Insomnia, Ulcerative Colitis
Conditions
Keywords
telehealth
Brief 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. 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
BEHAVIORALCBT-I UC
This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Longitudinal
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | Baseline, 8 weeks | Measured based on the percentage of participants who complete the full study. |
| Recruitment rate | 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 | 8 weeks | Visit completion will be based the number of visits (out of 5) completed by each participant. |
| Treatment acceptability questionnaire score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in insomnia symptoms as measured by the Insomnia Severity Index | 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. |
| Change in diary-based sleep onset latency | Baseline, 8 weeks | A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary |
| Change in diary-based wake after sleep onset | 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 |
| Change in diary-based sleep efficiency | Baseline, 8 weeks | Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary. |
Countries
United States
Contacts
CONTACTJessica K Salwen-Deremer, PhD
Outcome results
None listed