Clinical trial NCT03392883: Scaling Up Science-based Mental Health Interventions in Latin America
Official title: Scaling Up Science-based Mental Health Interventions in Latin America
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Problematic Alcohol Use
Keywords: Latin America
Depression
mHealth
Problematic Alcohol Use
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Javeriana
name: National Institute of Mental Health (NIMH)
First posted: 2018-01-08
Enrollment: 1348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will initially pilot test this mental health service delivery model at a single primary care site and then refine the model based on pilot data. The investigators will then expand implementation across 6 Colombia-based healthcare sites in urban and rural communities (including approximately 2000 participants). Consistent with a modified stepped wedge design (multiple baseline design), the investigators will implement the model across sites on a staggered basis and expand the number of sites in which the investigators implement over time. By conducting this multi-site implementation research project, the investigators can assess the extent to which the implementation model and associated outcomes are replicable across sites and/or the extent to which the model needs to be modified for differing contexts.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Provider and administrative staff Inclusion Criteria:

  * Aged \> 18 years
  * Have worked for the study site for at least 3 months.
* Participant Inclusion Criteria:

  * 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:

-Participant 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)

Primary outcomes:
measure: The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument
timeFrame: At 6- and 12-month follow-up visits with a sub-sample of participants
measure: The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument
timeFrame: At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.
measure: The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument
timeFrame: At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.
measure: The Program Sustainability Assessment Tool (PSAT) Providers
timeFrame: At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.
measure: The Program Sustainability Assessment Tool (PSAT) Administrative Staff
timeFrame: At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: This patient measure were assessed at baseline and every 3 months thereafter for a period of 12 months (for a total of 5 assessment timepoints per patient).
measure: 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints-level assessments per patient).
measure: General Anxiety Disorder Screener (GAD-7)
timeFrame: This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
measure: The Quick Drinking Screen (QDS) (for Full Implementation Study Only)
timeFrame: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with implementation study participants).
Other outcomes:
measure: EuroQOL Five Dimensions Questionnaire (EQ-5D) (Only for Pilot Participants)
timeFrame: This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants).
measure: EuroQol Visual Analogue Scale (EQ-VAS) (Only for Pilot Participants)
timeFrame: This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants).
measure: Alcohol Timeline Follow-back (Alcohol TLFB) (Only for Pilot Participants)
timeFrame: This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants).
measure: Behavioral Health Integration in Medical Care Index (BHIMC)
timeFrame: Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021).
measure: The Time-driven Activity-based Costing (TDABC) Approach
timeFrame: Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021).
measure: Non-Study Medical and Other Services (NSMOS)
timeFrame: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
measure: Non-Medical Expenses for Depression (NMED)
timeFrame: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
measure: Health and Work Performance Questionnaire (HPQ)
timeFrame: At baseline, 6-month follow-ups, and 12-month follow-ups (for a total of 3 assessment timepoints per patient).
measure: Administrative Interviews
timeFrame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
measure: Patient Utilization Interviews/Observations
timeFrame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
measure: Provider Interviews
timeFrame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
measure: COVID-19 Impact Survey
timeFrame: Patients will be assessed once at a follow-up visit every 3 months or at a separately scheduled visit. Providers and administrators will be assessed once at a follow-up visit every 6 months or at a separate visit.
Locations:
city: Duitama
country: Colombia
facility: Salud de Tundama
state: Boyaca
city: Santa Rosa de Viterbo
country: Colombia
facility: Empresa Social del Estado Hospital Regional de Duitama- Santa Rosa de Viterbo Branch
state: Boyaca
city: Guatavita
country: Colombia
facility: ESE Hospital San Antonio de Guatavita
state: Cundinamarca
city: Soacha
country: Colombia
facility: Hospital Mario Gaitán Yanguas
state: Cundinamarca
city: Guayabal
country: Colombia
facility: Empresa Social del Estado Hospital Nelson Restrepo Martinez
state: Tolima
city: Bogotá
country: Colombia
facility: Javesalud
Study officials:
affiliation: Dartmouth College
name: Lisa A Marsch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Javeriana
name: Carlos Gomez-Restrepo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.