Scaling Up Science-based Mental Health Interventions in Latin America

NCT03392883 | Completed Results DMC

• 2 other identifiers: 1U19MH109988 D180191U19MH109988
• Study Type: interventional
• Target: 1,348
• Locations: 1 country
• Sites: 6

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.

Conditions

Depression; Problematic Alcohol Use

Keywords

Latin America; Depression; mHealth; Problematic Alcohol Use

Outcome Measures

Primary Outcomes (5)

• The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument

  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).

  At 6- and 12-month follow-up visits with a sub-sample of participants

• The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument

  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).

  At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.

• The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument

  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).

  At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.

• The Program Sustainability Assessment Tool (PSAT) Providers

  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.

  At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.

• The Program Sustainability Assessment Tool (PSAT) Administrative Staff

  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.

  At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.

Secondary Outcomes (4)

• 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).

• 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).

• 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 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).

Other Outcomes (12)

• EuroQOL Five Dimensions Questionnaire (EQ-5D) (Only for Pilot Participants)

  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).

• EuroQol Visual Analogue Scale (EQ-VAS) (Only for Pilot Participants)

  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).

• Alcohol Timeline Follow-back (Alcohol TLFB) (Only for Pilot Participants)

  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).

Study Arms (1)

Digital Health Assisted Mental Healthcare

EXPERIMENTAL

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

Behavioral: Laddr

Interventions

Laddr 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.

Digital Health Assisted Mental Healthcare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Pontificia Universidad Javeriana: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (6)

ESE Hospital San Antonio de Guatavita

Guatavita, Cundinamarca, Colombia

Location

Hospital Mario Gaitán Yanguas

Soacha, Cundinamarca, Colombia, Colombia

Location

Salud de Tundama

Duitama, Departamento de Boyacá, Colombia

Location

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

Santa Rosa de Viterbo, Departamento de Boyacá, Colombia

Location

Empresa Social del Estado Hospital Nelson Restrepo Martinez

Guayabal, Tolima Department, Colombia

Location

Javesalud

Bogotá, Colombia

Location

Related Publications (1)

• 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.

  PMID: 34347504 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

On March 23, 2020, our study staff paused participant recruitment and all face-to-face activities at all of our study's sites due to COVID-19 related safety concerns. The study has not recruited patient participants since that date. On May 15, 2020, the study implemented a remote consent process to allow study enrollment of eligible providers and administrators and a remote informed consent process to allow all participants to participate in the qualitative sub-study.

Results Point of Contact

• Title: Lisa A. Marsch, PhD
• Organization: Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College

Lisa.a.marsch@dartmouth.edu

603-646-7092

Study Officials

• Lisa A Marsch, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• Carlos Gomez-Restrepo, MD

  Pontificia Universidad Javeriana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Technology and Behavioral Health

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: January 8, 2018
• Study Start: February 13, 2018
• Primary Completion: March 18, 2021
• Study Completion: August 31, 2021
• Last Updated: November 9, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available at the conclusion of the study. The investigators agree to retain records for each completed study for a minimum of 3 years (or more if necessary) after study data lock. The investigators will also comply with all relevant Institutional Review Board(s) IRB(s) and other regulatory entities regarding data sharing and records retention.
• Access Criteria: Although the final dataset will be stripped of identifiers prior to release for sharing, the investigators will further assure participants' confidentiality with a data sharing agreement that stipulates that all data and associated documentation will only be available to users who declare: (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. The investigators understand that NIH has access to any and all data generated under the cooperative agreement and agree to provide a royalty-free, nonexclusive, and irrevocable license for the government to reproduce, publish, or otherwise use the material and data derived from research conducted under this cooperative agreement.

Locations

CO (6)