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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: Clinical Trial NA study, sponsored by Northern Illinois University.
NCT04948996 is a NA study that was terminated before completion, run by Northern Illinois University. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Participants' perceptions of acceptability and social interactivity of the app will first be assessed at midline (three weeks after initiation of the 6-week intervention) through close-ended rating scale questions derived from the Computer-Mediated Communication Questionnaire (CMCQ). The CMCQ measures attitudes towards tech-mediated communication, consisting of four domains: social context, privacy, interactivity, and online communication (alpha coefficient of reliability = 0.83). In the present
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 |
Why NCT04948996 stopped before completion
NCT04948996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which El Buen Consejo Móvil- Group (EBCM-G) is the first listed.
NCT04948996 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04948996's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 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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