N/A
N=1,348
Scaling Up Science-based Mental Health Interventions in Latin America
Depression · Problematic Alcohol Use
Bottom Line
View on ClinicalTrials.gov: NCT03392883 ↗Enrolled (actual)
1,348
Serious AEs
8.5%
Results posted
May 2022
Primary outcome: Primary: The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument — 2.76; 3.22; 3.21; 2.91 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laddr (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument |
2.76; 3.22; 3.21; 2.91; 2.59; 3.05 | <0.001 sig |
| PRIMARY The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument |
2.95; 2.65; 2.93; 2.92; 2.85; 3.41 | 0.237 |
| PRIMARY The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument |
3.38; 3.37; 3.69; 3.87; 3.50; 3.77 | 0.118 |
| PRIMARY The Program Sustainability Assessment Tool (PSAT) Providers |
3.01; 2.91; 2.99; 3.01; 2.82 | 0.023 sig |
| PRIMARY The Program Sustainability Assessment Tool (PSAT) Administrative Staff |
2.72; 3.14; 3.23; 3.41; 3.32 | 0.589 |
| SECONDARY Patient Health Questionnaire (PHQ-8) |
11.32; 5.82; 5.51; 5.37; 4.67 | — |
| SECONDARY 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) |
23.07; 19.55; 19.32; 18.87; 18.59 | — |
| SECONDARY General Anxiety Disorder Screener (GAD-7) |
9.11; 5.21; 4.63; 4.05; 3.34 | — |
| SECONDARY The Quick Drinking Screen (QDS) (for Full Implementation Study Only) |
22.74; 35.20; 46.37; 38.11; 25.33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Provider and administrative staff Inclusion Criteria:
- Aged > 18 years
- Have worked for the study site for at least 3 months.
- Participant Inclusion Criteria:
- Aged > 18 years
- Patients at one of our collaborating primary care sites
- Screen positive for minor (score of 5-9), moderate (score of 10-14), moderately severe (score of 15-19) or severe (score of 20-27) depression on Patient Health Questionnaire (PHQ-9)62 and/or screen positive for problematic alcohol use on Alcohol Use Disorder Identification Test (AUDIT) developed by the World Health Organization (a score of 8 or more on 10-item AUDIT)63 and have a confirmed diagnosis of depression and/or alcohol use disorder based on clinical consultation at the primary care site
- Willing to provide informed consent to use mobile intervention and complete study assessments
Exclusion Criteria
-Participant Exclusion Criteria
- Diagnosis with co-occurring severe mental illness (e.g., schizophrenia, bipolar disorder, depression with psychotic features)
- Alcohol withdrawal symptoms that require higher level of care (e.g., emergency medical or inpatient treatment)
- Express suicidal intention. This assessment will be based on a combination of a patient's response on the PHQ-9 assessment followed by further assessment by a primary care clinician. The PHQ-9 measure will not be used solely to determine eligibility on this criterion. Persons who express suicidal intention will immediately be provided immediate crisis management in accordance with the crisis management protocol at the collaborating primary care site.
- Intoxicated or otherwise impaired at the time of assessment (rendering the individual incapable of informed consent)
Data sourced from ClinicalTrials.gov (NCT03392883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.