e-SMART/EST HIV Telehealth Intervention (eSMARTEST)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    10
  • sponsor
    Albert Einstein College of Medicine
Updated on 7 October 2022
behavior therapy
depressed mood

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.

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 preand 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.

Details
Condition Hiv, Depression
Treatment Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST)
Clinical Study IdentifierNCT05278572
SponsorAlbert Einstein College of Medicine
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note