Recruiting

SHUTi & Education

Sponsor:

Georgetown University

Code:

NCT07128927

Conditions

Insomnia

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Sleep Healthy Using the Internet (SHUTi)

Patient education

Study Details

Brief summary:

This pilot study will recruit Black/African American prostate cancer survivors into a clinical trial and will randomize each person to 1 of 2 possible treatments - an internet-based treatment for insomnia called Sleep Healthy Using the Internet (SHUTi) or an educational website. SHUTi provides the treatment - cognitive behavioral therapy for insomnia - across 6 lessons, while the educational website is like an online patient brochure. The study will examine the feasibility of SHUTi to improve sleep and well-being among Black prostate cancer survivors. It will also examine whether SHUTi is acceptable to these survivors and will compare the effect of SHUTi versus the educational website on insomnia and non-insomnia patient-reported outcomes.

Conditions

Insomnia

Study ID

NCT07128927

Start date

Dec 1, 2025

Status verified date

Dec, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥21 years
  • Self-identifies as Black/African American
  • Diagnosed with invasive prostate cancer (AJCC stages I-IV) within 5 years
  • Has not received surgery, chemotherapy, or radiation within the previous 3 months
  • Has a smart phone, tablet, or computer with reliable internet access or willing to attend a weekly study appointment and to complete a weekly phone call
  • Has clinically relevant insomnia symptoms (i.e., score ≥10 on the Insomnia Severity Index)
  • Able to read and understand English

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
  • Diagnosed with a seizure disorder or recently (≤12 months) experienced a seizure
  • Unable to consent

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sleep Healthy Using the Internet (SHUTi)

SHUTi provides 6 sessions of 45-60 minutes in length delivered over the course of 6-9 weeks. The program tailors recommendations based on sleep diary data provided by each participant.

placebo comparator: Patient education

Static information about insomnia provided on a patient education website

Interventions

Sleep Healthy Using the Internet (SHUTi)

Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia

Patient education

Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.

Primary outcome measure

  • Feasibility of study protocol [ Time Frame: 10-12 weeks ]
  • Acceptability of intervention [ Time Frame: 10-12 weeks ]

Central Contacts and Locations

Central contacts

Traci Bethea

202-687-5367siestap@georgetown.edu

Locations

Georgetown Lombardi Comprehensive Cancer Center

Recruiting

Washington D.C., District of Columbia, United States, 20003

Contacts

Traci Bethea

202-687-5367siestap@georgetown.edu

Principal Investigator:

Traci Bethea

More Information

Sponsor

Georgetown University

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • insomnia
  • Sleep Healthy Using the Internet (SHUTi)
  • prostate cancer survivorship
  • cognitive behavioral therapy for insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2025-12-05.