RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-28

Study Completion:2026-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05956158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-28

Study Completion Date2026-10-01

Study Record Updates

Study Start Date2023-11-28

Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

Insomnia
Crohn Disease