Purpose:
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.
Study summary:
Study design:
The investigators will implement an Optimization, Effectiveness and Implementation (OEI)
Hybrid Trial, based upon preliminary work. During the first six months, the investigators
will upgrade and modify the mental health app, EBCM, to improve the interface and user
friendliness.
Aim 1 (Optimization): Investigators will integrate app enrollment within a mental health
hotline staffed by research assistants who are licensed psychologists. Protocols will be
developed and produced for all hotline volunteers, including depression screening, evaluation
and criteria for referral, and recruitment of individuals for study participation.
Facilitators will receive extensive training for encouraging and guiding participants in
usage of the app, and for facilitating chat rooms among the EBCM-G study arm. Process
outcomes assessed among the app facilitators will include 1) feasibility, 2) fidelity, 3)
acceptability of the training, and 4) perceived confidence in identifying and managing
patients' symptoms of depression.
Aim 2 (Effectiveness and Implementation): Investigators will conduct an RCT with 120
participants who will be randomized to receive either the group treatment modality (El Buen
Consejo Móvil-Group; EBCM-G) or the individual treatment modality (El Buen Consejo
Móvil-Individual; EBCM-I). Participants will be followed for the duration of the 6-week
intervention. Participants randomized to EBCM-G will be placed in groups of five participants
within the app. Their version of the app will have the functionality to connect individuals
to one another via a facilitator-guided chat room where they may respond to suggested
strategies within the app and communicate with each other or their facilitator using voice or
text. Participants randomized to EBCM-I will receive the same program contents without the
group functionality.
Procedures:
For study recruitment, research assistants staffing the hotline will screen patients
initially with the PHQ-2,and GAD-2 followed by the PHQ-9 and/or GAD-7 if positive, and will
refer individuals with mild to moderate depression to the research team for an explanation of
the study and the informed consent process.
Study participants will undergo baseline data collection after providing informed consent,
and will then be provided with one week of prepaid internet access to allow them to download
and begin using the EBCM app. Upon installing the app, participants will watch an an
introductory video on how to navigate the app. After initial log-in, participants will be
randomized to EBCM-G or EBCM-I using a computer-generated randomization series. After
demonstrating engagement with the app during the first week, participants will receive
additional prepaid internet access to continue using the app during the subsequent five
weeks. EBCM will be delivered in twice daily 1-3-minute presentations.
The facilitators will undergo extensive training and will also formally consent to study
participation. They will participate in mock-trials of dissemination, and interviews
concerning implementation of the app. For their training in facilitation of treatment
engagement, they will first receive two days of training in the scripted protocol for app
coaching including the previously developed EMPDA Motivational Interviewing intervention,
such as the use of supportive dialogue such as praise, reminders, non-judgmental suggestions.
Facilitators will also be trained in criteria for referral in the event of symptom
exacerbation or suicidal ideation as well as confidentiality and privacy during this first
phase of training.
Second, the facilitators will participate in a one-week trial period of the EBCM app where
supportive dialogue will be modeled by the PI's responses to comments within the app. Third,
through the administration of the Internet-delivered CBT - Therapist Rating Scale (ICBT-TRS),
the investigators will provide feedback to the facilitators related to their fidelity to CBT
principles. During the first week, monitoring and responses will be provided on a daily basis
according to a scripted protocol, while during the second and third weeks, the facilitators
will review the responses to each session three times/week and offer feedback to each
participant. Finally, during Weeks 4-6, participants will receive responses on a twice weekly
basis. The facilitators will participate in weekly in group discussions with the PI (Dr.
Susan Caplan) and Co-Investigator (Lic. Angelina Sosa Lovera) using a secure group platform
to share information and reinforce best practices.
Criteria:
Participants in Aim 1, research assistants/facilitators:
Inclusion criteria:
- Equal to or greater than age 18 years of age
- Baccalaureate degree in psychology
- Licensed as a clinical psychologist
- Able to speak and understand Spanish and read at a third grade level (for texting
within the app).
Exclusion criteria:
- Age under 18 years
Participants in Aim 2, app users:
Inclusion criteria:
- Equal to or greater than age 18 years of age
- Have a positive score on the Patient Health Questionnaire (PHQ-9) of >/=5 and <15
(indicating mild to moderate depressive disorder)
- Have access to a working mobile smart phone
- Able to speak and understand Spanish and read at a third grade level (for texting
within the app).
Exclusion criteria:
- age under 18 years
- PHQ-9 score < 5 or >/=15
- A history of psychiatric hospitalization for bipolar disorder, severe mental disorder,
significant cognitive impairment, hearing or speech impairment, non-Spanish speaking