InsomniaRISENCT05956158
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
A study testing Behavioral Treatment and Sleep Education Treatment in people with Insomnia and Crohn Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Crohn Disease
- What is being tested?
- Behavioral Treatment and Sleep Education Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 26 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the 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.
- Conditions
- Insomnia, Crohn Disease
- Being tested
- Behavioral Treatment, Sleep Education Treatment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentBehavioural
Also called Cognitive Behavioral Therapy for Insomnia, CBT-I
This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.
Sleep Education TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Treatment | Experimental | Not described Receives: Behavioral: Behavioral Treatment |
| Sleep Education Treatment | Placebo comparator | Not described Receives: Behavioral: Sleep Education Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, 8 weeks, 21 weeks, and 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start28 Nov 2023
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica.K.Salwen-Deremer, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956158
- Sponsor's protocol ID
- STUDY02001855
- Acronym
- RISE
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
- ClinicalTrials.gov ID
- NCT05956158
- Acronym / sponsor ID
- RISE / STUDY02001855
- Conditions
- Insomnia, Crohn Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Treatment | Experimental | Behavioral: Behavioral Treatment |
| Sleep Education Treatment | Placebo comparator | Behavioral: Sleep Education Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral TreatmentAlso: Cognitive Behavioral Therapy for Insomnia, CBT-IThis treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia. | Behavioural | Behavioral Treatment |
| Sleep Education TreatmentThis treatment is designed to help participants understand the relationships among sleep, pain, and Crohn's disease and to make changes to insomnia-related behaviors. | Behavioural | Sleep Education Treatment |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Change in insomnia symptoms as measured by the Insomnia Severity Index
Time frame: 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
Change in diary-based wake after sleep onset
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Treatment and Sleep Education Treatment in people with Insomnia and Crohn Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention as measured by attrition rate over time (time frame: Baseline, 8 weeks, 21 weeks, and 34 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.