20 Participants NeededMy employer runs this trial

Cognitive Behavioral Therapy for Insomnia

(RISE-UC Trial)

JK
Overseen ByJessica K Salwen-Deremer, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dartmouth-Hitchcock Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I currently have active ulcerative colitis.
* Access to internet or cell phone service sufficient for telehealth
I have trouble sleeping, with significant insomnia symptoms.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis over 7-8 weeks

7-8 weeks
5 telehealth visits, 5-10 minute phone calls between visits

Follow-up

Participants are monitored for changes in insomnia symptoms and sleep continuity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CBT-I

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CBT-I UC TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+