Web-based Treatment for Insomnia

(SIESTA-P Trial)

TB
Overseen ByTraci Bethea
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Georgetown University

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

Self-identifies as Black/African American
Able to read and understand English
I have a smart device with internet or can attend weekly study appointments and calls.
See 4 more

Exclusion Criteria

Employed in an occupation where sleep restriction could be a harm to themselves or others
Actively employed in shift work
Diagnosed with a severe/major psychiatric disorder
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the SHUTi program or access to a patient education website over 6-9 weeks

6-9 weeks
6 sessions (online)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including data collection and questionnaires

10-12 weeks
1 visit (online)

What Are the Treatments Tested in This Trial?

Interventions

  • Sleep Healthy Using the Internet (SHUTi)
Trial Overview The trial tests an online cognitive behavioral therapy program for insomnia called SHUTi against a control group receiving patient education through an educational website. The goal is to see if SHUTi can improve sleep quality and overall well-being in this specific survivor group.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sleep Healthy Using the Internet (SHUTi)Experimental Treatment1 Intervention
Group II: Patient educationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials
355
Recruited
142,000+

Citations

Sleep Healthy Using the Internet (SHUTi)The study showed increases in sleep efficiency, soundness of sleep, and feeling refreshed upon awakening and decreases in sleep onset latency, ...
Efficacy of an Internet-Delivered Intervention for Improving ...The objective of this study was to evaluate the efficacy of an unguided iCBT-I (Sleep Healthy Using the Internet [SHUTi]) among veterans.
Sleep Healthy Using The Internet for Older Adult Sufferers ...This study will compare the efficacy of an interactive internet intervention for older adults with insomnia called SHUTi OASIS (Sleep Healthy Using the ...
Real-world evidence from users of a behavioral digital ...Real-world data suggest that digital therapeutics can result in relatively high levels of engagement and clinically meaningful sleep improvements.
A randomized controlled trial of a digital cognitive ...This study evaluated the efficacy of Sleep Healthy Using the Internet for Older Adults Suffering with Insomnia and Sleeplessness (SHUTi OASIS),
Cognitive Mechanisms of Sleep Outcomes in a ...Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep ...
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