DepressionDIADANCT03392883

Scaling Up Science-based Mental Health Interventions in Latin America

A study testing Laddr in people with Depression and Problematic Alcohol Use, run by Dartmouth-Hitchcock Medical Center at 6 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression, Problematic Alcohol Use
What is being tested?: Laddr
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,348 participants
Where: 6 sitesColombia
Study dates: 13 Feb 2018to 31 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

-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)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Colombia6 sites

Javesalud
Bogotá
Salud de Tundama
Duitama, Departamento de Boyacá
ESE Hospital San Antonio de Guatavita
Guatavita, Cundinamarca
Empresa Social del Estado Hospital Nelson Restrepo Martinez
Guayabal, Tolima Department
Empresa Social del Estado Hospital Regional de Duitama- Santa Rosa de Viterbo Branch
Santa Rosa de Viterbo, Departamento de Boyacá
Hospital Mario Gaitán Yanguas
Soacha, Cundinamarca, Colombia

Other trials in Colombia

About this study

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.

Read the 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.

Conditions: Depression, Problematic Alcohol Use
Being tested: Laddr
Keywords: Latin America, Depression, mHealth, Problematic Alcohol Use
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LaddrBehavioural
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.

Study groups in NCT03392883
Study group	Role	What they receive
Digital Health Assisted Mental Healthcare	Experimental	This Digital Health Assisted Mental Healthcare intervention will be based on the novel mobile-based platform (Laddr® from Square2 Systems). Receives: Behavioral: Laddr

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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.
Measured: This patient measure were assessed at baseline and every 3 months thereafter for a period of 12 months (for a total of 5 assessment timepoints per patient).
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
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.
Measured: This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints-level assessments per patient).
General Anxiety Disorder Screener (GAD-7)
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.
Measured: This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
The Quick Drinking Screen (QDS) (for Full Implementation Study Only)
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).
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 201831 Aug 2021

First posted8 Jan 2018
Study start13 Feb 2018
Primary completion18 Mar 2021
Study completion31 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 1,348 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03392883
Sponsor's protocol ID: 1U19MH109988 D18019
Other IDs: 1U19MH109988
Acronym: DIADA
Status last verified: Oct 2022
First submitted: 30 Oct 2017
Last updated: 9 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The investigators agree to share all data in accordance with NIH's data sharing policy and in accordance with the specific data sharing requirements of this NIMH Cooperative Agreement funding mechanism. The investigators agree to cooperate with the NIMH program staff to provide timely, accurate, and complete data for purposes of monitoring the progress of research activities conducted within the proposed project. The investigators will also work with NIH program staff to promote broad availability of policies, practices, materials, tools and data generated by the proposed project activities. At the conclusion of this study, the investigators plan to make available a public use file of all related study data (stripped of all personal identifiers and suitable for use by other investigators). The investigators will make the dataset available in one or more several common formats (e.g., ascii tab delimited, SAS and SPSS).

Publications

Marsch LA, Gomez-Restrepo C, Bartels SM, Bell K, Camblor PM, Castro S, Cardenas Charry MP, Cepeda M, Cubillos L, John D, Jassir MP, Lemley SM, Suarez-Obando F, Torrey WC, Uribe JM, Williams MJ. Scaling Up Science-Based Care for Depression and Unhealthy Alcohol Use in Colombia: An Implementation Science Project. Psychiatr Serv. 2022 Feb 1;73(2):196-205. doi: 10.1176/appi.ps.202000041. Epub 2021 Aug 4.
PubMed 34347504

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Scaling Up Science-based Mental Health Interventions in Latin America
ClinicalTrials.gov ID: NCT03392883
Acronym / sponsor ID: DIADA / 1U19MH109988 D18019
Conditions: Depression, Problematic Alcohol Use
Keywords: Latin America, Depression, mHealth, Problematic Alcohol Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,348 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: Pontificia Universidad Javeriana, National Institute of Mental Health (NIMH)
Study start: 13 Feb 2018 (actual)
Primary completion: 18 Mar 2021 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 8 Jan 2018 (actual)
Results: Posted 17 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Digital Health Assisted Mental Healthcare	Experimental	Behavioral: LaddrThis Digital Health Assisted Mental Healthcare intervention will be based on the novel mobile-based platform (Laddr® from Square2 Systems).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Provider and administrative staff Inclusion Criteria:
Participant Inclusion Criteria:

Key exclusion criteria (5 listed)

-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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LaddrLaddr 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.	Behavioural	Digital Health Assisted Mental Healthcare

Primary outcome

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

4 secondary outcomes

Patient Health Questionnaire (PHQ-8)
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).
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
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).
General Anxiety Disorder Screener (GAD-7)
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).
The Quick Drinking Screen (QDS) (for Full Implementation Study Only)
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).

Results and safety

Results posted to the registry on 17 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients in Digital Health Assisted Mental Healthcare Intervention	1,264	928
Providers in Digital Health Assisted Mental Healthcare Intervention	45	32
Administrative Staff in Digital Health Assisted Mental Healthcare Intervention	39	30

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

Time frame: At 6- and 12-month follow-up visits with a sub-sample of participants. Mean (Standard Deviation). Unit: score on a scale

Measure	Patients in Digital Health Assisted Mental Healthcare Intervention n = 166
6-month follow-up Adoption	2.76 (0.58)
6-month follow-up Acceptability	3.22 (0.64)
6-month follow-up Appropriateness	3.21 (0.64)
6-month follow-up Feasibility	2.91 (0.62)
6-month follow-up Reach/Access	2.59 (0.69)
12-month follow-up Adoption	3.05 (0.62)
12-month follow-up Acceptability	3.27 (0.61)
12-month follow-up Appropriateness	3.28 (0.50)

Patients in Digital Health Assisted Mental Healthcare Intervention: p <0.001, t-test, 2 sided
Patients in Digital Health Assisted Mental Healthcare Intervention: p = 0.552, t-test, 2 sided
Patients in Digital Health Assisted Mental Healthcare Intervention: p = 0.320, t-test, 2 sided

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

Time frame: At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.. Mean (Standard Deviation). Unit: score on a scale

Measure	Providers in Digital Health Assisted Mental Healthcare Intervention n = 24
Adoption at Baseline	2.95 (0.55)
Adoption at 6 months	2.65 (0.61)
Adoption at 12 months	2.93 (0.43)
Adoption at 18 months	2.92 (0.51)
Adoption at 24 months	2.85 (0.68)
Accessibility at Baseline	3.41 (0.51)
Accessibility at 6 months	3.35 (0.45)
Accessibility at 12 months	3.50 (0.47)

Providers in Digital Health Assisted Mental Healthcare Intervention: p = 0.237, Regression, Linear
Providers in Digital Health Assisted Mental Healthcare Intervention: p = 0.492, Regression, Linear
Providers in Digital Health Assisted Mental Healthcare Intervention: p = 0.285, Regression, Linear

Population analysed: 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.

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

Time frame: At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.. Mean (Standard Deviation). Unit: score on a scale

Measure	Administrative Staff in Digital Health Assisted Mental Healthcare Intervention n = 27
Adoption at Baseline	3.38 (0.47)
Adoption at 6 months	3.37 (0.46)
Adoption at 12 months	3.69 (0.40)
Adoption at 18 months	3.87 (0.22)
Adoption at 24 months	3.50 (0.67)
Accessibility at Baseline	3.77 (0.37)
Accessibility at 6 months	3.50 (0.39)
Accessibility at 12 months	3.50 (0.42)

Administrative Staff in Digital Health Assisted Mental Healthcare Intervention: p = 0.118, Regression, Linear
Administrative Staff in Digital Health Assisted Mental Healthcare Intervention: p = 0.896, Regression, Linear
Administrative Staff in Digital Health Assisted Mental Healthcare Intervention: p = 0.739, Regression, Linear

Primary outcome: The Program Sustainability Assessment Tool (PSAT) Providers

Time frame: At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.. Mean (Standard Deviation). Unit: score on a scale

Measure	Providers in Digital Health Assisted Mental Healthcare Intervention n = 41
Baseline overall	3.01 (0.61)
6 months follow-up overall	2.91 (0.63)
12 months follow-up overall	2.99 (0.41)
18 months follow-up overall	3.01 (0.51)
24 months follow-up overall	2.82 (0.63)

Providers in Digital Health Assisted Mental Healthcare Intervention: p = 0.023, Regression, Linear

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months after baseline assessment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients in Digital Health Assisted Mental Healthcare Intervention	107 of 1,264 (8.5%)	615 of 1,264 (48.7%)	7 of 1,264

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34347504Marsch LA, Gomez-Restrepo C, Bartels SM, Bell K, Camblor PM, Castro S, Cardenas Charry MP, Cepeda M, Cubillos L, John D, Jassir MP, Lemley SM, Suarez-Obando F, Torrey WC, Uribe JM, Williams MJ. Scaling Up Science-Based Care for Depression and Unhealthy Alcohol Use in Colombia: An Implementation Science Project. Psychiatr Serv. 2022 Feb 1;73(2):196-205. doi: 10.1176/appi.ps.202000041. Epub 2021 Aug 4.
Individual participant dataSharing planned: Yes. The investigators agree to share all data in accordance with NIH's data sharing policy and in accordance with the specific data sharing requirements of this NIMH Cooperative Agreement funding mechanism. The investigators agree to cooperate with the NIMH program staff to provide timely, accurate, and complete data for purposes of monitoring the progress of research activities conducted within the proposed project. The investigators will also work with NIH program staff to promote broad availability of policies, practices, materials, tools and data generated by the proposed project activities. At the conclusion of this study, the investigators plan to make available a public use file of all related study data (stripped of all personal identifiers and suitable for use by other investigators). The investigators will make the dataset available in one or more several common formats (e.g., ascii tab delimited, SAS and SPSS).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa A Marsch, PhD principal investigator

Dartmouth College

Carlos Gomez-Restrepo, MD principal investigator

Pontificia Universidad Javeriana

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laddr in people with Depression and Problematic Alcohol Use, run by Dartmouth-Hitchcock Medical Center at 6 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument (time frame: At 6- and 12-month follow-up visits with a sub-sample of participants). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03392883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.