Scaling Up Science-based Mental Health Interventions in Latin America

Not Applicable

Completed

Conditions: Depression
Problematic Alcohol Use

Interventions: Behavioral: Laddr

Registration Number: NCT03392883

Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1348

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument	At 6- and 12-month follow-up visits with a sub-sample of participants	This measure consists of 5 scales: Adoption, Appropriateness, Acceptability, Feasibility, and Reach/Access. All four scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).
The Program Sustainability Assessment Tool (PSAT) Providers	At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.	This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, and Communications within the organization. All scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4.
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument	At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.	This measure consists of 8 scales: Adoption, Appropriateness, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, and General Leadership Skills. All eight scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument	At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.	This measure consists of 9 scales: 1) Adoption, Appropriateness, Acceptability, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, General Leadership Skills, and Knowledge. All nine scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).
The Program Sustainability Assessment Tool (PSAT) Administrative Staff	At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.	This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Funding Stability, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, Communications within the organization, and Communication with Government. All seven scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-8)	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).	A measure with 8 items used to assess depression. The total score of the scale ranges from 0 to 24, with 0 representing no significant depressive symptoms and 24 representing the most severe depressive symptoms.
General Anxiety Disorder Screener (GAD-7)	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).	The GAD-7 is a 7-item self-reported screening questionnaire that has been validated to assess for generalized anxiety disorder (GAD) in outpatient and primary care settings. The measure is scored from 0 to 21, with 0 meaning minimal anxiety and 21 meaning most severe anxiety.
The Quick Drinking Screen (QDS) (for Full Implementation Study Only)	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).	The Quick Drinking Screen (QDS) is a 3-item questionnaire which asks about average drinking habits over the last ninety days. The responses are used to calculate the number of standard drinks consumed per week. In this measure, a standard drink is defined as 1-12 oz. regular can or glass of beer, or 1-5 oz. glass of regular wine, or 1 ½ oz. of regular proof hard liquor or spirits. Patients with alcohol use disorder will be asked to complete this measure as part of the baseline assessment and at every 3 months follow-up (a total of 5 assessment timepoints).
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)	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).	The WHODAS 2.0 assesses health-related difficulties across six different domains of functioning (cognition, mobility, self-care, socializing, life activities, and participation) that are linked conceptually and operationally to the International Classification of Functioning, Disability and Health (ICF). The scores assigned to 12 items are - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5). The scores for the 12 items are summed into a total score ranging from 12 (least severe) to 50 (most severe). The last 3 items of the assessment collect the number of days the reported health-related difficulties impact the participants in the past 90 days.

Trial Locations

Locations (6): Salud de Tundama
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Duitama, Boyaca, Colombia
Hospital Mario Gaitán Yanguas
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Soacha, Cundinamarca, Colombia
Empresa Social del Estado Hospital Regional de Duitama- Santa Rosa de Viterbo Branch
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Santa Rosa de Viterbo, Boyaca, Colombia
Empresa Social del Estado Hospital Nelson Restrepo Martinez
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Guayabal, Tolima, Colombia
Javesalud
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Bogotá, Colombia
ESE Hospital San Antonio de Guatavita
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Guatavita, Cundinamarca, Colombia