Treatment of Depression Using a Mobile Application in the Dominican Republic

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.

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 Overview

• Status: Terminated
• Conditions: Depression Moderate; Depression Mild
• Intervention / Treatment: Behavioral: El Buen Consejo Móvil- Group (EBCM-G); Behavioral: El Buen Consejo Móvil- Individual (EBCM-I)

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • University Autonoma de Santo Domingo
• United States
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • University of Northern Illinois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: El Buen Consejo Móvil- Group (EBCM-G); Participants in the group condition will be placed in groups of five participants within the app. Their version of EBCM will have the functionality to connect individuals to one another via a facilitator-guided chat room (EBCM-G), where they can respond to suggested strategies within the app and communicate with each other or their facilitator guide using voice or text.	Behavioral: El Buen Consejo Móvil- Group (EBCM-G); Psycho-education and Information using a CBT "toolbox" approach.; 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").; 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.; 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.
Active Comparator: El Buen Consejo Móvil- Individual (EBCM-I); Participants randomized to EBCM-I will receive the same program contents without the group functionality.	Behavioral: El Buen Consejo Móvil- Individual (EBCM-I); Psycho-education and Information using a CBT "toolbox" approach.; 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").; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adapted Computer-Mediated Communication Questionnaire (CMCQ)	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 study, the adapted questions will explore these domains as they relate to app contents, engagement, mood states while using the app, and barriers and facilitators to app use. Follow-up open-ended questions will be administered alongside the close-ended questions to all participants in order to collect qualitative data that will provide context for interpreting the quantitative data.	Midline (three weeks)
Adapted Computer-Mediated Communication Questionnaire (CMCQ)	Participants' perceptions of acceptability and social interactivity of the app will be assessed a second time at endline (immediately after the end 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 study, the adapted questions will explore these domains as they relate to app contents, engagement, mood states while using the app, and barriers and facilitators to app use. Follow-up open-ended questions will be administered to a sub-set of at least 15 participants at endline; it is anticipated that this qualitative data will provide context for interpreting the quantitative data.	An average of six weeks
Adapted Depression Training Program Evaluation (DTPE)	The facilitators' impressions of the training and the app itself will be assessed through the administration of an adapted version of the Depression Training Program Evaluation (DTPE) at the end of the intervention period. Based on the Hartford Foundation's nurse depression training program, this tool assesses feasibility of implementation, perceived acceptability of the training, perceived changes in knowledge level and confidence in one's ability to identify and manage participants' depressive symptoms, perceived changes in confidence in one's ability to communicate with participants, and perceived outcomes of the intervention for participants. In the present study, the adapted data collection instrument includes both close-ended Likert-scale rating questions as well as open-ended questions with probes.	Through study completion; 18 months
Change in NIH Toolbox Emotional Support Scale score	Participants' perceived emotional support will be assessed at baseline (pre-intervention) and endline (post-intervention). Emotional support will be measured using the 8-item emotional support sub-scale from the validated Spanish version of the NIH Toolbox Social Relationship Scales. This sub-scale includes items related to having someone available with whom to discuss problems and who may provide empathy, support, and suggestions. The alpha coefficient of reliability for the emotional support sub-scale is 0.969. Participants rate the eight items on a five-point frequency scale (1-Never; 2-Rarely; 3-Sometimes; 4-Usually; 5-Always) over a past-month time frame. Scores may range from 8 to 40, with higher scores indicating greater levels of emotional support.	At Baseline (0 weeks) and at six weeks
Change in Three-Item Loneliness Scale score	Participants' perceived loneliness will be assessed at baseline (pre-intervention) and endline (post-intervention). Perceived loneliness will be measured through the Three-item Loneliness Scale, which was derived from the R-UCLA Loneliness Scale with the goal of providing a measure that is easy to administer through telephone surveys. The Three-item Loneliness Scale has high internal consistency and an alpha coefficient of reliability of 0.72. Participants respond to three questions about perceived loneliness using a three-point frequency scale (1-Hardly ever; 2-Some of the time; and 3-Often). Scores may range from 3 to 9, with higher scores indicating greater perceived loneliness.	At Baseline (0 weeks) and at 6 weeks
Adherence	Participant adherence to EBCM by ascertainment of number of sessions with participation (either voice or text response) divided by maximum number of sessions (10)	Week 1
Adherence	Participant adherence to EBCM by ascertainment of number of sessions with participation (either voice or text response) divided by maximum number of sessions (20)	Week 2
Adherence	Participant adherence to EBCM by ascertainment of number of sessions with participation (either voice or text response) divided by maximum number of sessions (30)	Week 3
Adherence	Participant adherence to EBCM by ascertainment of number of sessions with participation (either voice or text response) divided by maximum number of sessions (40)	Week 4
Adherence	Participant adherence to EBCM by ascertainment of number of sessions with participation (either voice or text response) divided by maximum number of sessions (50)	Week 5
Adherence	Participant adherence to EBCM by ascertainment of number of sessions with participation (either voice or text response) divided by maximum number of sessions (60)	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Staff/Patient interaction scale	To assess the facilitators' fidelity to and use of motivational interviewing (MI) practices, participants will complete the Measure of Staff/Patient interaction scale at endline. This 10-item scale measures the extent to which participants perceive that the facilitator is communicating in a manner that is supportive and reflective of MI principles. The scale factors align with the the three components of MI: collaboration with the client; elicitation of client's own ideas about change; and autonomy/support to encourage the patient's decision-making. The factors have alpha coefficients of reliability ranging from 0.73-0.94; the overall scale has an alpha coefficient of 0.90. The rater (i.e. the participant) rates each items on a five-point frequency scale ranging from 1-Never to 5-Always or almost always. After reverse-scoring three items, final scores may range from 10 to 50, with higher scores indicating greater levels of fidelity to MI strategies.	At six weeks
Internet-delivered Cognitive Behavior Therapy - Therapist Rating Scale (ICBT-TRS)	The Internet-delivered Cognitive Behavioral Therapy-Therapist Rating Scale (ICBT-TRS) will be employed to assess facilitator fidelity to the communication strategies delivered through the training for coaching participants. This validated behavioral checklist rates the adherence and quality of usage of specific behavior change communication strategies related to nine domains such as "Builds Rapport" and "Praises Effort." The scale has demonstrated excellent inter-rater reliability in total scores (ICC = 0.91; CI = 0.78, 0.97). For each domain, the study subject is given a rating of 0 (absence of behavior), 1 (inadequate performance/significant recommendations made), or 3 (adequate performance/minor recommendations). Scores may range from 0 to 27, with higher scores indicating increased fidelity. In the present study, the PI and co-I will use the ICBT-TRS to examine the facilitators' communication with participants throughout the intervention period.	Intervention Weeks 1-6
Change in Patient Health Questionnaire (PHQ-9) score	Level of depression will be assessed by the Patient Heath Questionnaire (PHQ-9), which consists of the nine criteria on which DSM-IV diagnosis of depressive disorders is based. Each of the nine items is scored on a three-point frequency scale ranging from 0-"not at all" to 3-"nearly every day" for the previous two weeks. A score of 5-9 indicates mild depression; 10-14, moderate depression; 15-19, moderately severe depression; and 20-27, severe depression. In large scale primary care studies, sensitivity was 88% and specificity was 88% for major depression at a score of greater than or equal to 10. The Spanish version has demonstrated good to excellent reliability in various Latin American countries. In the present study, the PHQ-9 will be administered on four occasions within the app (weeks 1, 2, 4, and 5) and on two occasions by phone (weeks 3 and 6). It is anticipated that a decrease of 5 points on the PHQ-9 will result from participating in the full 6-week intervention.	Baseline - 0 weeks and at Week 1
Change in Patient Health Questionnaire (PHQ-9) score	Level of depression will be assessed by the Patient Heath Questionnaire (PHQ-9), which consists of the nine criteria on which DSM-IV diagnosis of depressive disorders is based. Each of the nine items is scored on a three-point frequency scale ranging from 0-"not at all" to 3-"nearly every day" for the previous two weeks. A score of 5-9 indicates mild depression; 10-14, moderate depression; 15-19, moderately severe depression; and 20-27, severe depression. In large scale primary care studies, sensitivity was 88% and specificity was 88% for major depression at a score of greater than or equal to 10. The Spanish version has demonstrated good to excellent reliability in various Latin American countries. In the present study, the PHQ-9 will be administered on four occasions within the app (weeks 1, 2, 4, and 5) and on two occasions by phone (weeks 3 and 6). It is anticipated that a decrease of 5 points on the PHQ-9 will result from participating in the full 6-week intervention.	Baseline - 0 weeks and at Week 2
Change in Patient Health Questionnaire (PHQ-9) score	Level of depression will be assessed by the Patient Heath Questionnaire (PHQ-9), which consists of the nine criteria on which DSM-IV diagnosis of depressive disorders is based. Each of the nine items is scored on a three-point frequency scale ranging from 0-"not at all" to 3-"nearly every day" for the previous two weeks. A score of 5-9 indicates mild depression; 10-14, moderate depression; 15-19, moderately severe depression; and 20-27, severe depression. In large scale primary care studies, sensitivity was 88% and specificity was 88% for major depression at a score of greater than or equal to 10. The Spanish version has demonstrated good to excellent reliability in various Latin American countries. In the present study, the PHQ-9 will be administered on four occasions within the app (weeks 1, 2, 4, and 5) and on two occasions by phone (weeks 3 and 6). It is anticipated that a decrease of 5 points on the PHQ-9 will result from participating in the full 6-week intervention.	Baseline - 0 weeks and at Week 3
Change in Patient Health Questionnaire (PHQ-9) score	Level of depression will be assessed by the Patient Heath Questionnaire (PHQ-9), which consists of the nine criteria on which DSM-IV diagnosis of depressive disorders is based. Each of the nine items is scored on a three-point frequency scale ranging from 0-"not at all" to 3-"nearly every day" for the previous two weeks. A score of 5-9 indicates mild depression; 10-14, moderate depression; 15-19, moderately severe depression; and 20-27, severe depression. In large scale primary care studies, sensitivity was 88% and specificity was 88% for major depression at a score of greater than or equal to 10. The Spanish version has demonstrated good to excellent reliability in various Latin American countries. In the present study, the PHQ-9 will be administered on four occasions within the app (weeks 1, 2, 4, and 5) and on two occasions by phone (weeks 3 and 6). It is anticipated that a decrease of 5 points on the PHQ-9 will result from participating in the full 6-week intervention.	Baseline - 0 weeks and at Week 4
Change in Patient Health Questionnaire (PHQ-9) score	Level of depression will be assessed by the Patient Heath Questionnaire (PHQ-9), which consists of the nine criteria on which DSM-IV diagnosis of depressive disorders is based. Each of the nine items is scored on a three-point frequency scale ranging from 0-"not at all" to 3-"nearly every day" for the previous two weeks. A score of 5-9 indicates mild depression; 10-14, moderate depression; 15-19, moderately severe depression; and 20-27, severe depression. In large scale primary care studies, sensitivity was 88% and specificity was 88% for major depression at a score of greater than or equal to 10. The Spanish version has demonstrated good to excellent reliability in various Latin American countries. In the present study, the PHQ-9 will be administered on four occasions within the app (weeks 1, 2, 4, and 5) and on two occasions by phone (weeks 3 and 6). It is anticipated that a decrease of 5 points on the PHQ-9 will result from participating in the full 6-week intervention.	Baseline - 0 weeks and at Week 5
Change in Patient Health Questionnaire (PHQ-9) score	Level of depression will be assessed by the Patient Heath Questionnaire (PHQ-9), which consists of the nine criteria on which DSM-IV diagnosis of depressive disorders is based. Each of the nine items is scored on a three-point frequency scale ranging from 0-"not at all" to 3-"nearly every day" for the previous two weeks. A score of 5-9 indicates mild depression; 10-14, moderate depression; 15-19, moderately severe depression; and 20-27, severe depression. In large scale primary care studies, sensitivity was 88% and specificity was 88% for major depression at a score of greater than or equal to 10. The Spanish version has demonstrated good to excellent reliability in various Latin American countries. In the present study, the PHQ-9 will be administered on four occasions within the app (weeks 1, 2, 4, and 5) and on two occasions by phone (weeks 3 and 6). It is anticipated that a decrease of 5 points on the PHQ-9 will result from participating in the full 6-week intervention.	Baseline - 0 weeks and at Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Service delivery	Pre-intervention proportions of patients with MDD who are ineligible for study participation who are referred to treatment.	Baseline - Week 0
Change in Generalized Anxiety Disorder Scale (GAD-7) score	Level of anxiety will be assessed by the Generalized Anxiety Disorder Score (GAD-7) score which consists of the seven criteria on which DSM-IV diagnosis of anxiety disorders is based. Each of the seven items is scored on a three-point frequency scale ranging from 0-"not at all" to 3-"nearly every day" for the previous two weeks.	Baseline - 0 weeks; Week 3
Change in Generalized Anxiety Disorder Scale (GAD-7) score	Level of anxiety will be assessed by the Generalized Anxiety Disorder Score (GAD-7) score which consists of the seven criteria on which DSM-IV diagnosis of anxiety disorders is based. Each of the seven items is scored on a three-point frequency scale ranging from 0-"not at all" to 3-"nearly every day" for the previous two weeks.	Baseline - 0 weeks; Week 6

Collaborators and Investigators

• Sponsor: Northern Illinois University
• Collaborators: University Autonoma de Santo Domingo
• Investigators: Principal Investigator: Susan Caplan, PhD, Northern Illinois University

Publications and helpful links

General Publications

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Helpful Links

• VoiceThread, LLC. (2016)
• Digital In 2018 in the Caribbean: Essential Insights Into Internet, Social Media, Mobile, And Ecommerce Use Across The Region Part 1:West
• iDiabetes Care bundle - Reference in Clinical Diabetes - American Diabetes Association Magazine
• The MacArthur Foundation. Depression Management Tool Kit. The John D. & Cather T. MacArthur Foundation's Initiative on Depression and Primary Care 2009

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: depression; mobile health; primary care; motivational interviewing; global health; capacity building
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 1R21MH119851-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Research resources generated with funds from this grant will be freely distributed, as available, to qualified academic investigators for noncommercial research. The investigators at University of Northern Illinois and the University Autonoma de Santo Domingo, will ensure that clinical trial(s) under the award are registered and results information is submitted to ClinicalTrials.gov
• IPD Sharing Time Frame: Six months after initial recruitment until 10 years after study completion
• IPD Sharing Access Criteria: Data will be shared to qualified researchers through presentations at scientific meetings, through ClinicalTrials.gov and the NIMH Database Archives following NIH guidelines. Data will be distributed without cost to approved outside collaborators under appropriate agreements for noncommercial research. Approved outside collaborators will be sponsored by an institution with an FWA assurance number, have a research-related need for the information, and certify the research need by submitting a Data Use Certification. We will make the data and associated documentation available to users only under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. No additional funds are needed for this plan.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No