e-SMART/EST HIV Telehealth Intervention

Not Applicable

Completed

• Conditions: Hiv; Depression
• Interventions: Behavioral: Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST)

• Registration Number: NCT05278572
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-14
• Study Start: 2023-01-25
• Status Verified: 2023-04
• Primary Completion: 2023-04-05
• Study Completion: 2023-04-05
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• HIV-positive
• Age 55+
• Teletherapy access
• Depression in last 12 months.
• Fluent in English

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group	Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST)	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.

Primary Outcome Measures

Name	Time	Method
Decrease in score from Baseline in Depression on 21-item Beck Depression Inventory (BDI) at Week 9	Baseline and 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.
Decrease in score from Baseline in Anxiety on 21-item Beck Anxiety Inventory (BAI) at Week 9	Baseline and 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.

Trial Locations

Locations (1)

Albert Einstein College of Medicine - Department of Psychiatry and Behavioral Sciences; 🇺🇸 Bronx, New York, United States