e-SMART/EST HIV Telehealth Intervention (eSMARTEST)

A

Albert Einstein College of Medicine

Status

Completed

Conditions

Depression
Hiv

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05278572
2021-13391

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Female

Ages

55 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Group
Experimental group
Description:
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.
Treatment:
Behavioral: Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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