Treatment of Depression Using a Mobile Application in the Dominican Republic

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 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.

Conditions

• Depression Mild
• Depression Moderate

Interventions

BEHAVIORAL

El Buen Consejo Móvil- Group (EBCM-G)

1. Psycho-education and Information using a CBT "toolbox" approach. 2. Self-Assessment to track, label and describe moods by daily prompts to state or text level of mood on the mood tracker ("termómetro de animo"). 3. Symptom Identification and Management: after identifying a label for type of thinking from a pull-down list, a corresponding short 1-3-minute recorded strategy such as Thought Stopping, Increasing Pleasurable Activity, Mindfulness or Priming will be provided. 4. Monitoring of treatment engagement and response to treatment: Reminders to engage will include text messages and phone calls from the facilitator to encourage use of the app according to a scripted protocol. Additionally, participants in the Group Intervention will be able to communicate with and respond to one another through the group chat rooms within the app.

BEHAVIORAL

El Buen Consejo Móvil- Individual (EBCM-I)

1. Psycho-education and Information using a CBT "toolbox" approach. 2. Self-Assessment to track, label and describe moods by daily prompts to state or text level of mood on the mood tracker ("termómetro de animo"). 3. Symptom Identification and Management: after identifying a label for type of thinking from a pull-down list, a corresponding short 1-3-minute recorded strategy such as Thought Stopping, Increasing Pleasurable Activity, Mindfulness or Priming will be provided. 4. Monitoring of treatment engagement and response to treatment: Reminders to engage will include text messages and phone calls from the facilitator to encourage use of the app according to a scripted protocol.

Sponsors & Collaborators

• University Autonoma de Santo Domingo

  collaborator UNKNOWN

• Northern Illinois University

  lead OTHER

Principal Investigators

• Susan Caplan, PhD · Northern Illinois University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-30

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• United States
• Dominican Republic

Study Locations