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Scaling Up Science-based Mental Health Interventions in Latin America

Scaling Up Science-based Mental Health Interventions in Latin America

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03392883
Acronym
DIADA
Enrollment
1348
Registered
2018-01-08
Start date
2018-02-13
Completion date
2021-08-31
Last updated
2022-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Problematic Alcohol Use

Keywords

Latin America, Depression, mHealth, Problematic Alcohol Use

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.

Interventions

BEHAVIORALLaddr

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.

Sponsors

Pontificia Universidad Javeriana
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Program Sustainability Assessment Tool (PSAT) Administrative StaffAt 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.
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer InstrumentAt 6- and 12-month follow-up visits with a sub-sample of participantsThis 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 Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAt 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 InstrumentAt 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) ProvidersAt 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.

Secondary

MeasureTime frameDescription
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.
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).
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.

Other

MeasureTime frameDescription
Patient Utilization Interviews/ObservationsAt 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)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).
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).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.
COVID-19 Impact SurveyPatients 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.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.
Provider InterviewsAt 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)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.
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).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.
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).A measure used to assess problematic alcohol use. The Alcohol TLFB asks patients about their alcohol use in the past 30 days.
Behavioral Health Integration in Medical Care Index (BHIMC)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).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.
The Time-driven Activity-based Costing (TDABC) ApproachApproximately 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).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.
Non-Study Medical and Other Services (NSMOS)At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).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.
Non-Medical Expenses for Depression (NMED)At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).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.
Health and Work Performance Questionnaire (HPQ)At baseline, 6-month follow-ups, and 12-month follow-ups (for a total of 3 assessment timepoints per patient).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).
Administrative InterviewsAt 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)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.

Countries

Colombia

Participant flow

Recruitment details

At the primary care site patients upon arrival were asked to complete screeners (for depression and problematic alcohol use). In the event of positive screen for depression and/or alcohol use problems, clinicians at site completed an in-depth diagnostic interview. Participants who met all inclusionary criteria were informed about this project and provided an informed consent form. Providers and administrators who worked for the site for at least 3 months were asked to participate.

Participants by arm

ArmCount
Patients in Digital Health Assisted Mental Healthcare Intervention
Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool. 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. The program secondarily focused on problematic alcohol use and its relationship to depression management.
1,264
Providers in Digital Health Assisted Mental Healthcare Intervention
Providers at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
45
Administrative Staff in Digital Health Assisted Mental Healthcare Intervention
Administrative staff at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter.
39
Total1,348

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event100
Overall StudyDeath400
Overall StudyLack of Efficacy2900
Overall StudyLost to Follow-up122139
Overall StudyWithdrawal by Subject18000

Baseline characteristics

CharacteristicTotalAdministrative Staff in Digital Health Assisted Mental Healthcare InterventionProviders in Digital Health Assisted Mental Healthcare InterventionPatients in Digital Health Assisted Mental Healthcare Intervention
Age, Continuous48.88 years
STANDARD_DEVIATION 17.34
36.39 years
STANDARD_DEVIATION 12.51
32.87 years
STANDARD_DEVIATION 10.12
49.60 years
STANDARD_DEVIATION 17.28
Alcoholics Anonymous
No
1252 Participants0 Participants0 Participants1252 Participants
Alcoholics Anonymous
Prefers not to respond
0 Participants0 Participants0 Participants0 Participants
Alcoholics Anonymous
Yes
12 Participants0 Participants0 Participants12 Participants
Antidepressants Use
No
1075 Participants0 Participants0 Participants1075 Participants
Antidepressants Use
Prefers not to respond
2 Participants0 Participants0 Participants2 Participants
Antidepressants Use
Yes
187 Participants0 Participants0 Participants187 Participants
Education Level
At least one year in two-year university program
21 Participants0 Participants0 Participants21 Participants
Education Level
At least three years in four-year university program
36 Participants1 Participants0 Participants35 Participants
Education Level
Diploma
4 Participants0 Participants0 Participants4 Participants
Education Level
Doctorate
1 Participants0 Participants0 Participants1 Participants
Education Level
Grade 1
64 Participants0 Participants0 Participants64 Participants
Education Level
Grade 10
17 Participants0 Participants0 Participants17 Participants
Education Level
Grade 11
21 Participants0 Participants0 Participants21 Participants
Education Level
Grade 2
71 Participants0 Participants0 Participants71 Participants
Education Level
Grade 3
72 Participants0 Participants0 Participants72 Participants
Education Level
Grade 4
47 Participants0 Participants0 Participants47 Participants
Education Level
Grade 5
178 Participants0 Participants0 Participants178 Participants
Education Level
Grade 6
36 Participants0 Participants0 Participants36 Participants
Education Level
Grade 7
43 Participants0 Participants0 Participants43 Participants
Education Level
Grade 8
31 Participants0 Participants0 Participants31 Participants
Education Level
Grade 9
40 Participants0 Participants0 Participants40 Participants
Education Level
Kindergarten
0 Participants0 Participants0 Participants0 Participants
Education Level
Less than one year of university
19 Participants1 Participants0 Participants18 Participants
Education Level
Master's Degree
43 Participants12 Participants13 Participants18 Participants
Education Level
None
34 Participants0 Participants0 Participants34 Participants
Education Level
One year in four-year university program
13 Participants0 Participants0 Participants13 Participants
Education Level
Preschool
1 Participants0 Participants0 Participants1 Participants
Education Level
Professional Degree
177 Participants14 Participants28 Participants135 Participants
Education Level
Secondary Education Diploma
199 Participants1 Participants0 Participants198 Participants
Education Level
Technical Studies
160 Participants9 Participants2 Participants149 Participants
Education Level
Two years in four-year university program
9 Participants0 Participants0 Participants9 Participants
Education Level
University Degree
11 Participants1 Participants2 Participants8 Participants
Education Level
Unknown or prefers not to respond
0 Participants0 Participants0 Participants0 Participants
Employment Status
Full-time Employed
171 Participants0 Participants0 Participants171 Participants
Employment Status
Housekeeper
428 Participants0 Participants0 Participants428 Participants
Employment Status
Part-time Employed
49 Participants0 Participants0 Participants49 Participants
Employment Status
Pensioner
75 Participants0 Participants0 Participants75 Participants
Employment Status
Prefers not to respond
9 Participants0 Participants0 Participants9 Participants
Employment Status
Self-employed
286 Participants0 Participants0 Participants286 Participants
Employment Status
Student
70 Participants0 Participants0 Participants70 Participants
Employment Status
Unable to work
25 Participants0 Participants0 Participants25 Participants
Employment Status
Unemployed, not seeking jobs
39 Participants0 Participants0 Participants39 Participants
Employment Status
Unemployed, seeking jobs
112 Participants0 Participants0 Participants112 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1067 Participants34 Participants42 Participants991 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants1 Participants0 Participants20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
260 Participants4 Participants3 Participants253 Participants
Family History of Depression
First degree relatives with depression
132 Participants0 Participants0 Participants132 Participants
Family History of Depression
No family history of depression
764 Participants0 Participants0 Participants764 Participants
Family History of Depression
Parents with depression
163 Participants0 Participants0 Participants163 Participants
Family History of Depression
Prefers not to respond
156 Participants0 Participants0 Participants156 Participants
Family History of Depression
Siblings with depression
133 Participants0 Participants0 Participants133 Participants
Family History of Harmful Alcohol Use
First degree relatives with harmful alcohol use
367 Participants0 Participants0 Participants367 Participants
Family History of Harmful Alcohol Use
No family history of harmful alcohol use
605 Participants0 Participants0 Participants605 Participants
Family History of Harmful Alcohol Use
Parents with harmful alcohol use
473 Participants0 Participants0 Participants473 Participants
Family History of Harmful Alcohol Use
Prefers not to respond
18 Participants0 Participants0 Participants18 Participants
Family History of Harmful Alcohol Use
Siblings with harmful alcohol use
356 Participants0 Participants0 Participants356 Participants
Health Insurance Status
Contributory plan (EPS)
413 Participants0 Participants0 Participants413 Participants
Health Insurance Status
Indigenous Health plan
0 Participants0 Participants0 Participants0 Participants
Health Insurance Status
No insurance
1 Participants0 Participants0 Participants1 Participants
Health Insurance Status
Prefers not to respond
1 Participants0 Participants0 Participants1 Participants
Health Insurance Status
Special plan (Armed Forces, Ecopetrol)
0 Participants0 Participants0 Participants0 Participants
Health Insurance Status
Subsidized plan (ARS, SISBEN, EPS-S)
845 Participants0 Participants0 Participants845 Participants
Health Insurance Status
Supplemental plan or prepaid medical plan
4 Participants0 Participants0 Participants4 Participants
History of previous depressive episodes
0 episodes
890 Participants0 Participants0 Participants890 Participants
History of previous depressive episodes
1 episode
225 Participants0 Participants0 Participants225 Participants
History of previous depressive episodes
2 episodes
70 Participants0 Participants0 Participants70 Participants
History of previous depressive episodes
3 episodes
71 Participants0 Participants0 Participants71 Participants
History of previous depressive episodes
Prefers not to respond
8 Participants0 Participants0 Participants8 Participants
History of Traumatic Events
1
372 Participants0 Participants0 Participants372 Participants
History of Traumatic Events
10
6 Participants0 Participants0 Participants6 Participants
History of Traumatic Events
2
199 Participants0 Participants0 Participants199 Participants
History of Traumatic Events
3
83 Participants0 Participants0 Participants83 Participants
History of Traumatic Events
4
37 Participants0 Participants0 Participants37 Participants
History of Traumatic Events
5
24 Participants0 Participants0 Participants24 Participants
History of Traumatic Events
6
10 Participants0 Participants0 Participants10 Participants
History of Traumatic Events
7
1 Participants0 Participants0 Participants1 Participants
History of Traumatic Events
9
1 Participants0 Participants0 Participants1 Participants
History of Traumatic Events
No traumatic events
500 Participants0 Participants0 Participants500 Participants
History of Traumatic Events
Prefers not to respond
31 Participants0 Participants0 Participants31 Participants
Internet Use
No, does not use the Internet
421 Participants0 Participants0 Participants421 Participants
Internet Use
Yes, uses the Internet
843 Participants0 Participants0 Participants843 Participants
Length of time to reach healthcare center
0-29 minutes
631 Participants0 Participants0 Participants631 Participants
Length of time to reach healthcare center
30-59 minutes
464 Participants0 Participants0 Participants464 Participants
Length of time to reach healthcare center
60-120 minutes
134 Participants0 Participants0 Participants134 Participants
Length of time to reach healthcare center
More than 120 minutes
34 Participants0 Participants0 Participants34 Participants
Length of time to reach healthcare center
Prefers not to respond
1 Participants0 Participants0 Participants1 Participants
Marital Status
Divorced
36 Participants0 Participants0 Participants36 Participants
Marital Status
Married or Free Union
544 Participants0 Participants0 Participants544 Participants
Marital Status
Prefers not to respond
6 Participants0 Participants0 Participants6 Participants
Marital Status
Separated
172 Participants0 Participants0 Participants172 Participants
Marital Status
Single
399 Participants0 Participants0 Participants399 Participants
Marital Status
Widowed
107 Participants0 Participants0 Participants107 Participants
Medication for controlling problematic alcohol use
No
1262 Participants0 Participants0 Participants1262 Participants
Medication for controlling problematic alcohol use
Prefers not to respond
0 Participants0 Participants0 Participants0 Participants
Medication for controlling problematic alcohol use
Yes
2 Participants0 Participants0 Participants2 Participants
Name of Primary Care Center Site
Hospital Armero Guayabal
14 Participants3 Participants2 Participants9 Participants
Name of Primary Care Center Site
Hospital de Chaparral
84 Participants3 Participants3 Participants78 Participants
Name of Primary Care Center Site
Hospital Granja de Lerida
41 Participants9 Participants5 Participants27 Participants
Name of Primary Care Center Site
Hospital Regional de Duitama
491 Participants6 Participants14 Participants471 Participants
Name of Primary Care Center Site
Hospital Santa Rosa de Viterbo
210 Participants6 Participants8 Participants196 Participants
Name of Primary Care Center Site
Javesalud - Bogota
508 Participants12 Participants13 Participants483 Participants
Name of Primary Care Center Site
Prefer not to respond
0 Participants0 Participants0 Participants0 Participants
Number of persons in household
0
130 Participants0 Participants0 Participants130 Participants
Number of persons in household
1
312 Participants0 Participants0 Participants312 Participants
Number of persons in household
10
1 Participants0 Participants0 Participants1 Participants
Number of persons in household
11
2 Participants0 Participants0 Participants2 Participants
Number of persons in household
12
1 Participants0 Participants0 Participants1 Participants
Number of persons in household
14
2 Participants0 Participants0 Participants2 Participants
Number of persons in household
2
277 Participants0 Participants0 Participants277 Participants
Number of persons in household
3
253 Participants0 Participants0 Participants253 Participants
Number of persons in household
4
148 Participants0 Participants0 Participants148 Participants
Number of persons in household
5
77 Participants0 Participants0 Participants77 Participants
Number of persons in household
6
33 Participants0 Participants0 Participants33 Participants
Number of persons in household
7
16 Participants0 Participants0 Participants16 Participants
Number of persons in household
8
8 Participants0 Participants0 Participants8 Participants
Number of persons in household
9
4 Participants0 Participants0 Participants4 Participants
Psychotherapy Treatment Use
No
1048 Participants0 Participants0 Participants1048 Participants
Psychotherapy Treatment Use
Prefers not to respond
3 Participants0 Participants0 Participants3 Participants
Psychotherapy Treatment Use
Yes
213 Participants0 Participants0 Participants213 Participants
Race (NIH/OMB)
American Indian or Alaska Native
24 Participants1 Participants0 Participants23 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants0 Participants0 Participants10 Participants
Race (NIH/OMB)
More than one race
726 Participants23 Participants22 Participants681 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
340 Participants8 Participants14 Participants318 Participants
Race (NIH/OMB)
White
248 Participants7 Participants9 Participants232 Participants
Region of Enrollment
Colombia
1348 participants39 participants45 participants1264 participants
Sex: Female, Male
Female
1026 Participants27 Participants30 Participants969 Participants
Sex: Female, Male
Male
322 Participants12 Participants15 Participants295 Participants
Smartphone Use
No - does not have a smartphone
382 Participants0 Participants0 Participants382 Participants
Smartphone Use
Yes - has a smartphone.
882 Participants0 Participants0 Participants882 Participants
Socioeconomic Status
Prefers not to respond
14 Participants0 Participants0 Participants14 Participants
Socioeconomic Status
Rural Area
168 Participants0 Participants0 Participants168 Participants
Socioeconomic Status
Stratum 1
300 Participants0 Participants0 Participants300 Participants
Socioeconomic Status
Stratum 2
316 Participants0 Participants0 Participants316 Participants
Socioeconomic Status
Stratum 3
272 Participants0 Participants0 Participants272 Participants
Socioeconomic Status
Stratum 4
152 Participants0 Participants0 Participants152 Participants
Socioeconomic Status
Stratum 5
33 Participants0 Participants0 Participants33 Participants
Socioeconomic Status
Stratum 6
9 Participants0 Participants0 Participants9 Participants
Substance Use
Cannabis
53 Participants0 Participants0 Participants53 Participants
Substance Use
Cocaine
7 Participants0 Participants0 Participants7 Participants
Substance Use
Hallucinogens
5 Participants0 Participants0 Participants5 Participants
Substance Use
Methamphetamine
1 Participants0 Participants0 Participants1 Participants
Substance Use
Prescription Opioids
1 Participants0 Participants0 Participants1 Participants
Substance Use
Prescription Stimulants
2 Participants0 Participants0 Participants2 Participants
Substance Use
Sedatives
1 Participants0 Participants0 Participants1 Participants
Substance Use
Street Opioids
0 Participants0 Participants0 Participants0 Participants
Substance Use
Tobacco
163 Participants0 Participants0 Participants163 Participants
Tobacco Use
Current smoker
163 Participants0 Participants0 Participants163 Participants
Tobacco Use
Former smoker
414 Participants0 Participants0 Participants414 Participants
Tobacco Use
Never smoked
686 Participants0 Participants0 Participants686 Participants
Tobacco Use
Prefers not to respond
1 Participants0 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
7 / 1,264
other
Total, other adverse events
615 / 1,264
serious
Total, serious adverse events
107 / 1,264

Outcome results

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).

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

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument6-month follow-up Adoption2.76 score on a scaleStandard Deviation 0.58
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument6-month follow-up Acceptability3.22 score on a scaleStandard Deviation 0.64
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument6-month follow-up Appropriateness3.21 score on a scaleStandard Deviation 0.64
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument6-month follow-up Feasibility2.91 score on a scaleStandard Deviation 0.62
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument6-month follow-up Reach/Access2.59 score on a scaleStandard Deviation 0.69
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument12-month follow-up Adoption3.05 score on a scaleStandard Deviation 0.62
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument12-month follow-up Acceptability3.27 score on a scaleStandard Deviation 0.61
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument12-month follow-up Appropriateness3.28 score on a scaleStandard Deviation 0.5
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument12-month follow-up Feasibility2.93 score on a scaleStandard Deviation 0.54
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument12-month follow-up Reach/Access2.67 score on a scaleStandard Deviation 0.66
Comparison: We analyzed changes over time for every subscale. This Statistical Analysis describes the Adoption subscale results.p-value: <0.001t-test, 2 sided
Comparison: We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Acceptability subscale results.p-value: 0.552t-test, 2 sided
Comparison: We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Appropriateness subscale results.p-value: 0.32t-test, 2 sided
Comparison: We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Feasibility subscale results.p-value: 0.879t-test, 2 sided
Comparison: We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Reach/Access subscale results.p-value: 0.242t-test, 2 sided
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).

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

Population: The study implementation timeline was designed to have staggered launch dates for the six sites. Specifically, Javesalud (Site 1) and Santa Rosa (Site 2) launched first and were able to complete all follow-ups. Tundama (Site 3) was only able to complete through 18-month follow-ups. Guasca (Site 4) and Armero (Site 5) were only able to complete through 12-month follow-ups. Soacha (Site 6) was only able to complete through the 6-month follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentFeasibility at Baseline2.88 score on a scaleStandard Deviation 0.6
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentFeasibility at 6 months3.17 score on a scaleStandard Deviation 0.52
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentFeasibility at 12 months2.96 score on a scaleStandard Deviation 0.55
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentFeasibility at 18 months3.20 score on a scaleStandard Deviation 0.49
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentFeasibility at 24 months3.17 score on a scaleStandard Deviation 0.59
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentReach/Access at Baseline2.93 score on a scaleStandard Deviation 0.58
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentReach/Access at 6 months3.41 score on a scaleStandard Deviation 0.62
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentReach/Access at 12 months3.47 score on a scaleStandard Deviation 0.54
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentReach/Access at 18 months3.70 score on a scaleStandard Deviation 0.35
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentReach/Access at 24 months3.58 score on a scaleStandard Deviation 0.27
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentOrganizational Climate at Baseline3.39 score on a scaleStandard Deviation 0.43
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentOrganizational Climate at 6 months3.20 score on a scaleStandard Deviation 0.77
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentOrganizational Climate at 12 months3.22 score on a scaleStandard Deviation 0.63
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentOrganizational Climate at 18 months3.52 score on a scaleStandard Deviation 0.64
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentOrganizational Climate at 24 months3.47 score on a scaleStandard Deviation 0.48
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentLeadership in Implementing at Baseline3.29 score on a scaleStandard Deviation 0.69
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentLeadership in Implementing at 6 months3.17 score on a scaleStandard Deviation 0.78
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentLeadership in Implementing at 12 months3.25 score on a scaleStandard Deviation 0.8
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentLeadership in Implementing at 18 months3.65 score on a scaleStandard Deviation 0.37
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentLeadership in Implementing at 24 months3.47 score on a scaleStandard Deviation 0.45
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentGeneral Leadership Skills at Baseline3.34 score on a scaleStandard Deviation 0.56
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentGeneral Leadership Skills at 6 months2.42 score on a scaleStandard Deviation 1.02
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentGeneral Leadership Skills at 12 months2.92 score on a scaleStandard Deviation 0.81
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentGeneral Leadership Skills at 18 months2.44 score on a scaleStandard Deviation 0.63
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentGeneral Leadership Skills at 24 months2.80 score on a scaleStandard Deviation 1.05
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentKnowledge at Baseline1.95 score on a scaleStandard Deviation 0.48
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentKnowledge at 6 months1.95 score on a scaleStandard Deviation 0.28
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentKnowledge at 12 months1.92 score on a scaleStandard Deviation 0.27
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentKnowledge at 18 months1.91 score on a scaleStandard Deviation 0.26
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentKnowledge at 24 months1.92 score on a scaleStandard Deviation 0.26
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAdoption at Baseline3.38 score on a scaleStandard Deviation 0.47
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAdoption at 6 months3.37 score on a scaleStandard Deviation 0.46
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAdoption at 12 months3.69 score on a scaleStandard Deviation 0.4
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAdoption at 18 months3.87 score on a scaleStandard Deviation 0.22
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAdoption at 24 months3.50 score on a scaleStandard Deviation 0.67
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAccessibility at Baseline3.77 score on a scaleStandard Deviation 0.37
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAccessibility at 6 months3.50 score on a scaleStandard Deviation 0.39
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAccessibility at 12 months3.50 score on a scaleStandard Deviation 0.42
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAccessibility at 18 months3.60 score on a scaleStandard Deviation 0.42
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAccessibility at 24 months3.39 score on a scaleStandard Deviation 0.55
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAppropriateness at Baseline3.54 score on a scaleStandard Deviation 0.37
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAppropriateness at 6 months2.77 score on a scaleStandard Deviation 0.89
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAppropriateness at 12 months2.99 score on a scaleStandard Deviation 0.55
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAppropriateness at 18 months3.19 score on a scaleStandard Deviation 0.53
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff InstrumentAppropriateness at 24 months3.07 score on a scaleStandard Deviation 0.55
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.p-value: 0.118Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.p-value: 0.896Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.p-value: 0.739Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.p-value: 0.724Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.p-value: 0.301Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.p-value: 0.034Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.p-value: 0.015Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.p-value: 0.081Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Knowledge subscale results.p-value: 0.79Regression, Linear
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).

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

Population: The study implementation timeline was designed to have staggered launch dates for the six sites. Specifically, Javesalud (Site 1) and Santa Rosa (Site 2) launched first and were able to complete all follow-ups. Tundama (Site 3) was only able to complete through 18-month follow-ups. Guasca (Site 4) and Armero (Site 5) were only able to complete through 12-month follow-ups. Soacha (Site 6) was only able to complete through the 6-month follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAdoption at Baseline2.95 score on a scaleStandard Deviation 0.55
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAdoption at 6 months2.65 score on a scaleStandard Deviation 0.61
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAdoption at 12 months2.93 score on a scaleStandard Deviation 0.43
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAdoption at 18 months2.92 score on a scaleStandard Deviation 0.51
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAdoption at 24 months2.85 score on a scaleStandard Deviation 0.68
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAccessibility at Baseline3.41 score on a scaleStandard Deviation 0.51
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAccessibility at 6 months3.35 score on a scaleStandard Deviation 0.45
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAccessibility at 12 months3.50 score on a scaleStandard Deviation 0.47
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAccessibility at 18 months3.55 score on a scaleStandard Deviation 0.32
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAccessibility at 24 months3.38 score on a scaleStandard Deviation 0.44
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAppropriateness at Baseline3.40 score on a scaleStandard Deviation 0.34
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAppropriateness at 6 months3.32 score on a scaleStandard Deviation 0.47
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAppropriateness at 12 months3.52 score on a scaleStandard Deviation 0.31
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAppropriateness at 18 months3.41 score on a scaleStandard Deviation 0.42
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentAppropriateness at 24 months3.16 score on a scaleStandard Deviation 0.48
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentFeasibility at Baseline2.94 score on a scaleStandard Deviation 0.55
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentFeasibility at 6 months2.88 score on a scaleStandard Deviation 0.38
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentFeasibility at 12 months2.72 score on a scaleStandard Deviation 0.4
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentFeasibility at 18 months3.01 score on a scaleStandard Deviation 0.31
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentFeasibility at 24 months2.84 score on a scaleStandard Deviation 0.63
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentResources at Baseline3.14 score on a scaleStandard Deviation 0.65
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentResources at 6 months3.08 score on a scaleStandard Deviation 0.42
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentResources at 12 months2.98 score on a scaleStandard Deviation 0.47
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentResources at 18 months3.17 score on a scaleStandard Deviation 0.44
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentResources at 24 months3.14 score on a scaleStandard Deviation 0.64
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentReach/Access at Baseline2.78 score on a scaleStandard Deviation 0.65
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentReach/Access at 6 months2.85 score on a scaleStandard Deviation 0.48
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentReach/Access at 12 months2.96 score on a scaleStandard Deviation 0.44
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentReach/Access at 18 months3.00 score on a scaleStandard Deviation 0.52
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentReach/Access at 24 months2.91 score on a scaleStandard Deviation 0.22
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentOrganizational Climate at Baseline3.42 score on a scaleStandard Deviation 0.44
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentOrganizational Climate at 6 months3.43 score on a scaleStandard Deviation 0.43
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentOrganizational Climate at 12 months3.56 score on a scaleStandard Deviation 0.3
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentOrganizational Climate at 18 months3.60 score on a scaleStandard Deviation 0.35
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentOrganizational Climate at 24 months3.43 score on a scaleStandard Deviation 0.61
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentLeadership in Implementing at Baseline3.38 score on a scaleStandard Deviation 0.65
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentLeadership in Implementing at 6 months3.24 score on a scaleStandard Deviation 0.64
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentLeadership in Implementing at 12 months3.46 score on a scaleStandard Deviation 0.41
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentLeadership in Implementing at 18 months3.57 score on a scaleStandard Deviation 0.44
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentLeadership in Implementing at 24 months3.06 score on a scaleStandard Deviation 0.86
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentGeneral Leadership Skills at Baseline3.32 score on a scaleStandard Deviation 0.67
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentGeneral Leadership Skills at 6 months3.36 score on a scaleStandard Deviation 0.55
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentGeneral Leadership Skills at 12 months3.48 score on a scaleStandard Deviation 0.45
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentGeneral Leadership Skills at 18 months3.48 score on a scaleStandard Deviation 0.5
Patients in Digital Health Assisted Mental Healthcare InterventionThe Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider InstrumentGeneral Leadership Skills at 24 months3.20 score on a scaleStandard Deviation 0.94
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.p-value: 0.237Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.p-value: 0.492Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.p-value: 0.285Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.p-value: 0.964Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Resources subscale results.p-value: 0.942Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Scope subscale results.p-value: 0.366Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.p-value: 0.021Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.p-value: 0.832Regression, Linear
Comparison: We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.p-value: 0.827Regression, Linear
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.

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

Population: The study implementation timeline was designed to have staggered launch dates for the six sites. For providers/staff, not all sites completed 18 and 24-month follow-up assessments. Also, baseline data was collected prior to site implementation launch. Some providers/administrators consented and provided data (at various follow-up times) after baseline implementation data collection took place at the sites.

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Administrative StaffBaseline overall2.72 score on a scaleStandard Deviation 0.58
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Administrative Staff6 months follow-up overall3.14 score on a scaleStandard Deviation 0.37
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Administrative Staff12 months follow-up overall3.23 score on a scaleStandard Deviation 0.27
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Administrative Staff18 months follow-up overall3.41 score on a scaleStandard Deviation 0.29
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Administrative Staff24 months follow-up overall3.32 score on a scaleStandard Deviation 0.32
Comparison: We analyzed changes in the overall scores over time in this data.p-value: 0.589Regression, Linear
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.

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

Population: The study implementation timeline was designed to have staggered launch dates for the six sites. For providers/staff, not all sites completed 18 and 24-month follow-up assessments. Also, baseline data is collected prior to site implementation launch. Some providers/administrators consented and provided data (at various follow-up times) after baseline implementation data collection took place at the sites.

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) ProvidersBaseline overall3.01 score on a scaleStandard Deviation 0.61
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Providers6 months follow-up overall2.91 score on a scaleStandard Deviation 0.63
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Providers12 months follow-up overall2.99 score on a scaleStandard Deviation 0.41
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Providers18 months follow-up overall3.01 score on a scaleStandard Deviation 0.51
Patients in Digital Health Assisted Mental Healthcare InterventionThe Program Sustainability Assessment Tool (PSAT) Providers24 months follow-up overall2.82 score on a scaleStandard Deviation 0.63
Comparison: We analyzed changes in the overall scores over time.p-value: 0.023Regression, Linear
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.

Time frame: 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).

Population: The number of participants analyzed differs at each assessment timepoint due to a number of participants who were unable to reach during the designated window of assessment and participants who actively withdrew from the study for various non-safety related reasons.

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare Intervention12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)Baseline Total Sum Score23.07 score on a scaleStandard Deviation 7.72
Patients in Digital Health Assisted Mental Healthcare Intervention12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)3-Month Total Sum Score19.55 score on a scaleStandard Deviation 7.3
Patients in Digital Health Assisted Mental Healthcare Intervention12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)6-Month Total Sum Score19.32 score on a scaleStandard Deviation 7.5
Patients in Digital Health Assisted Mental Healthcare Intervention12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)9-Month Total Sum Score18.87 score on a scaleStandard Deviation 6.98
Patients in Digital Health Assisted Mental Healthcare Intervention12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)12-Month Total Sum Score18.59 score on a scaleStandard Deviation 6.73
Comparison: We analyzed changes over time by calculating the mean difference of the total scores (sum of 12 items) at baseline assessment and at 12-month follow-up assessment.
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.

Time frame: 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).

Population: Number of participants analyzed differ at each assessment timepoint because some participants were unable to be reached during the designated window of follow-up and some participants withdrew from the study.

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare InterventionGeneral Anxiety Disorder Screener (GAD-7)12-Month3.34 score on a scaleStandard Deviation 3.69
Patients in Digital Health Assisted Mental Healthcare InterventionGeneral Anxiety Disorder Screener (GAD-7)Baseline9.11 score on a scaleStandard Deviation 5.43
Patients in Digital Health Assisted Mental Healthcare InterventionGeneral Anxiety Disorder Screener (GAD-7)3-Month5.21 score on a scaleStandard Deviation 4.65
Patients in Digital Health Assisted Mental Healthcare InterventionGeneral Anxiety Disorder Screener (GAD-7)6-Month4.63 score on a scaleStandard Deviation 4.35
Patients in Digital Health Assisted Mental Healthcare InterventionGeneral Anxiety Disorder Screener (GAD-7)9-Month4.05 score on a scaleStandard Deviation 3.97
Comparison: We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.
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.

Time frame: 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).

Population: Only patient participants with a depression diagnosis completed the PHQ assessment at all timepoints. The number of participants analyzed varies at each assessment timepoint due to participants unable to reach during the window of follow-up and participants who withdrew from the study.

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare InterventionPatient Health Questionnaire (PHQ-8)Baseline11.32 score on a scaleStandard Deviation 5.07
Patients in Digital Health Assisted Mental Healthcare InterventionPatient Health Questionnaire (PHQ-8)3-Month5.82 score on a scaleStandard Deviation 5.09
Patients in Digital Health Assisted Mental Healthcare InterventionPatient Health Questionnaire (PHQ-8)6-Month5.51 score on a scaleStandard Deviation 4.94
Patients in Digital Health Assisted Mental Healthcare InterventionPatient Health Questionnaire (PHQ-8)9-Month5.37 score on a scaleStandard Deviation 4.67
Patients in Digital Health Assisted Mental Healthcare InterventionPatient Health Questionnaire (PHQ-8)12-Month4.67 score on a scaleStandard Deviation 4.38
Comparison: We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.
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).

Time frame: 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).

Population: The overall number of participants is different from the overall number of the patients arm, because this assessment was only administered to patients diagnosed with alcohol use disorder. There are different numbers of participants analyzed at each timepoint due to a number of participants who were unable to be reached in the designated window of follow-up and who withdrew from the study.

ArmMeasureGroupValue (MEAN)Dispersion
Patients in Digital Health Assisted Mental Healthcare InterventionThe Quick Drinking Screen (QDS) (for Full Implementation Study Only)Baseline Standard Drinks per Week22.74 standard drinks per weekStandard Deviation 28.28
Patients in Digital Health Assisted Mental Healthcare InterventionThe Quick Drinking Screen (QDS) (for Full Implementation Study Only)3-Month Standard Drinks per Week35.20 standard drinks per weekStandard Deviation 96.14
Patients in Digital Health Assisted Mental Healthcare InterventionThe Quick Drinking Screen (QDS) (for Full Implementation Study Only)6-Month Standard Drinks per Week46.37 standard drinks per weekStandard Deviation 102
Patients in Digital Health Assisted Mental Healthcare InterventionThe Quick Drinking Screen (QDS) (for Full Implementation Study Only)9-Month Standard Drinks per Week38.11 standard drinks per weekStandard Deviation 80.02
Patients in Digital Health Assisted Mental Healthcare InterventionThe Quick Drinking Screen (QDS) (for Full Implementation Study Only)12-Month Standard Drinks per Week25.33 standard drinks per weekStandard Deviation 72.61
Comparison: We analyzed changes over time by calculating the mean difference of the number of standard drinks per week at baseline assessment and at 12-month follow-up assessment.
Other Pre-specified

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.

Time frame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)

Other Pre-specified

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.

Time frame: 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 Pre-specified

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.

Time frame: 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 Pre-specified

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.

Time frame: 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.

Other Pre-specified

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.

Time frame: 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 Pre-specified

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.

Time frame: 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 Pre-specified

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).

Time frame: At baseline, 6-month follow-ups, and 12-month follow-ups (for a total of 3 assessment timepoints per patient).

Other Pre-specified

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.

Time frame: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).

Other Pre-specified

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.

Time frame: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).

Other Pre-specified

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).

Time frame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)

Other Pre-specified

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.

Time frame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)

Other Pre-specified

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.

Time frame: 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).

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026