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NCT04948996 · ClinicalTrials.gov registry record · NA
Treatment of Depression Using a Mobile Application in the Dominican Republic
A NA study, sponsored by Northern Illinois University.
- Terminated
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT04948996 is a NA study that was terminated before completion, run by Northern Illinois University. The registered enrollment target is 27 participants.
The verdict
NCT04948996, a NA study, was terminated before completion, sponsored by Northern Illinois University.
- TERMINATED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
The overall objective of this study is to develop a feasible and acceptable mental health app which delivers Cognitive Behavioral Therapy (CBT) for depressed patients in the Dominican Republic. This proposal meets the research objectives of NIMH in delivering mental health care to populations with low literacy, and supporting health care systems in monitoring and improving the quality of mental health. In the proposed study, the investigators will upgrade, implement, and evaluate a depression treatment app and assess trained facilitators' capacity in managing participants' depression symptoms using the app. The investigators will conduct a randomized controlled trial (RCT) among 120 participants who screen positive for mild to moderate depression or anxiety on the Patient Health Questionnaire (PHQ-9) or GAD- 7 via a university-based Covid mental health hotline. The app, El Buen Consejo Móvil (EBCM), will be downloaded to the participants' own Android phone. Participants will be randomized to receive the EBCM app with the functionality to connect individuals to one another via a facilitator-guided chat room (ECBM-G; n= 60) or to receive the same contents as an individualized facilitator-guided CBT program without the group functionality (ECBM-I; n=60). Recruitment and mixed-methods data collection will be conducted by phone, given current circumstances surrounding the Covid-19 pandemic. Process outcomes will be evaluated for the trained facilitators. The primary outcomes for app users will be acceptability of the app and perceptions of social interactivity for those randomized to the group condition. Validated questionnaires will be administered to measure perceived emotional support, loneliness, and interactivity. Level of adherence and effectiveness, the secondary outcomes, will be assessed by frequency of interaction with the app, completion of treatment for either treatment modality, and change in depressive symptoms. The investigators hypothesize that the use
Interventions
- BEHAVIORAL El Buen Consejo Móvil- Group (EBCM-G)
- BEHAVIORAL El Buen Consejo Móvil- Individual (EBCM-I)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-01-30 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04948996
The ClinicalTrials.gov registry entry for NCT04948996 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northern Illinois University, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which El Buen Consejo Móvil- Group (EBCM-G) is the first listed.
NCT04948996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04948996 about?
NCT04948996 is a clinical study titled "Treatment of Depression Using a Mobile Application in the Dominican Republic". The overall objective of this study is to develop a feasible and acceptable mental health app which delivers Cognitive Behavioral Therapy (CBT) for depressed patients in the Dominican Republic. This proposal meets the research objectives of NIMH in delivering mental health care to populations with l...
What is the current status of trial NCT04948996?
This trial is currently terminated. It is a NA study. The enrollment target is 27 participants. The study started on 2021-01-30. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT04948996?
The interventions under investigation include: El Buen Consejo Móvil- Group (EBCM-G) (BEHAVIORAL), El Buen Consejo Móvil- Individual (EBCM-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04948996?
This trial is sponsored by Northern Illinois University, which has 5 total clinical trials registered on ClinicalTrials.gov.
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