Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05278572
Study type Interventional
Source Albert Einstein College of Medicine
Contact
Status Completed
Phase N/A
Start date January 25, 2023
Completion date April 5, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A