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DepressionLatino-SMARTNCT03668379

An Adaptive Intervention for Depression Among Latinos Living With HIV

A study testing Augment w/mHealth, Maintenance and Switch to CBT & mHealth in people with Depression, run by University of California, San Francisco at 1 site in United States.

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

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depression
What is being tested?
Augment w/mHealth, Maintenance and Switch to CBT & mHealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
26 Feb 2020to 28 Aug 2022
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • HIV positive
  • 18 years of age and older
  • Self identifies as Latino/Hispanic
  • Fluent in English or Spanish
  • Receives HIV care at study site clinic
  • Has a moderate depression severity score or higher (Patient Health Questionnaire-9 score >9; PHQ)
Show all 11Show fewer
  • Agrees to discuss depression, treatment preferences, and mobile health
  • Owns a mobile phone that can send/receive short-message service (SMS) text messages
  • Agrees to participate in the intervention that lasts three months
  • Agrees to have medical and clinical data abstracted one year after baseline
  • Able and willing to consent to participate

Who cannot join

  • Not HIV positive
  • Under 18 years of age
  • Does not self-identify as Latino/Hispanic
  • Not fluent in English or Spanish
  • Does not receive primary HIV care at the study site
  • Has a less than moderate depression severity score (Patient Health Questionnaire-9 score ≤9; PHQ)
Show all 11Show fewer
  • Does not agree to discuss depression, treatment preferences, and mobile health
  • Does not owns a mobile phone that can send/receive short-message service (SMS) text messages
  • Does not agree to participate in the intervention that lasts three months
  • Does not agree to have medical and clinical data abstracted one year after baseline
  • Not able and willing to consent to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ward 86 HIV Clinic, Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: An Adaptive Treatment Intervention for Depression and Engagement in HIV Care Among Latinos Living With HIV

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.

Read the detailed description

This project proposes to use a SMART to build an adaptive treatment strategy (ATS) that has a mobile health (mHealth) tool (text-messaging) to improve adherence to the treatments for depression. The treatments being tested are a behavioral activation therapy (BAT) and cognitive-behavioral therapy (CBT). The outcomes are feasibility of the SMART and ATS in the HIV care site and acceptability of the SMART and ATS to patients and clinic staff. To achieve the overall goal, there are two aims. Aim 1 uses qualitative research methods for the conduct of focus groups and individual interviews with HIV+ Latinos in both English and Spanish. The goal of Aim 1 is to tailor the intervention to the cultural and linguistic needs of Latinos and the organization needs of the HIV clinic study site, which informs Aim 2. Aim 1 is guided by the CDCs Map of Adaptation tailoring framework, which consist of three Action Steps. Action Step 1-3 are to better understand and document: 1) expressions for depression in Spanish and barriers to care, 2) language issues in detecting and reporting depressive symptoms, 3) cultural perspectives of how depression presents as a barrier to care, and 4) attitudes (i.e., cognitive and emotional evaluations) toward BAT and CBT, and text-message preference and confidentiality concerns to promote adherence to the intervention activities. Aim 2 is to build and test a pilot SMART for an ATS - a set of decision rules that uses detectable changes in patient health status to inform the next course of treatment. Successful completion of the proposed study will yield pilot data on the feasibility and acceptability of an ATS for depression integrated into HIV primary care at the University of California San Francisco - Zuckerberg San Francisco General Hospital.

Conditions
Depression
Being tested
Augment w/mHealth, Maintenance, Switch to CBT & mHealth, Augment w/BAT & mHealth
Keywords
Depression, HIV, Latinos, Sequential multiple assignment randomized trial designs, Mobile health, Cognitive-behavioral therapy
Medical subject headings
Depression

What participants receive

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

  • Augment w/mHealthBehavioural

    "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.

  • MaintenanceBehavioural

    "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.

  • Switch to CBT & mHealthBehavioural

    "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.

  • Augment w/BAT & mHealthBehavioural

    "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.

Study groups in NCT03668379
Study groupRoleWhat they receive
Behavioral Activation TherapyActive comparatorDuring 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.
Receives: Behavioral: Augment w/mHealth; Behavioral: Maintenance; Behavioral: Switch to CBT & mHealth
Behavioral Activation Therapy & mHealthExperimentalDuring 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.
Receives: Behavioral: Maintenance; Behavioral: Switch to CBT & mHealth; Behavioral: Augment w/BAT & mHealth

What is being measured

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

  1. Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS)

    This is one composite measure. Feasibility of the adaptive treatment strategy (ATS) will be measured to assess whether the ATS is appropriate for further testing, relevant and sustainable. Feasibility of the ATS will be reported as a composite score of the following measures taken at the end of the second-stage treatment:

    1. Total number of participants screened, eligible and enrolled;
    2. At least 80% of all BAT \& CBT sessions completed;
    3. 80% retention of participants across all "outcome groups".

    Measured: 4 months

  2. Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)

    This is one composite measure. Acceptability of the adaptive treatment strategy will be measured to determine the tolerability or appropriateness of the SMART intervention from the perspective of both participants and clinicians.Acceptability of the ATS will be reported as a composite score of the following measures taken at the end of the second-stage treatment:

    1. Greater than 90% adherence to the BAT \& CBT session schedule;
    2. Responsiveness to text-messages: a) >80% of all two-way messages replied back to study line during the set of blocked hours; b) >90% of participants reporting direct benefit from one-way text messages;
    3. Acceptability responses coded from post-intervention exit interview transcripts;
    4. Limited number of barriers to participation reported by participants in exit interviews;
    5. Responses to a brief survey (to be developed) assessing clinic staff acceptability of the intervention.

    Measured: 4 months

Secondary outcomes (4)

  1. Self-reported Adherence to Antiretroviral Therapy (ART)

    Self-reported adherence will be measured using the the visual analog scale (VAS), a 10-cm line on which participants indicate the percentage of doses (intervals of 10 percentage points indicated from 0% to 100%) of all HIV medications taken in the past 30 days (Amico et al., 2006). Higher percentage indicates greater adherence to HIV medications. This measure will be used for descriptive purposes.

    Measured: 12 months

  2. Viral Load

    Viral load measures the amount of HIV virus in the blood. Viral load data abstracted from patient medical records will act as a descriptive measure of HIV-related clinical outcomes. A detectable viral load is a measurement of the amount of HIV in the blood, and an indication that HIV is replicating in the body. Undetectable viral load means that there is not enough of the virus to be detected.

    Measured: 12 months

  3. Patient Health Questionnaire-9 (PHQ-9)

    Patient Health Questionnaire-9 is a self-report measure of depression with a range from 0-27, with higher score indicating greater severity of depression symptoms.

    Measured: 12 months

  4. Engagement in HIV Care

    Engagement in care will be measured utilizing the multidimensional index of engagement in HIV care, a 10-item unit-dimensional patient-centered scale that assesses provider, clinic, and patient-level characteristics associated with being engaged in HIV care. This measure will be used for descriptive purposes. Mean scores are the sum of all 10 items divided by 10 with a range of 1-5, and higher scores indicate better engagement in care.

    Measured: 12 months

Timeline

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

  1. First posted12 Sep 2018
  2. Study start26 Feb 2020
  3. Primary completion28 Aug 2022
  4. Study completion28 Aug 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
The study utilizes a Sequential Multiple Assignment Randomized Trial (SMART) design in order to guide a series of adaptive behavioral interventions. In a SMART, eligible participants will be randomized at baseline and assigned to "1st-stage treatments" consisting of either 1. Behavioral Activation Therapy (BAT) or 2. BAT \& mHealth. During the first stage treatment, Patient Health Questionnaire-9 (PHQ-9) scores will be collected. At the follow-up period, the PHQ-9 will provide a cutoff score to determine whether a participant showed a clinically meaningful response ("responder/non-responder") to the "1st stage treatment." "Responder" indicates that patients successfully responded to the 1st stage treatment and will continue the treatment in maintenance mode. "Non-responder" indicates that the patient did not respond to the 1st-stage treatment and are re-randomized to either an augmented or "switched" intervention.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03668379
Sponsor's protocol ID
K01MH113475
Other IDs
K01MH113475
Acronym
Latino-SMART
Status last verified
Oct 2024
First submitted
28 Aug 2018
Last updated
21 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pfeiffer PN, Bohnert KM, Zivin K, Yosef M, Valenstein M, Aikens JE, Piette JD. Mobile health monitoring to characterize depression symptom trajectories in primary care. J Affect Disord. 2015 Mar 15;174:281-6. doi: 10.1016/j.jad.2014.11.040. Epub 2014 Nov 28.

    PubMed 25527999

  • Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.

    PubMed 22438190

  • Hopko DR, Lejuez CW, Ruggiero KJ, Eifert GH. Contemporary behavioral activation treatments for depression: procedures, principles, and progress. Clin Psychol Rev. 2003 Oct;23(5):699-717. doi: 10.1016/s0272-7358(03)00070-9.

    PubMed 12971906

  • Safren SA, O'Cleirigh C, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009 Jan;28(1):1-10. doi: 10.1037/a0012715.

    PubMed 19210012

  • Christopoulos KA, Riley ED, Tulsky J, Carrico AW, Moskowitz JT, Wilson L, Coffin LS, Falahati V, Akerley J, Hilton JF. A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial. BMC Infect Dis. 2014 Dec 31;14:718. doi: 10.1186/s12879-014-0718-6.

    PubMed 25551175

  • Murphy SA, Lynch KG, Oslin D, McKay JR, TenHave T. Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend. 2007 May;88 Suppl 2(Suppl 2):S24-30. doi: 10.1016/j.drugalcdep.2006.09.008. Epub 2006 Oct 23.

    PubMed 17056207

  • Dimidjian S, Barrera M Jr, Martell C, Munoz RF, Lewinsohn PM. The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psychol. 2011;7:1-38. doi: 10.1146/annurev-clinpsy-032210-104535.

    PubMed 21275642

  • Simoni JM, Wiebe JS, Sauceda JA, Huh D, Sanchez G, Longoria V, Andres Bedoya C, Safren SA. A preliminary RCT of CBT-AD for adherence and depression among HIV-positive Latinos on the U.S.-Mexico border: the Nuevo Dia study. AIDS Behav. 2013 Oct;17(8):2816-29. doi: 10.1007/s10461-013-0538-5.

    PubMed 23812892

  • McKleroy VS, Galbraith JS, Cummings B, Jones P, Harshbarger C, Collins C, Gelaude D, Carey JW; ADAPT Team. Adapting evidence-based behavioral interventions for new settings and target populations. AIDS Educ Prev. 2006 Aug;18(4 Suppl A):59-73. doi: 10.1521/aeap.2006.18.supp.59.

    PubMed 16987089

Questions about this trial

What is this clinical trial studying?

A study testing Augment w/mHealth, Maintenance and Switch to CBT & mHealth in people with Depression, run by University of California, San Francisco at 1 site in United States.

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 11 inclusion and 11 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 21 Oct 2024). 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?

Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) (time frame: 4 months). The study lists 2 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 NCT03668379, which also lists 9 linked publications.

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 21 Oct 2024.

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