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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)
Awards & highlights
RISE Trial 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.Check my eligibility
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.See study design
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.
RISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study initiation until we are no longer actively recruiting (approximately 24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study initiation until we are no longer actively recruiting (approximately 24 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreOther outcome measures
Change in C-reactive protein
Change in behaviorally assessed pain tolerance via the Cold Pressor Test
Change in diary-based sleep efficiency
+5 moreRISE 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
~190
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,256 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with restless leg syndrome.I am currently using opioids for pain management.I have an ileostomy or colostomy.I have been diagnosed with a seizure disorder.I am currently taking corticosteroids.I have been diagnosed with sleep apnea.My sleep and CD medications have been stable for 3 months.I have trouble sleeping and it takes me over 30 minutes to fall asleep or stay asleep.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Treatment
- Group 2: Sleep Education Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this medical experiment opened its doors to enrollees yet?
"The clinicaltrial.gov portal indicates that this medical trial has concluded its recruitment phase and is no longer looking for participants. Although it was initially posted on July 26th 2023, the last edit made to the study's page was dated July 13th 2023. Fortunately, there are currently 488 other studies that are actively seeking volunteers to join their research efforts."
Answered by AI
What are the main goals of this experiment?
"In order to ascertain the efficacy of the intervention, investigators will monitor primary outcome measures such as recruitment rate over a span of Baseline, 8 weeks, 21 weeks and 34 week. Further assessments include changes in sleep onset latency (a weekly average derived from self-reported diaries) wake after sleep onset (again taken from diary entries). Lastly, Crohn's disease symptom severity is evaluated via Patient Reported Outcomes 3 which runs on a score system ranging from <13 indicating quiescent or inactive disease to 53+ representing severely active condition."
Answered by AI
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