NCT04948996

Treatment of Depression Using a Mobile Application in the Dominican Republic

Terminated NA Last updated 8 June 2022

What this trial tests

NA trial testing El Buen Consejo Móvil- Group (EBCM-G) in Depression Mild in 27 participants. Terminated before completion.

Timeline

30 January 2021

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Northern Illinois University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	27
Start date	30 January 2021
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	2 locations across United States, Dominican Republic

Drugs / interventions tested

• El Buen Consejo Móvil- Group (EBCM-G)
• El Buen Consejo Móvil- Individual (EBCM-I)

Conditions studied

• Depression Mild — all drugs for Depression Mild →
• Depression Moderate — all drugs for Depression Moderate →

Sponsor

Northern Illinois University

Who can join

Adults 18 to 110, any sex, with Depression Mild or Depression Moderate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 of the app for guided self-help can be enhanced through group interaction. EBCM can result in increased access to care in low-income community settings where patients are not currently receiving treatment due to logistical barriers and the stigma of seeking care in a mental health care setting.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.