Depression
Conditions
Keywords
Depression, HIV, Latinos, Sequential multiple assignment randomized trial designs, Mobile health, Cognitive-behavioral therapy
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.
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.
Interventions
BEHAVIORALAugment 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.
BEHAVIORALMaintenance
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.
BEHAVIORALSwitch 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.
BEHAVIORALAugment 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
National Institute of Mental Health (NIMH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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) * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) | 4 months | 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. |
| Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Adherence to Antiretroviral Therapy (ART) | 12 months | 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. |
| Viral Load | 12 months | 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. |
| Patient Health Questionnaire-9 (PHQ-9) | 12 months | 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. |
| Engagement in HIV Care | 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Activation Therapy 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 eight, 1-hour sessions will be delivered every two weeks.
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.
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.
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. | 5 |
| Behavioral Activation Therapy & mHealth 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.
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.
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.
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. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Total | Behavioral Activation Therapy & mHealth | Behavioral Activation Therapy |
|---|---|---|---|
| Age, Continuous | 47 Years STANDARD_DEVIATION 12.8 | 48.4 Years STANDARD_DEVIATION 14.5 | 45.6 Years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire-9 | 11.9 units on a scale STANDARD_DEVIATION 4.14 | 13.6 units on a scale STANDARD_DEVIATION 4.21 | 10.2 units on a scale STANDARD_DEVIATION 3.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 10 participants | 5 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 5 Participants |
| The Index of HIV Care Engagement-- or index of | 4.20 units on a scale STANDARD_DEVIATION 0.7 | 4.15 units on a scale STANDARD_DEVIATION 0.6 | 4.24 units on a scale STANDARD_DEVIATION 0.84 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
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.
Time frame: 4 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Activation Therapy Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | 90% Adherence | 3 Participants |
| Behavioral Activation Therapy Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | Two-Way Text-Message Response | 0 Participants |
| Behavioral Activation Therapy Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | One-Way Text-Message Response | 0 Participants |
| Behavioral Activation Therapy Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | Acceptability Responses | 0 Participants |
| Behavioral Activation Therapy Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | Barriers | 0 Participants |
| Behavioral Activation Therapy Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | Responses | 0 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | Barriers | 0 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | 90% Adherence | 1 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | Acceptability Responses | 0 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | Two-Way Text-Message Response | 0 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | Responses | 0 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) | One-Way Text-Message Response | 0 Participants |
Primary
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.
Time frame: 4 months
Population: In this study, all participants assigned to their 1st stage treatment either responded and entered the maintenance arm or did not complete the intervention. Thus, we had no non-responders and no re-randomized participants who would have either augmented or changed their 1st stage treatment. Results reflect this result and zero cells in the other arms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Activation Therapy Maintenance | Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) | Enrolled | 5 Participants |
| Behavioral Activation Therapy Maintenance | Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) | Completion Percentage | 4 Participants |
| Behavioral Activation Therapy Maintenance | Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) | Retention Percentage | 0 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) | Enrolled | 5 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) | Completion Percentage | 3 Participants |
| Behavioral Activation Therapy & mHealth Maintenance | Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) | Retention Percentage | 0 Participants |
Secondary
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.
Time frame: 12 months
Population: The disruptions of COVID-19 prevented us from collecting data 12-month survey data and thus, we have entered 0 into the cells as instructed.
Secondary
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.
Time frame: 12 months
Population: The disruptions of COVID-19 prevented us from collecting data 12-month survey data and thus, we have entered 0 into the cells as instructed.
Secondary
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.
Time frame: 12 months
Population: The disruptions of COVID-19 prevented us from collecting data 12-month survey data and thus, we have entered 0 into the cells as instructed.
Secondary
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.
Time frame: 12 months
Population: We could not abstract viral load data from 1 participant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Behavioral Activation Therapy Maintenance | Viral Load | Undetectable viral load | 3 participants |
| Behavioral Activation Therapy Maintenance | Viral Load | Detectable viral load | 1 participants |
| Behavioral Activation Therapy & mHealth Maintenance | Viral Load | Undetectable viral load | 4 participants |
| Behavioral Activation Therapy & mHealth Maintenance | Viral Load | Detectable viral load | 1 participants |