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COMPLETED NA

Reducing Health Disparities for Black Women in the Treatment of Insomnia

NCT03613519 · View on ClinicalTrials.gov ↗

Study Summary

Black women are at a higher risk of developing insomnia than other women and insomnia has profound adverse physical and psychological health consequences. There is an internet-delivered treatment program for insomnia that has been shown to be effective in White individuals but there is little evidence of the effectiveness of this treatment among Black women. The goal of this study is to conduct a comparative effectiveness trial of three online insomnia therapies after a 6 month follow-up period--a cognitive behavioral therapy for insomnia (CBT-I) called SHUTi (Sleep Healthy Using the Internet), SHUTi modified for Black women (SHUTi-BWHS), and patient education (PE) (usual treatment). This study aims to provide the much needed evidence to help Black women make informed decisions regarding treatment for their insomnia.

Conditions Studied

Interventions

  • BEHAVIORAL Patient education
  • BEHAVIORAL SHUTi
  • BEHAVIORAL modified SHUTi (i.e., SHUTi-BWHS)

Study Locations (1)

Massachusetts

  • Slone Epidemiology Center at Boston University — Boston

Trial Details

FieldValue
Enrollment Target 333 participants
Start Date 2019-10-08
Est. Completion 2021-03-09
Phase NA

Sponsor

Boston University

150 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03613519

The ClinicalTrials.gov registry entry for NCT03613519 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 150 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 3 interventions — of which Patient education is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03613519 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03613519 about?

NCT03613519 is a clinical study titled "Reducing Health Disparities for Black Women in the Treatment of Insomnia". Black women are at a higher risk of developing insomnia than other women and insomnia has profound adverse physical and psychological health consequences. There is an internet-delivered treatment program for insomnia that has been shown to be effective in White individuals but there is little eviden...

What is the current status of trial NCT03613519?

This trial is currently completed. It is a NA study. The enrollment target is 333 participants. The study started on 2019-10-08. Estimated completion is 2021-03-09.

What conditions does trial NCT03613519 study?

This clinical trial studies the following conditions: Insomnia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03613519?

The interventions under investigation include: Patient education (BEHAVIORAL), SHUTi (BEHAVIORAL), modified SHUTi (i.e., SHUTi-BWHS) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03613519?

This trial is sponsored by Boston University, which has 150 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03613519 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial