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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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, patients 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 investigators want to understand if they can treat sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. If this study is successful, it will help the investigators understand more about 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

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Insomnia Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Behavioral Treatment

Group Type EXPERIMENTAL

Behavioral Treatment

Intervention Type BEHAVIORAL

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

Sleep Education Treatment

Group Type PLACEBO_COMPARATOR

Sleep Education Treatment

Intervention Type BEHAVIORAL

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.

Interventions

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Behavioral Treatment

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

Intervention Type BEHAVIORAL

Sleep 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Behavioral Therapy for Insomnia CBT-I

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No