InsomniaRISE-UCNCT07428629
Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
A study testing CBT-I UC in people with Insomnia and Ulcerative Colitis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Ulcerative Colitis
- What is being tested?
- CBT-I UC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to 1 Dec 2026
- 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
- Active UC based on PRUCSI
- Insomnia Severity Index score > 8 and SOL or WASO > 30 minutes
- Stability of sleep \& UC 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 13Show fewer
- Current pregnancy or nursing
- Ileostomy or colostomy
- Diagnosis of seizure disorder
- Diagnosis of sleep apnea
- Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
- Night shift, rotating shift work, or frequent travel outside of time zone
- Residence in a state where we cannot conduct telehealth visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Jessica Salwen-Deremer, PhD, 603-650-6388, jessica.k.salwen-deremer@hitchcock.org
About this study
The goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. The main questions it aims to answer are:
- Is telehealth-based CBT-I adapted for UC feasible and acceptable to participants?
- Does CBT-I for UC impact insomnia severity and sleep continuity?
Participants will:
- Answer questionnaires online before and after treatment
- Complete an online daily sleep diary before, during, and after treatment
- Participate in 5 telehealth treatment visits over 7-8 weeks
- Participate in 5-10-minute phone calls between treatment visits
- Conditions
- Insomnia, Ulcerative Colitis
- Being tested
- CBT-I UC
- Keywords
- telehealth
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-I UCBehavioural
This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I UC Treatment | Experimental | All participants entered into the study will receive telehealth CBT-I for UC. Receives: Behavioral: CBT-I UC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Measured based on the percentage of participants who complete the full study.
Measured: Baseline, 8 weeks
Recruitment rate
Recruitment rate will be based on the average number of participants who are enrolled into the trial per month.
Measured: From study initiation until we are no longer actively recruiting (approximately 3 months)
Acceptability
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
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
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
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
Change in diary-based sleep efficiency
Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start17 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07428629
- Sponsor's protocol ID
- STUDY02003289
- Acronym
- RISE-UC
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07428629
- Acronym / sponsor ID
- RISE-UC / STUDY02003289
- Conditions
- Insomnia, Ulcerative Colitis
- Keywords
- telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (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 goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. The main questions it aims to answer are:
- Is telehealth-based CBT-I adapted for UC feasible and acceptable to participants?
- Does CBT-I for UC impact insomnia severity and sleep continuity?
Participants will:
- Answer questionnaires online before and after treatment
- Complete an online daily sleep diary before, during, and after treatment
- Participate in 5 telehealth treatment visits over 7-8 weeks
- Participate in 5-10-minute phone calls between treatment visits
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal
| Arm | Type | Receives |
|---|---|---|
| CBT-I UC Treatment | Experimental | Behavioral: CBT-I UCAll participants entered into the study will receive telehealth CBT-I for UC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active UC based on PRUCSI
- Insomnia Severity Index score > 8 and SOL or WASO > 30 minutes
- Stability of sleep \& UC meds for > 3 months
- Access to internet or cell phone service sufficient for telehealth
Key exclusion criteria (13 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 |
|---|---|---|
| CBT-I UCThis treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia. | Behavioural | CBT-I UC Treatment |
Primary outcome
Retention
Time frame: Baseline, 8 weeks
Measured based on the percentage of participants who complete the full study.
Recruitment rate
Time frame: From study initiation until we are no longer actively recruiting (approximately 3 months)
Recruitment rate will be based on the average number of participants who are enrolled into the trial per month.
Acceptability
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.
4 secondary outcomes
Change in insomnia symptoms as measured by the Insomnia Severity Index
Time frame: Baseline, 8 weeks
Change in diary-based sleep onset latency
Time frame: Baseline, 8 weeks
Change in diary-based wake after sleep onset
Time frame: Baseline, 8 weeks
Change in diary-based sleep efficiency
Time frame: Baseline, 8 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 28 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I UC in people with Insomnia and Ulcerative Colitis, 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 13 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: looking for participants now, as of the sponsor's last update on 28 Aug 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. 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?
Contact Jessica K Salwen-Deremer, PhD ((603) 650-5261, jessica.k.salwen-deremer@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: Baseline, 8 weeks). The study lists 4 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 28 Aug 2026.