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An Adaptive Intervention for Depression Among Latinos Living With HIV

NCT03668379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-21

Study results available
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Summary

This study will use a pilot sequential multiple assignment randomized trial (SMART) design to build an adaptive treatment strategy (ATS) for depression and engagement in HIV among Latinos living with HIV. The ATS is the sequencing of treatments, which are a behavioral activation therapy (BAT), a cognitive-behavioral therapy (CBT), and mobile health (mHealth) tool. The outcomes are to assess the feasibility of the SMART and ATS in the HIV care site and acceptability of the SMART and ATS to patients and clinic staff.

Conditions

Interventions

BEHAVIORAL

Augment w/mHealth

"Non-responders" to the first stage treatment of BAT alone may be re-randomized to this augmented intervention to receive text-message support in addition to the BAT intervention.

BEHAVIORAL

Maintenance

"Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.

BEHAVIORAL

Switch to CBT & mHealth

"Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.

BEHAVIORAL

Augment w/BAT & mHealth

"Non-responders" to the BAT \& mHealth intervention may be re-randomized to receive an additional "dose" of BAT \& mHealth in the form of an additional session of BAT.

Sponsors & Collaborators

Principal Investigators

  • John A Sauceda, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2022-08-28
Completion
2022-08-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03668379 on ClinicalTrials.gov