Clinical trial NCT04948996: Treatment of Depression Using a Mobile Application in the Dominican Republic
Official title: Effectiveness of Group Versus Individual Self-management of Depression Using a Mobile App to Increase Treatment Adherence Among Users of a University-based Helpline in the Dominican Republic.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression Mild
Depression Moderate
Keywords: depression
primary care
mobile health
motivational interviewing
global health
capacity building
Lead sponsor: Northern Illinois University
Sponsor class: OTHER
Collaborators: name: University Autonoma de Santo Domingo
First posted: 2021-07-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Adapted Computer-Mediated Communication Questionnaire (CMCQ)
timeFrame: Midline (three weeks)
measure: Adapted Computer-Mediated Communication Questionnaire (CMCQ)
timeFrame: An average of six weeks
measure: Adapted Depression Training Program Evaluation (DTPE)
timeFrame: Through study completion; 18 months
measure: Change in NIH Toolbox Emotional Support Scale score
timeFrame: At Baseline (0 weeks) and at six weeks
measure: Change in Three-Item Loneliness Scale score
timeFrame: At Baseline (0 weeks) and at 6 weeks
measure: Adherence
timeFrame: Week 1
measure: Adherence
timeFrame: Week 2
measure: Adherence
timeFrame: Week 3
measure: Adherence
timeFrame: Week 4
measure: Adherence
timeFrame: Week 5
measure: Adherence
timeFrame: Week 6
Secondary outcomes:
measure: Measure of Staff/Patient interaction scale
timeFrame: At six weeks
measure: Internet-delivered Cognitive Behavior Therapy - Therapist Rating Scale (ICBT-TRS)
timeFrame: Intervention Weeks 1-6
measure: Change in Patient Health Questionnaire (PHQ-9) score
timeFrame: Baseline - 0 weeks and at Week 1
measure: Change in Patient Health Questionnaire (PHQ-9) score
timeFrame: Baseline - 0 weeks and at Week 2
measure: Change in Patient Health Questionnaire (PHQ-9) score
timeFrame: Baseline - 0 weeks and at Week 3
measure: Change in Patient Health Questionnaire (PHQ-9) score
timeFrame: Baseline - 0 weeks and at Week 4
measure: Change in Patient Health Questionnaire (PHQ-9) score
timeFrame: Baseline - 0 weeks and at Week 5
measure: Change in Patient Health Questionnaire (PHQ-9) score
timeFrame: Baseline - 0 weeks and at Week 6
Other outcomes:
measure: Service delivery
timeFrame: Baseline - Week 0
measure: Change in Generalized Anxiety Disorder Scale (GAD-7) score
timeFrame: Baseline - 0 weeks; Week 3
measure: Change in Generalized Anxiety Disorder Scale (GAD-7) score
timeFrame: Baseline - 0 weeks; Week 6
Locations:
city: DeKalb
country: United States
facility: University of Northern Illinois
state: Illinois
city: Santo Domingo
country: Dominican Republic
facility: University Autonoma de Santo Domingo
Study officials:
affiliation: Northern Illinois University
name: Susan Caplan, PhD
role: PRINCIPAL_INVESTIGATOR
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