Clinical trial NCT05278572: e-SMART/EST HIV Telehealth Intervention
Official title: e-SMART/EST Telehealth Intervention to Reduce Depression in Older Women With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Depression
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decrease in score from Baseline in Depression on 21-item Beck Depression Inventory (BDI) at Week 9
timeFrame: Baseline and Week 9
measure: Decrease in score from Baseline in Anxiety on 21-item Beck Anxiety Inventory (BAI) at Week 9
timeFrame: Baseline and Week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine - Department of Psychiatry and Behavioral Sciences
state: New York
Study officials:
affiliation: Einstein-Rockefeller-City University of New York Center for AIDS Research
name: Harris Goldstein, MD
role: STUDY_DIRECTOR
References:
citation: Waldron EM, Burnett-Zeigler I, Wee V, Ng YW, Koenig LJ, Pederson AB, Tomaszewski E, Miller ES. Mental Health in Women Living With HIV: The Unique and Unmet Needs. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:2325958220985665. doi: 10.1177/2325958220985665.
citation: Jones DL, McPherson-Baker S, Lydston D, Camille J, Brondolo E, Tobin JN, Weiss SM. Efficacy of a group medication adherence intervention among HIV positive women: the SMART/EST Women's Project. AIDS Behav. 2007 Jan;11(1):79-86. doi: 10.1007/s10461-006-9165-8.
citation: Weiss SM, Tobin JN, Antoni M, Ironson G, Ishii M, Vaughn A, Cassells A, Jones D, Schneiderman N, Brondolo E, Laperriere A, Lopez M, Villar-Loubet O, Camille J, Kumar M, Page JB; SMART/EST Women's Project Team*. Enhancing the health of women living with HIV: the SMART/EST Women's Project. Int J Womens Health. 2011 Feb 15;3:63-77. doi: 10.2147/IJWH.S5947.
citation: Laperriere A, Ironson GH, Antoni MH, Pomm H, Jones D, Ishii M, Lydston D, Lawrence P, Grossman A, Brondolo E, Cassells A, Tobin JN, Schneiderman N, Weiss SM. Decreased depression up to one year following CBSM+ intervention in depressed women with AIDS: the smart/EST women's project. J Health Psychol. 2005 Mar;10(2):223-31. doi: 10.1177/1359105305049772.
citation: Ironson G, Weiss S, Lydston D, Ishii M, Jones D, Asthana D, Tobin J, Lechner S, Laperriere A, Schneiderman N, Antoni M. The impact of improved self-efficacy on HIV viral load and distress in culturally diverse women living with AIDS: the SMART/EST Women's Project. AIDS Care. 2005 Feb;17(2):222-36. doi: 10.1080/09540120512331326365.
citation: Segal-Isaacson CJ, Tobin JN, Weiss SM, Brondolo E, Vaughn A, Wang C, Camille J, Gousse Y, Ishii M, Jones D, Laperriere A, Lydston D, Schneiderman N, Ironson G. Improving dietary habits in disadvantaged women with HIV/AIDS: the SMART/EST women's project. AIDS Behav. 2006 Nov;10(6):659-70. doi: 10.1007/s10461-006-9115-5. Epub 2006 Jun 1.
citation: Weiss SM, Tobin JN, Lopez M, Simons H, Cook R, Jones DL. Translating an Evidence-Based Behavioral Intervention for Women Living with HIV into Clinical Practice: The SMART/EST Women's Program. Int J Behav Med. 2015 Jun;22(3):415-24. doi: 10.1007/s12529-014-9399-1.
citation: Jones DL, Lopez M, Simons H, Diaz-Gloster M, Tobin JN, Weiss SM. Translation of a comprehensive health behavior intervention for women living with HIV: the SMART/EST Women's Program. Transl Behav Med. 2013 Dec;3(4):416-25. doi: 10.1007/s13142-013-0213-4.
citation: Webel AR. Testing a peer-based symptom management intervention for women living with HIV/AIDS. AIDS Care. 2010 Sep;22(9):1029-40. doi: 10.1080/09540120903214389.