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NCT03044145 · ClinicalTrials.gov registry record · NA
The Cultural Formulation Interview-Engagement Aid
A NA study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT03044145 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 54 participants.
The verdict
NCT03044145, a NA study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study Summary
This study consists of two projects: Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and 9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician feedback in a pre-pilot trial. The study team will first train clinicians in the CFI-EA by reading over the CFI-EA treatment manual and practicing how they can use it in behavioral simulations, and then check whether participants think they can do it (feasibility) and like it (acceptability) through standard measures. Following this the study team will revise the CFI-EA based on their feedback for the comparative open trial in Phase 2. Project 2: The study team will test the revised CFI-EA against treatment as usual in a pilot trial. 3 clinicians and 12-15 patients will be enrolled in each arm. As before, the study team will first train clinicians in the revised CFI-EA by reading over the CFI-EA treatment manual and practicing how they can use it in behavioral simulations. Then, the study team will check whether participants think they can do it (feasibility) and like it (acceptability) through standard measures, and in addition will also explore any initial effects on communication behaviors among patients and clinicians and treatment engagement based on treatment retention. The specific aims are: For Project 1: 1. To pretest the CFI-EA intervention in a mental health setting through a pre-pilot open trial that explores communication mechanisms of action in terms of communication behavior and cultural content, and 2. To revise the CFI-EA intervention based on patient and clinician feedback on its feasibility and acceptability. As real-world community stakeholders for whom the CFI-EA is being developed, patients and clinicians can provide helpful perspectives on how the CFI-EA can help clinicians tailor treatment plans around patient cultural views and treatment preferences to keep patients in care. The CFI-EA will be revised around areas of max
Interventions
- BEHAVIORAL The Cultural Formulation Interview-Engagement Aid in Project 1
- BEHAVIORAL The Cultural Formulation Interview-Engagement Aid Revised for Project 2
- BEHAVIORAL Treatment as usual for Project 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2016-09-20 |
| Est. Completion | 2018-09-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03044145
The ClinicalTrials.gov registry entry for NCT03044145 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which The Cultural Formulation Interview-Engagement Aid in Project 1 is the first listed.
NCT03044145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03044145 about?
NCT03044145 is a clinical study titled "The Cultural Formulation Interview-Engagement Aid". This study consists of two projects: Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and 9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician feedback in a pre-pilot trial. The study team will first train clinicians in the...
What is the current status of trial NCT03044145?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2016-09-20. Estimated completion is 2018-09-05.
What interventions are being tested in trial NCT03044145?
The interventions under investigation include: The Cultural Formulation Interview-Engagement Aid in Project 1 (BEHAVIORAL), The Cultural Formulation Interview-Engagement Aid Revised for Project 2 (BEHAVIORAL), Treatment as usual for Project 2 (BEHAVIORAL).
Who is sponsoring clinical trial NCT03044145?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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