Scaling Up Science-based Mental Health Interventions in Latin America

Depression Clinical Trial

— DIADA  

Official title:

Scaling Up Science-based Mental Health Interventions in Latin America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392883
• Other study ID #: 1U19MH109988 D18019
• Secondary ID: 1U19MH109988
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2022
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1348
• Est. completion date: August 31, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Depression
• Problematic Alcohol Use

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Colombia	Javesalud	Bogotá
Colombia	Salud de Tundama	Duitama	Boyaca
Colombia	ESE Hospital San Antonio de Guatavita	Guatavita	Cundinamarca
Colombia	Empresa Social del Estado Hospital Nelson Restrepo Martinez	Guayabal	Tolima
Colombia	Empresa Social del Estado Hospital Regional de Duitama- Santa Rosa de Viterbo Branch	Santa Rosa de Viterbo	Boyaca
Colombia	Hospital Mario Gaitán Yanguas	Soacha	Cundinamarca

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute of Mental Health (NIMH), Pontificia Universidad Javeriana

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EuroQOL Five Dimensions Questionnaire (EQ-5D) (Only for Pilot Participants)	The EQ-5D. The EQ-5D is a standardized instrument that has been widely used and validated within Spanish speaking populations from several countries in Latin America, and assesses 5 key dimensions of health.	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).
Other	EuroQol Visual Analogue Scale (EQ-VAS) (Only for Pilot Participants)	The EQ-VAS assess health-related quality of life. The EQ-VAS asks "how good or bad your health is today?" The scale ranges from 0 (worst health imaginable) to 100 (best health imaginable). The participants marks their number with an "X" on the scale and writes it in a box.	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).
Other	Alcohol Timeline Follow-back (Alcohol TLFB) (Only for Pilot Participants)	A measure used to assess problematic alcohol use. The Alcohol TLFB asks patients about their alcohol use in the past 30 days.	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).
Other	Behavioral Health Integration in Medical Care Index (BHIMC)	The BHIMC is an organizational measure of the level of behavioral health integration in medical practice settings. It evaluates policy, clinical practice and workforce dimensions of integration using mixed methods, i.e. combination of document review and observation.	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).
Other	The Time-driven Activity-based Costing (TDABC) Approach	The TDABC method measures costs of implementing the proposed model of care for depression and alcohol use disorders.The TDABC method will be used to determine the costs of the specific human, equipment, and facility resources used for delivering mental health care to patients as part of the model of care.	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).
Other	Non-Study Medical and Other Services (NSMOS)	The NSOMS assesses patients' medical resource use that is not part of the intervention, including non-treatment therapy visits, physician visits, residential and/or hospital detoxification, hospital and emergency department visits, and medication use through patient self-report.	At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
Other	Non-Medical Expenses for Depression (NMED)	The NMED assesses the non-medical costs of depression. This measure is in Spanish and has been used in Latin America and used by our team at Javeriana.	At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
Other	Health and Work Performance Questionnaire (HPQ)	The HPQ was developed by the World Health Organization, and assess the impact of depression on work performance (including sickness absence, presenteeism, and critical incidents).	At baseline, 6-month follow-ups, and 12-month follow-ups (for a total of 3 assessment timepoints per patient).
Other	Administrative Interviews	Administrative interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels.	At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
Other	Patient Utilization Interviews/Observations	The investigators will recruit and follow a sample of patients (approx. 5 at each site) during the implementation project to explore feasibility issues regarding use, barriers and facilitating strategies for using the program, optimal dissemination strategies for promoting use of the program, and overall experiences using the program over time. These patient participants will be encouraged to document their experiences with the mental health service delivery model in an ongoing manner (e.g., note jotting, pictures, audio recording).	At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
Other	Provider Interviews	Provider interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels.	At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
Other	COVID-19 Impact Survey	The COVID-19 Impact Survey is a self-reported questionnaire developed by the NIMH U19 Scale-Up Hubs and will assess the impact of COVID-19 among patients, providers, and administrators enrolled in this study. Given the unknown and widespread implications of the COVID-19 pandemic in Colombia, it is critical to understand the context of COVID-19 for interpreting the study's findings.	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.
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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	Patient Health Questionnaire (PHQ-8)	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.	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).
Secondary	12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)	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.	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).
Secondary	General Anxiety Disorder Screener (GAD-7)	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.	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).
Secondary	The Quick Drinking Screen (QDS) (for Full Implementation Study Only)	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).	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).