Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I UC Treatment | Experimental | All participants entered into the study will receive telehealth CBT-I for UC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I UC | Behavioral | This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Measured based on the percentage of participants who complete the full study. | Baseline, 8 weeks |
| Recruitment rate | Recruitment rate will be based on the average number of participants who are enrolled into the trial per month. | 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. | 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. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica K Salwen-Deremer, PhD | Contact | (603) 650-5261 | jessica.k.salwen-deremer@hitchcock.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Longitudinal
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 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. | Baseline, 8 weeks |
| D001523 |
| Mental Disorders |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |