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NCT04587661 · ClinicalTrials.gov registry record · NA
Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment
A NA study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04587661: Clinical Trial NA study, sponsored by University of Pittsburgh.
NCT04587661 is a NA study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04587661, a NA study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
African Americans living with chronic health conditions are more likely to experience depression and other mental health disorders than their healthy counterparts, and are more likely to experience severe depression than whites, but less likely to be diagnosed or receive treatment. One especially vulnerable group is patients with sickle cell disease (SCD), a genetic blood disorder that primarily affects people of African descent, many of whom live in disadvantaged circumstances and are cared for in under-resourced settings. SCD causes severe acute and chronic pain, end-organ damage, and early mortality. Patients transitioning from adolescence to adulthood (ages16-30) are at high risk for mental health disorders and suicide. Using mobile technology, the investigators can provide high-quality, evidence-based behavioral mental health treatment that reaches patients in different settings. Digital cognitive behavioral therapy (CBT) is effective for treating depression and anxiety and can be brought to scale at low cost. Despite the promise of digital CBT, there are barriers to its widespread use, particularly in low-resource settings serving minorities. Qualitative data show that cultural factors-lack of relatability, representation, and perceived stigma regarding mental health treatment-limit engagement with digital CBT programs. Population-and setting-specific adaptations to interventions can lead to their successful implementation and wider use. The investigators will work with a digital CBT program to decrease stigma and make it more relatable and relevant to young adults with SCD, by devising changes to advertising and promotion, and tailoring communication with an integrated health coach, Aim 1: Use implementation science (ImS) and human-centered design methods to define the barriers to delivering routine mental health screening and digital CBT to adolescents and young adults with SCD. Aim 2: Rapidly iterate, test, and evaluate adaptations to the implementation st
Primary Outcome
A measure of participant engagement. {Number of times the app has been open per week}
Interventions
- BEHAVIORAL off-the-shelf digital CBT
- BEHAVIORAL adapted digital CBT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2023-01-04 |
| Phase | NA |
Why NCT04587661 stopped before completion
NCT04587661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which off-the-shelf digital CBT is the first listed.
NCT04587661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04587661 about?
NCT04587661 is a clinical study titled "Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment". African Americans living with chronic health conditions are more likely to experience depression and other mental health disorders than their healthy counterparts, and are more likely to experience severe depression than whites, but less likely to be diagnosed or receive treatment. One especially vu...
What is the current status of trial NCT04587661?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2020-08-12. Estimated completion is 2023-01-04.
What interventions are being tested in trial NCT04587661?
The interventions under investigation include: off-the-shelf digital CBT (BEHAVIORAL), adapted digital CBT (BEHAVIORAL).
Who is sponsoring clinical trial NCT04587661?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04587661's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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