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Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Procedures mentioned: Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests talk therapy for insomnia (trouble sleeping) adapted for adults with ulcerative colitis (UC), a disease that causes swelling and sores in the large intestine. It looks at whether the video-based treatment is practical, is acceptable to patients, and improves sleep. Treatment includes 5 telehealth visits over 7–8 weeks, short phone calls, online surveys, and a daily sleep diary.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have active UC based on a UC symptom score called PRUCSI.
  • Have an Insomnia Severity Index score above 8 and take more than 30 minutes to fall asleep or spend more than 30 minutes awake after falling asleep.
  • Have had no changes to sleep and UC medicines for more than 3 months.
  • Have internet or cell phone service that supports telehealth visits.

Who can't join

  • Have a depression score above 15 on the PHQ-9 or an anxiety score above 15 on the GAD-7.
  • Have a major mental health condition that is not stable, such as bipolar disorder or a disorder that affects your sense of reality.
  • Currently misuse alcohol or drugs, use opioid pain medicines, or take corticosteroid medicines that affect the whole body.
  • Are pregnant or breastfeeding.
  • Have an ileostomy or colostomy, a surgical opening in the belly for stool to leave the body.
  • Have a seizure disorder, sleep apnea (breathing pauses during sleep), or restless legs syndrome (an urge to move your legs), or screen positive for restless legs syndrome.
  • Work night shifts or rotating shifts, or often travel across time zones.
  • Live in a state where the study team cannot provide telehealth visits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 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 * 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

Study sites (1)

NH