Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CBT-I UC.
- Who it may be relevant to
- Registry conditions: Insomnia, Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Behavioral CBT-I UC
This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.
Primary outcome measures
- Retention [Time frame: Baseline, 8 weeks]
- Recruitment rate [Time frame: From study initiation until we are no longer actively recruiting (approximately 3 months)]
- Acceptability [Time frame: 8 weeks]
- Treatment acceptability questionnaire score [Time frame: 1 week]
Secondary outcome measures (4)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Dartmouth-Hitchcock Medical Center — Lebanon
Identifiers
NCT: NCT07428629 · STUDY02003289