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Augment w/BAT & mHealth for Depression (Latino-SMART Trial)

N/A
Waitlist Available
Led By John A Sauceda, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Latino-SMART Trial Summary

This study is evaluating whether a sequential treatment strategy may help improve depression and engagement in HIV care for Latinos living with HIV.

Eligible Conditions
  • Depression

Latino-SMART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite measure of acceptability for the adaptive treatment strategy (ATS)
Composite measure of feasibility for the adaptive treatment strategy (ATS)
Secondary outcome measures
Engagement in HIV Care
Patient Health Questionnaire-9 (PHQ-9)
Self-reported Adherence to Antiretroviral Therapy (ART)
+1 more

Latino-SMART Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Activation Therapy & mHealthExperimental Treatment3 Interventions
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
Group II: Behavioral Activation TherapyActive Control3 Interventions
During the initial stage treatment, the active comparator arm is the behavioral activation (BAT) program intervention. BAT is informed by behavioral theory and has been shown to be a highly efficacious treatment for depression. A total of five, 1-hour sessions will be delivered every two weeks. During Session 1, the focus will be on providing an introduction to BAT, as well as building "confianza" (mutual trust) between the patient and provider. Sessions 2 & 3 will review the initial session, introduce "high" value activities and barriers to BAT protocols. Sessions 4 & 5 will review progress, challenges & maintenance strategies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Augment w/BAT & mHealth
2020
N/A
~20
Maintenance
2002
Completed Phase 2
~530
Switch to CBT & mHealth
2020
N/A
~20

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,498 Previous Clinical Trials
11,936,335 Total Patients Enrolled
71 Trials studying Depression
28,815 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,780 Previous Clinical Trials
2,674,881 Total Patients Enrolled
665 Trials studying Depression
251,405 Patients Enrolled for Depression
John A Sauceda, PhDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Drug and Alcohol DependenceJournal
Developing Adaptive Treatment Strategies in Substance Abuse Research
Murphy, Susan A., Kevin G. Lynch, David Oslin, James R. McKay, and Tom TenHave. 2007. “Developing Adaptive Treatment Strategies in Substance Abuse Research”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/j.drugalcdep.2006.09.008.
Statistics in MedicineJournal
Designing a Pilot Sequential Multiple Assignment Randomized Trial for Developing an Adaptive Treatment Strategy
Almirall, Daniel, Scott N. Compton, Meredith Gunlicks-Stoessel, Naihua Duan, and Susan A. Murphy. 2012. “Designing a Pilot Sequential Multiple Assignment Randomized Trial for Developing an Adaptive Treatment Strategy”. Statistics in Medicine. Wiley. doi:10.1002/sim.4512.
clinicaltrials.govStudy
An Adaptive Intervention for Depression Among Latinos Living With HIV
2020. "An Adaptive Intervention for Depression Among Latinos Living With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03668379.
~3 spots leftby Apr 2025
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