An Adaptive Intervention for Depression Among Latinos Living With HIV

NCT03668379 | Completed Results

• 1 other identifier: K01MH113475
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Depression

Keywords

Depression; HIV; Latinos; Sequential multiple assignment randomized trial designs; Mobile health; Cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (2)

• 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".

  4 months

• 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.

  4 months

Secondary Outcomes (4)

• Self-reported Adherence to Antiretroviral Therapy (ART)

  12 months

• Viral Load

  12 months

• Patient Health Questionnaire-9 (PHQ-9)

  12 months

• Engagement in HIV Care

  12 months

Study Arms (2)

Behavioral Activation Therapy

ACTIVE COMPARATOR

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.

Behavioral: Augment w/mHealth; Behavioral: Maintenance; Behavioral: Switch to CBT & mHealth

Behavioral Activation Therapy & mHealth

EXPERIMENTAL

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.

Behavioral: Maintenance; Behavioral: Switch to CBT & mHealth; Behavioral: Augment w/BAT & mHealth

Interventions

Augment w/mHealth BEHAVIORAL

"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 Activation Therapy

Maintenance BEHAVIORAL

"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 Activation Therapy; Behavioral Activation Therapy & mHealth

Switch to CBT & mHealth BEHAVIORAL

"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 Activation Therapy; Behavioral Activation Therapy & mHealth

Augment w/BAT & mHealth BEHAVIORAL

"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.

Behavioral Activation Therapy & mHealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive
• 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)
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ward 86 HIV Clinic, Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (9)

• 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.

  PMID: 25527999 BACKGROUND

• 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.

  PMID: 22438190 BACKGROUND

• 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.

  PMID: 12971906 BACKGROUND

• 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.

  PMID: 19210012 BACKGROUND

• 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.

  PMID: 25551175 BACKGROUND

• 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.

  PMID: 17056207 BACKGROUND

• 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.

  PMID: 21275642 BACKGROUND

• 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.

  PMID: 23812892 BACKGROUND

• 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.

  PMID: 16987089 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Maintenance; Telemedicine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services; Delivery of Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

The trial was severely limited by COVID-19. The trial launched recruitment in late February 2020, and the University of California, San Francisco instituted a complete pausing of non-essential research in March of 2020. This was followed by ongoing pauses and delays with each new COVID-19 variants and corresponding restrictions, such as limited capacity of to engage with participants given social distancing policies on site. Each part of the trial was severely limited and negatively impacted.

Results Point of Contact

• Title: John Sauceda, PhD, Associate Professor
• Organization: University of California, San Francisco

john.sauceda@ucsf.edu

415-502-1000

Study Officials

• John A Sauceda, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Medical providers of the patients enrolled in the study will be notified that their patient is in a study for depression but not told what intervention arm. At all follow-up outcome points, the assessor will be blind to all intervention arms the patient were randomized to.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 12, 2018
• Study Start: February 26, 2020
• Primary Completion: August 28, 2022
• Study Completion: August 28, 2022
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)