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

NCT05956158 · Dartmouth-Hitchcock Medical Center

Recruiting

In plain English

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About this study

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.

Eligibility criteria

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

Study design

Enrollment target: 83 participants

Allocation: randomized

Masking: triple

Age groups: adult, older_adult

Timeline

Starts: 2023-11-28

Estimated completion: 2026-11-30

Last updated: 2025-10-31

Interventions

Behavioral: Behavioral TreatmentBehavioral: Sleep Education Treatment

Primary outcomes

• Feasibility of the intervention as measured by attrition rate over time (Baseline, 8 weeks, 21 weeks, and 34 weeks)
• Feasibility of the intervention as measured by recruitment rate over time (From study initiation until we are no longer actively recruiting (approximately 24 months))
• Feasibility of the intervention as measured by assessment completion at multiple time points (Baseline, 8 weeks, 21 weeks, and 34 weeks)

Sponsor

Dartmouth-Hitchcock Medical Center · other

All locations (1)

Dartmouth-Hitchcock Medical CenterRecruiting

Lebanon, New Hampshire, United States

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