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

September 9, 2026 updated by: Jessica.K.Salwen-Deremer, Dartmouth-Hitchcock Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention as measured by attrition rate over time
Time Frame: Baseline, 8 weeks, 21 weeks, and 34 weeks
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
Time Frame: From study initiation until we are no longer actively recruiting (approximately 24 months)
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
Time Frame: Baseline, 8 weeks, 21 weeks, and 34 weeks
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
Time Frame: 8 weeks and 34 weeks
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
Time Frame: 8 weeks
Visit completion will be based the number of visits (out of 5) completed by each participant.
8 weeks
Treatment acceptability questionnaire score
Time Frame: 1 week
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
Time Frame: 8 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in insomnia symptoms as measured by the Insomnia Severity Index
Time Frame: Baseline, 8 weeks, 21 weeks, and 34 weeks
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
Time Frame: Baseline, 8 weeks, 21 weeks, and 34 weeks
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
Time Frame: Baseline, 8 weeks, 21 weeks, and 34 weeks
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
Time Frame: Baseline, 8 weeks, 21 weeks, and 34 weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in C-reactive protein
Time Frame: Baseline, 8 weeks, and 21 weeks
We will measure blood levels of C-reactive protein
Baseline, 8 weeks, and 21 weeks
Change in fecal calprotectin
Time Frame: Baseline, 8 weeks, and 21 weeks
We will measure levels of fecal calprotectin via a stool sample.
Baseline, 8 weeks, and 21 weeks
Change in sleep architecture
Time Frame: Baseline, 8 weeks, and 21 weeks
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
Time Frame: Baseline, 8 weeks, and 21 weeks
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
Time Frame: Baseline, 8 weeks, 21 weeks, and 34 weeks
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
Time Frame: Baseline, 8 weeks, and 21 weeks
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
Time Frame: Baseline, 8 weeks, and 21 weeks
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
Time Frame: Baseline, 8 weeks, and 21 weeks
Change in sleep efficiency (total sleep time / time in bed), derived from the Oura ring.
Baseline, 8 weeks, and 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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