Web-based Treatment for Insomnia
(SIESTA-P Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of an online program called Sleep Healthy Using the Internet (SHUTi) in improving sleep and well-being among Black prostate cancer survivors with insomnia. Participants will be randomly assigned to either use SHUTi, which includes six online cognitive behavioral therapy sessions, or access an educational website with general sleep information. The trial aims to determine if SHUTi is feasible, acceptable, and more effective than educational material alone. This trial may suit Black prostate cancer survivors diagnosed in the last five years who have trouble sleeping and have not recently received certain cancer treatments. Participants need a device with internet access or must be willing to attend study appointments. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance sleep health for others in the future.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the Sleep Healthy Using the Internet (SHUTi) program is easy to use. Studies have found that SHUTi can improve sleep quality, make sleep feel more refreshing, and help users fall asleep faster. No major negative side effects have been reported, suggesting that SHUTi is safe for improving sleep across different groups, including older adults. However, individual experiences may vary.12345
Why are researchers excited about this trial?
Researchers are excited about SHUTi because it offers a personalized, web-based approach to treating insomnia. Unlike standard options like prescription sleep medications or cognitive behavioral therapy in person, SHUTi tailors its recommendations using data from each participant's sleep diary. This method allows users to engage with the program from the comfort of their own home, potentially increasing accessibility and adherence. Additionally, by delivering the treatment online, SHUTi offers flexibility and convenience, which can be particularly appealing for those with busy schedules or limited access to traditional sleep therapy resources.
What evidence suggests that SHUTi is effective for improving sleep in Black prostate cancer survivors?
Research has shown that SHUTi, an online treatment under study in this trial, effectively helps people sleep better. Studies have found that users sleep more efficiently, spending more time actually sleeping when in bed. Participants reported feeling more refreshed upon waking and falling asleep faster. For veterans, SHUTi improved sleep without requiring a therapist's assistance. Real-world data suggest that SHUTi leads to significant sleep improvements, with many users remaining engaged. Overall, SHUTi shows promise in helping people with insomnia achieve better sleep.12356
Are You a Good Fit for This Trial?
This trial is for Black/African American prostate cancer survivors struggling with insomnia. Participants should be comfortable using the internet as treatments are web-based. Specific eligibility criteria aren't provided, but typically participants must meet certain health conditions and agree to follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the SHUTi program or access to a patient education website over 6-9 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including data collection and questionnaires
What Are the Treatments Tested in This Trial?
Interventions
- Sleep Healthy Using the Internet (SHUTi)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor