment in Crohn's Disease

Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

83 participants

Start Date

Nov 28, 2023

Study Type

INTERVENTIONAL

Conditions

Insomnia Crohn Disease

Summary

The purpose of this study is to assess whether the investigators can treat insomnia in people with Crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Mild to moderate CD based on PRO-3 \& 50% with objective evidence of active disease
Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes
Stability of sleep \& CD meds for ≥ 3 months
Access to internet or cell phone service sufficient for telehealth

Exclusion Criteria12

PHQ-9 depression score ≥ 15
GAD-7 anxiety score ≥ 15
Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
Current alcohol or substance abuse
Current opioid 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 WatchPAT screen
Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
Night shift, rotating shift work, or frequent travel outside of time zone

Interventions

BEHAVIORALBehavioral Treatment

This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.

BEHAVIORALSleep Education Treatment

This treatment is designed to help participants understand the relationships among sleep, pain, and Crohn's disease and to make changes to insomnia-related behaviors.