Scaling Up Science-based Mental Health Interventions in Latin America

NCT ID: NCT03392883

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-13
• Study Completion Date: 2021-08-31

Brief Summary

Conduct systematic, multi-site mental health implementation research in both rural and urban primary care settings with a broad group of stakeholders in the US and Latin America.

Detailed Description

The investigators plan to launch and evaluate a new mental health service delivery model in Latin America. Specifically, in this new multi-component, mental health service delivery intervention, the investigators propose to: (1) harness mobile behavioral health technology for mental health (with a primary focus on depression and a secondary focus on problematic alcohol and other substance abuse), (2) launch new workforce training and service delivery models (including the integration of technology into service delivery), (3) launch and evolve an integrated data management system for systematic data tracking and outcomes assessment, and (4) launch and grow a learning collaborative of organizations integrating mental health into primary care. The investigators will launch this project at multiple primary care sites in various parts of Colombia, with a plan to inform subsequent adoption in several other Latin American countries, including Chile and Peru.

Conditions

Depression; Problematic Alcohol Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Digital Health Assisted Mental Healthcare

This Digital Health Assisted Mental Healthcare intervention will be based on the novel mobile-based platform (Laddr® from Square2 Systems).

Group Type: EXPERIMENTAL

Laddr

Intervention Type: BEHAVIORAL

Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. Specifically, the core functionality of Laddr (e.g., problem-solving therapy) will be structured to focus on an end user's management of depression and its impact on their functioning and quality of life. The program will secondarily focus on problematic alcohol use and its relationship to depression management.

Interventions

Laddr

Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. Specifically, the core functionality of Laddr (e.g., problem-solving therapy) will be structured to focus on an end user's management of depression and its impact on their functioning and quality of life. The program will secondarily focus on problematic alcohol use and its relationship to depression management.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged > 18 years
• Have worked for the study site for at least 3 months.

• Aged > 18 years
• Patients at one of our collaborating primary care sites
• Screen positive for minor (score of 5-9), moderate (score of 10-14), moderately severe (score of 15-19) or severe (score of 20-27) depression on Patient Health Questionnaire (PHQ-9)62 and/or screen positive for problematic alcohol use on Alcohol Use Disorder Identification Test (AUDIT) developed by the World Health Organization (a score of 8 or more on 10-item AUDIT)63 and have a confirmed diagnosis of depression and/or alcohol use disorder based on clinical consultation at the primary care site
• Willing to provide informed consent to use mobile intervention and complete study assessments

Exclusion Criteria

• Diagnosis with co-occurring severe mental illness (e.g., schizophrenia, bipolar disorder, depression with psychotic features)
• Alcohol withdrawal symptoms that require higher level of care (e.g., emergency medical or inpatient treatment)
• Express suicidal intention. This assessment will be based on a combination of a patient's response on the PHQ-9 assessment followed by further assessment by a primary care clinician. The PHQ-9 measure will not be used solely to determine eligibility on this criterion. Persons who express suicidal intention will immediately be provided immediate crisis management in accordance with the crisis management protocol at the collaborating primary care site.
• Intoxicated or otherwise impaired at the time of assessment (rendering the individual incapable of informed consent)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Javeriana

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lisa A. Marsch

Director of the Center for Technology and Behavioral Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa A Marsch, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Carlos Gomez-Restrepo, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Javeriana

Locations

ESE Hospital San Antonio de Guatavita

Guatavita, Cundinamarca, Colombia

Hospital Mario Gaitán Yanguas

Soacha, Cundinamarca, Colombia

Salud de Tundama

Duitama, Departamento de Boyacá, Colombia

Empresa Social del Estado Hospital Regional de Duitama- Santa Rosa de Viterbo Branch

Santa Rosa de Viterbo, Departamento de Boyacá, Colombia

Empresa Social del Estado Hospital Nelson Restrepo Martinez

Guayabal, Tolima Department, Colombia

Javesalud

Bogotá, , Colombia

Countries

Colombia

References

Marsch LA, Gomez-Restrepo C, Bartels SM, Bell K, Camblor PM, Castro S, Cardenas Charry MP, Cepeda M, Cubillos L, John D, Jassir MP, Lemley SM, Suarez-Obando F, Torrey WC, Uribe JM, Williams MJ. Scaling Up Science-Based Care for Depression and Unhealthy Alcohol Use in Colombia: An Implementation Science Project. Psychiatr Serv. 2022 Feb 1;73(2):196-205. doi: 10.1176/appi.ps.202000041. Epub 2021 Aug 4.

Reference Type: DERIVED

PMID: 34347504 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Patient Informed Consent form

View Document

Document Type: Informed Consent Form: Staff Informed Consent form

View Document

Other Identifiers

1U19MH109988

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1U19MH109988 D18019

Identifier Type: -

Identifier Source: org_study_id