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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Crohn Disease
• Intervention / Treatment: Behavioral: Behavioral Treatment; Behavioral: Sleep Education Treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Contact: Jessica K Salwen-Deremer, PhD; Phone Number: 603-650-6388; Email: jessica.k.salwen-deremer@hitchcock.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Treatment	Behavioral: Behavioral Treatment; This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.; Other Names: CBT-I; Cognitive Behavioral Therapy for Insomnia
Placebo Comparator: Sleep Education Treatment	Behavioral: Sleep Education Treatment; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C-reactive protein	We will measure blood levels of C-reactive protein	Baseline, 8 weeks, and 21 weeks
Change in fecal calprotectin	We will measure levels of fecal calprotectin via a stool sample.	Baseline, 8 weeks, and 21 weeks
Change in sleep architecture	We will measure changes in percent time spent in light sleep, deep sleep, and rapid eye movement (REM) sleep using the Oura ring.	Baseline, 8 weeks, and 21 weeks
Change in behaviorally assessed pain tolerance via the Cold Pressor Test	The Cold Pressor Test involves submerging one's non-dominant hand in ice water and rating discomfort at regular, pre-determined intervals. Pain tolerance will be measured based on the total amount of time a participant can keep their hand submerged, with a maximum of 3 minutes.	Baseline, 8 weeks, and 21 weeks
Change in diary-based sleep efficiency	Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary.	Baseline, 8 weeks, 21 weeks, and 34 weeks
Change in objective sleep onset latency	Change in the time it takes to fall asleep each night, derived from the Oura ring.	Baseline, 8 weeks, and 21 weeks
Change in objective wake after sleep onset	Change in the time spent awake in the middle of the night, derived from the Oura ring.	Baseline, 8 weeks, and 21 weeks
Change in objective sleep efficiency	Change in sleep efficiency (total sleep time / time in bed), derived from the Oura ring.	Baseline, 8 weeks, and 21 weeks

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Sleep Initiation and Maintenance Disorders; Crohn Disease
• Other Study ID Numbers: STUDY02001855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No