e-SMART/EST HIV Telehealth Intervention

Study Overview
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Brief Summary
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The goal of this project is to adapt an evidence-based, enhanced cognitive-behavioral stress management intervention (CSBM+) to target depression among older HIV-positive women in the Bronx, New York. The intervention, Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST), demonstrated effectiveness in numerous iterations over 15+ years, including trials with racially diverse HIV-positive women. To meet changing community needs including moving behavioral interventions to telehealth, we will pilot test e-SMART/EST, a teletherapy adaptation with peer support for HIV+ older women.

Detailed Description
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HIV-positive older women are a neglected, high-risk population for depression. Depression is the most common psychiatric comorbidity for people living with HIV (PLWH), with prevalence between 20-40% and up to 78% in some cohorts. It has associations with lower CD4 (cluster of differentiation 4 - a type of white blood cell) count, higher viral load, reduced medication adherence, and AIDS-related and all-cause mortality. Among older people living with HIV/AIDS (PLWHA), women are more likely than men to be depressed. Group teletherapy is an efficacious modality to target depression, including among PLWHA, with improved retention and acceptability. To harness these innovations to improve outcomes for HIV+ older women, we will incorporate community feedback to refine and test an online adaption of SMART/EST, an empirically validated cognitive-behavioral stress management/expressive supportive therapy (CBSM+). SMART/EST is effective with HIV+ women and will likely be translated online given the proliferation of cognitive-behavioral therapy (CBT) teletherapy groups. Results will inform secondary prevention with a growing generation of HIV+ older women. The original, in-person intervention is a 16-session, two-hour weekly group using CBSM+ to target depression, medication adherence, nutrition, physical activity, harm reduction, smoking, and safer sex. e-SMART/EST will be online, condensed to 8 weekly 1-hour sessions, and will target depression. The study has two phases. In Phase 1, we will obtain scientific, community and expert advice from 8 community peer, scientific, and clinical advisors to adapt existent protocols. In Phase 2, we will conduct a pragmatic single group pre-post trial with 10 participants recruited from Montefiore's Women's Interagency HIV Study (WIHS). e-SMART/EST will be facilitated on MyChart by a Psychologist (PsyD) with prior experience developing the intervention, and co-facilitated by a community peer and Healthy Aging Specialist with 25+ years of experience in HIV programming. Participants will complete pre- and post-test surveys, as well as provide feedback about feasibility, adaptability, and recommendations to improve the intervention. Statistical analyses include paired-samples t-tests and adaptability/feasibility tests, as well as measures of fidelity.

Official Title
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e-SMART/EST Telehealth Intervention to Reduce Depression in Older Women With HIV

Conditions
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Hiv, Depression

Intervention / Treatment
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* Behavioral: Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-positive Age 55+ Teletherapy access Depression in last 12 months. Fluent in English Exclusion Criteria: HIV-negative or HIV-unknown Younger than 55 years old Lack of depression in last 12 months Non-fluent in English Opioid use disorder in last 12 months Psychotic disorder in last 12 months.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This clinical trial involves a single treatment arm, consisting of 10 women enrolled in a pilot group. The group will meet weekly for 8 weeks. The intervention consists of cognitive-behavioral stress management/expressive supportive therapy (CBSM+) targeting depression among older women with HIV. The group will be co-facilitated by a Psychologist and a Peer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group<br>Intervention consists of a psychotherapy trial using cognitive-behavioral stress management/expressive supportive therapy to target depression among HIV-positive older women. Dosage: 8 sessions. Frequency: weekly. Duration: 8 weeks. | Behavioral: Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST)<br>* Cognitive-behavioral stress management/expressive supportive therapy (CBSM+) group targeting depression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in score from Baseline in Depression on 21-item Beck Depression Inventory (BDI) at Week 9 | The Beck Depression Inventory (BDI) is a validated, self-report 21-item scale assessing depression. Response options range from 0-3 for each item. Item scores are summed, with sum scores ranging from 0-63. Higher scores indicate more depression (i.e., worse outcome). Scale scores from 1-10 indicate: These ups and downs are considered normal; 11-16: Mild mood disturbance; 17-20: Borderline clinical depression; 21-30: Moderate depression; 31-40: Severe depression; over 40: Extreme depression. | Baseline and Week 9 | 
| Decrease in score from Baseline in Anxiety on 21-item Beck Anxiety Inventory (BAI) at Week 9 | The Beck Anxiety Inventory (BAI) is a validated, self-report 21-item scale assessing anxiety. Response options range from 0-3 for each item. Item scores are summed, with sum scores ranging from 0-63. Higher scores indicate more anxiety (i.e., worse outcome). Scale scores from 0-21 indicate: low anxiety; 22-35: moderate anxiety; 36 and above: potentially concerning levels of anxiety. | Baseline and Week 9 |