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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a remote (telehealth) insomnia treatment program called RISE for people with Crohn's disease who also struggle with sleep. Poor sleep is very common in Crohn's disease and can worsen symptoms — this trial tests whether treating insomnia improves overall wellbeing. **You may be eligible if...** - You have mild to moderate Crohn's disease - You have an Insomnia Severity Index score of 8 or higher and trouble falling or staying asleep (30+ minutes of sleep disruption) - Your sleep and Crohn's medications have been stable for at least 3 months - You have access to the internet or sufficient cell phone service for telehealth **You may NOT be eligible if...** - You have significant depression or anxiety (high scores on depression or anxiety screening scales) - You have unstable major psychiatric conditions, such as bipolar disorder or psychosis - You currently use opioids for pain, systemic steroids, or alcohol/drugs - You are pregnant or nursing - You have an ileostomy, colostomy, seizure disorder, sleep apnea, or restless leg syndrome - You work night or rotating shifts, or frequently travel across time zones Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

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NCT05956158


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