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Behavioral Intervention

Insomnia Behavioral Therapy for Crohn's Disease (RISE Trial)

N/A
Recruiting
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study initiation until we are no longer actively recruiting (approximately 24 months)

Summary

This trial studies if treating insomnia can help improve Crohn's symptoms like pain and inflammation.

Who is the study for?
This trial is for people with mild to moderate Crohn's Disease who have insomnia, as shown by certain scores on sleep and health questionnaires. Participants must not be dealing with severe depression or anxiety, substance abuse, major psychiatric conditions, or using opioids. They should not be pregnant, nursing, smoking, taking steroids, or have specific other medical conditions.
What is being tested?
The study is testing if behavioral treatments and sleep education can help improve sleep in those with Crohn's Disease. It will also look at whether better sleep affects pain or inflammation. The treatment will be delivered remotely via telehealth services.
What are the potential side effects?
Since the interventions are non-medical (behavioral and educational), significant side effects are not expected. However, participants may experience changes in mood or stress levels due to changes in their sleeping patterns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study initiation until we are no longer actively recruiting (approximately 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study initiation until we are no longer actively recruiting (approximately 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of the intervention as measured by qualitative interviews
Acceptability of the intervention as measured by visit completion
Feasibility of the intervention as measured by assessment completion at multiple time points
+4 more
Secondary study objectives
Change in Crohn's disease symptoms as measured by the Patient Reported Outcomes 3
Change in diary-based sleep onset latency
Change in diary-based wake after sleep onset
+1 more
Other study objectives
Change in C-reactive protein
Change in behaviorally assessed pain tolerance via the Cold Pressor Test
Change in diary-based sleep efficiency
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Behavioral TreatmentExperimental Treatment1 Intervention
Group II: Sleep Education TreatmentPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Treatment
2019
Completed Phase 4
~670

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
537 Previous Clinical Trials
2,539,633 Total Patients Enrolled

Media Library

Behavioral Treatment (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05956158 — N/A
Crohn's Disease Research Study Groups: Behavioral Treatment, Sleep Education Treatment
Crohn's Disease Clinical Trial 2023: Behavioral Treatment Highlights & Side Effects. Trial Name: NCT05956158 — N/A
Behavioral Treatment (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05956158 — N/A
~47 spots leftby Mar 2026
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