Insomnia · Ulcerative Colitis
Telehealth Insomnia Therapy for Adults With Ulcerative Colitis
This pilot study is examining whether ulcerative colitis-adapted cognitive behavioral therapy for insomnia is feasible, acceptable, and associated with changes in sleep among adults with ulcerative colitis and insomnia.
Registry title: Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- CBT-I UC
- Design
- Not provided
- Central study contact
- Jessica K Salwen-Deremer, PhD(603) 650-5261jessica.k.salwen-deremer@hitchcock.org
- Sponsor
- Dartmouth-Hitchcock Medical Center
Research question
Is telehealth cognitive behavioral therapy for insomnia adapted for ulcerative colitis feasible and acceptable, and how does it affect insomnia severity and continuity of sleep?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with active ulcerative colitis.
- The study is looking for people with an Insomnia Severity Index score above 8 and more than 30 minutes to fall asleep or awake after initially falling asleep.
- The study is looking for people whose sleep and ulcerative colitis medications have been stable for more than three months.
- The study is looking for people with internet access or cell-phone service sufficient for telehealth.
- Participants must live in a state where the research team can conduct telehealth visits.
Participation overview
What participation may involve
Participants receive telehealth CBT-I UC and complete online questionnaires, daily sleep diaries, five treatment visits, and brief phone calls between visits. What participation may involve: - Receive ulcerative colitis-adapted cognitive behavioral therapy for insomnia through telehealth. - Answer online questionnaires before and after treatment. - Complete an online daily sleep diary before, during, and after treatment. - Attend five telehealth treatment visits. - Participate in phone calls lasting 5 to 10 minutes between treatment visits. The five telehealth treatment visits take place over 7 to 8 weeks. The registry reports five telehealth treatment visits plus brief phone calls between treatment visits.
Study interventions
What participants may receive or do
- CBT-I UC: All participants receive telehealth cognitive behavioral therapy for insomnia adapted for ulcerative colitis, designed to change patterns of behavior and thought that contribute to insomnia.
Study design
How the comparison works
This is an interventional pilot study with one treatment group. The registry estimates enrollment of 20 participants, all of whom receive the telehealth behavioral treatment. The study is not described as randomized; allocation is listed as not applicable because there is one treatment group. There is no masking, meaning participants and study personnel are not described as blinded to the treatment. The registry lists only one experimental group and does not describe a separate comparison or control group. No placebo or sham intervention is listed; all enrolled participants are assigned to receive CBT-I UC.
Reported activities
Procedures and tests
- Online questionnaires are completed before and after treatment.
- An online daily sleep diary records sleep before, during, and after treatment.
- The Insomnia Severity Index, a seven-item questionnaire, measures insomnia symptoms and related impairment.
- Sleep-diary information is used to assess time needed to fall asleep, time awake after sleep begins, and sleep efficiency.
- A four-item Treatment Acceptability Questionnaire assesses participants' views of the intervention.
- Study staff track treatment-visit completion and whether participants complete the full study.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be age 18 or older.
- Participants must have active ulcerative colitis as assessed using PRUCSI.
- Participants must have an Insomnia Severity Index score above 8 and either sleep-onset latency or wake-after-sleep-onset longer than 30 minutes.
- Sleep and ulcerative colitis medications must have been stable for more than three months.
- Participants need internet access or cell-phone service sufficient for telehealth.
Possible reasons someone may not be able to join
- A Patient Health Questionnaire-9 depression score above 15 excludes participation.
- A Generalized Anxiety Disorder-7 anxiety score above 15 excludes participation.
- An unstable major psychiatric condition, such as bipolar disorder or a psychotic disorder, excludes participation.
- Current alcohol or substance abuse excludes participation.
- Current opioid use for pain control excludes participation.
- Current systemic corticosteroid use excludes participation.
- People who are currently pregnant or nursing are excluded.
- Having an ileostomy or colostomy excludes participation.
- A diagnosis of sleep apnea excludes participation.
- Restless legs syndrome or a positive Cambridge-Hopkins RSLq screen excludes participation.
- Night-shift work, rotating-shift work, or frequent travel outside the participant's time zone excludes participation.
- Residence in a state where the team cannot conduct telehealth visits excludes participation.
Important unknowns
What the record does not make clear
- The registry reports five telehealth visits and brief calls between visits but does not give the timing of each visit or the number of calls.
- Sleep and ulcerative colitis medications must be stable for more than three months, but the registry does not say whether all current medications continue unchanged during the study.
- The registry does not describe any medication washout requirement.
- The registry does not explain how worsening insomnia or ulcerative colitis symptoms would be managed during the study.
- The registry does not state whether endoscopy or other ulcerative colitis testing is required.
- The registry does not describe study-related costs or insurance billing.
- The registry does not state whether participants are compensated.
- Treatment is delivered by telehealth, but the registry does not identify all states in which the research team may conduct visits.
- The registry does not describe access to CBT-I UC after study participation ends.
Before contacting the site
Questions for the study team
- What is the timing and expected length of each telehealth visit, and how many between-visit calls are planned?
- How do you assess active ulcerative colitis using PRUCSI, and does that assessment require recent tests or records?
- Which current sleep and ulcerative colitis medications may continue, and what happens if treatment must change during the study?
- Are endoscopy, laboratory testing, stool testing, or other medical procedures required?
- What support is provided if insomnia or ulcerative colitis symptoms worsen during the study?
- Which states are eligible for telehealth participation?
- Are there participant costs, insurance charges, or compensation?
Before changing care
Questions for your gastroenterologist
- Is my ulcerative colitis currently stable enough to consider a behavioral insomnia study?
- Could participation interfere with my current ulcerative colitis treatment plan or any medication changes I may need?
- What approved options are available for my insomnia, and how do they compare with considering this study?
- Are there clinical concerns specific to my ulcerative colitis, sleep condition, or other health conditions that I should discuss with the research team?
- How should my gastroenterology team and the research team coordinate if my ulcerative colitis symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
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
Study design and administration
- Organization
- Dartmouth-Hitchcock Medical Center
- Organization class
- Other
- Organization study ID
- STUDY02003289
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
CBT-I UC Treatment
All participants entered into the study will receive telehealth CBT-I for UC.
Interventions: Behavioral: CBT-I UC
Interventions
Behavioral
CBT-I UC
This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (4)
- Active UC based on PRUCSIRegistry-derived · unreviewed
- Insomnia Severity Index score \> 8 and SOL or WASO \> 30 minutesRegistry-derived · unreviewed
- Stability of sleep \& UC meds for \> 3 monthsRegistry-derived · unreviewed
- Access to internet or cell phone service sufficient for telehealthRegistry-derived · unreviewed
Exclusion criteria (13)
- PHQ-9 depression score \> 15Registry-derived · unreviewed
- GAD-7 anxiety score \> 15Registry-derived · unreviewed
- Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)Registry-derived · unreviewed
- Current alcohol or substance abuseRegistry-derived · unreviewed
- Current opioid use for pain controlRegistry-derived · unreviewed
- Current systemic corticosteroid useRegistry-derived · unreviewed
- Current pregnancy or nursingRegistry-derived · unreviewed
- Ileostomy or colostomyRegistry-derived · unreviewed
- Diagnosis of seizure disorderRegistry-derived · unreviewed
- Diagnosis of sleep apneaRegistry-derived · unreviewed
- Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screenRegistry-derived · unreviewed
- Night shift, rotating shift work, or frequent travel outside of time zoneRegistry-derived · unreviewed
- Residence in a state where we cannot conduct telehealth visitsRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Retention
Time frame: Baseline, 8 weeks
Measured based on the percentage of participants who complete the full study.
Primary outcome
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.
Primary outcome
Acceptability
Time frame: 8 weeks
Visit completion will be based the number of visits (out of 5) completed by each participant.
Primary outcome
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.
Secondary outcome
Change in insomnia symptoms as measured by the Insomnia Severity Index
Time frame: Baseline, 8 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.
Secondary outcome
Change in diary-based sleep onset latency
Time frame: Baseline, 8 weeks
A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary
Secondary outcome
Change in diary-based wake after sleep onset
Time frame: Baseline, 8 weeks
A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary
Secondary outcome
Change in diary-based sleep efficiency
Time frame: Baseline, 8 weeks
Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary.
Recruiting locations in the United States
Dartmouth-Hitchcock Medical Center
RecruitingLebanon, New Hampshire, 03756, United States
Jessica Salwen-Deremer, PhD603-650-6388jessica.k.salwen-deremer@hitchcock.org
Central study contacts
Registry dates
- First posted
- Feb 24, 2026
- Primary completion
- Jul 1, 2026
- Overall completion
- Sep 1, 2026
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.