Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03613519 · ClinicalTrials.gov registry record · NA
Reducing Health Disparities for Black Women in the Treatment of Insomnia
A NA study of Insomnia, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 333
- Enrollment target
- 1
- Study location
NCT03613519: Completed NA study of Insomnia, sponsored by Boston University.
NCT03613519 is a NA study of Insomnia that has completed, run by Boston University. The registered enrollment target is 333 participants, above the 168-participant average among 151 other Insomnia trials with a reported enrollment target (98% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03613519, a NA study of Insomnia, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 333 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
A change in sleep difficulties will be assessed by the change in the ISI (Insomnia Severity Index) score. The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the past month. The specific items evaluate the severity of difficulties with sleep onset, sleep maintenance, and early morning awakening; sleep dissatisfaction; interference of sleep problems with daytime functioning; noticeability of sleep difficulties by others; and distress caused by s
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
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2021-03-09 |
| Phase | NA |
What the finished NCT03613519 record still lists
NCT03613519 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, above the 168-participant average among 151 other Insomnia trials with a reported enrollment target (98% higher).
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.
NCT03613519 reports a single indexed study location in Massachusetts.
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.
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).
Who is sponsoring clinical trial NCT03613519?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03613519's enrollment target sits among peer trials
333 21st of 151 higher than 131 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Treatments for Insomnia in Veterans With PTSD
RECRUITING · NA
-
Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
RECRUITING · NA
-
mPATH for Low-income Older Adults
RECRUITING · NA
-
Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD
RECRUITING · NA
-
Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study
RECRUITING · NA
-
Treatments in Women Veterans With Insomnia and PTSD
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07395687 · 333 participants · Phase 2
A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity
- NCT05131672 · 334 participants · NA
Cast or Operation for Medial Epicondyle Fracture Treatment in Children
- NCT05131685 · 334 participants · NA
Distal Radius Interventions for Fracture Treatment
- NCT05546931 · 334 participants · NA
Mobile Health Program for Rural Hypertension
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI