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

Study Overview
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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.

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.

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

Conditions
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Insomnia, Crohn Disease

Intervention / Treatment
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* Behavioral: Behavioral Treatment
* Behavioral: Sleep Education Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate CD based on PRO-3 & objective data 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 smoker (tobacco, nicotine) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Treatment<br> | Behavioral: Behavioral Treatment<br>* This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.<br>* Other names: CBT-I;|
| Placebo Comparator: Sleep Education Treatment<br> | Behavioral: Sleep Education Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention as measured by attrition rate over time | Attrition rate will be based on the percentage of participants who have dropped out of the trial at different time points. | Baseline, 8 weeks, 21 weeks, and 34 weeks | 
| Feasibility of the intervention as measured by recruitment rate over time | Recruitment rate will be based on the number of participants who are recruited into the trial per month. | 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 | Assessment completion rate will be based on the percentage of participants who complete all the required questionnaires and tasks at each time point. | Baseline, 8 weeks, 21 weeks, and 34 weeks | 
| Feasibility of the intervention as measured by qualitative interviews | Feasibility will be based on interview-derived themes related to barriers and facilitators to study engagement. Data will be collected at two time points to ensure completeness of themes. | 8 weeks and 34 weeks | 
| Acceptability of the intervention as measured by visit completion | Visit completion will be based the number of visits (out of 5) completed by each participant. | 8 weeks | 
| Treatment acceptability questionnaire score | The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability. | 1 week | 
| Acceptability of the intervention as measured by qualitative interviews | Acceptability will be based on interview-derived themes related to aspects of the intervention that participants found helpful and unhelpful. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insomnia symptoms as measured by the Insomnia Severity Index | The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms. | Baseline, 8 weeks, 21 weeks, and 34 weeks | 
| Change in diary-based sleep onset latency | A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary | Baseline, 8 weeks, 21 weeks, and 34 weeks | 
| Change in diary-based wake after sleep onset | A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary | Baseline, 8 weeks, 21 weeks, and 34 weeks | 
| Change in Crohn's disease symptoms as measured by the Patient Reported Outcomes 3 | The Patient Reported Outcomes 3 (PRO-3) is a self-report questionnaire designed to measure the severity of Crohn's disease symptoms in the past week. The PRO-3 is made up of 3 items (stool frequency, pain, and well-being) and higher scores are indicative of more severe symptoms. Scores are interpreted as follows: <13=quiescent or inactive disease; 13-21=mildly active disease; 22-52=moderately active disease; 53 and up=severely active disease. | Baseline, 8 weeks, 21 weeks, and 34 weeks |