Anxiety & Depression Association of America

Project neuroARTEMIS

Purpose

The purpose of this research is to understand how chronic stress affects the way our brain and immune systems function, and in turn how this affects the way people feel, think, and behave. By learning more about how these processes work, the hope is to be able to develop better treatments to help with problems like depression and substance use. This study is intended for individuals that are HIV positive, currently taking prescription antiretroviral medications, and use stimulants. Through this intervention, the aim is to determine if this positive affect intervention can lead to reductions in stimulant use and depressed mood.

Conditions

Stimulant Use
Human Immunodeficiency Virus (HIV)
Depression

Eligibility

Eligible Ages: Between 18 Years and 59 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

18-59 years old - Weekly use of stimulants reported in the past month or a score of 4 or more on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Confirmed HIV diagnosis - Current receipt of daily oral antiretroviral therapy (ART) medication - English fluency/literacy

Exclusion Criteria

Acute brain infection (e.g., neurosyphilis, toxoplasmosis) - Acutely symptomatic bipolar I or psychotic disorder - Prescription for immunomodulatory medications or other immunotherapy - Any MRI contraindications - If applicable, on antidepressant medication regimen for at least 2 months

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will utilize two treatment arms in which participants are randomized using a 2:1 allocation. Arm A will receive the ARTEMIS intervention immediately following their baseline visit. Arm B will be considered a wait-list control, being offered the ARTEMIS intervention after a 6-month delay.
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator ARTEMIS	Participants in this arm will receive the ARTEMIS intervention immediately following randomization.	Behavioral: ARTEMIS The ARTEMIS intervention includes 5 sessions delivered individually over Zoom across 3 months. The intervention teaches 9 positive affect skills: noting and capitalizing on positive events, gratitude journaling, formal and informal mindfulness, positive reappraisal and problem solving coping skills training, focusing on personal strengths, setting achievable goals, and small acts of kindness. Each session consists of a didactic portion with in vivo skills practice, and participants are asked to complete daily home practice of the skills between sessions. Behavioral: Contingency management for Antiretroviral (ARV) adherence All participants will received the contingency management (CM) intervention to support ARV adherence. They will use the Spotlight by Scene Health platform, a HIPAA-compliant mHealth application for directly observed therapy, to upload videos of ART adherence. The app records and uploads time-stamped videos of medication doses, which staff verify asynchronously. Participants will be paid for each verified dose and receive a weekly bonus if they complete 6 doses.
Other Waitlist Control (WLC)	Participants in the WLC arm will be offered the ARTEMIS intervention after the final (6-month) follow-up.	Behavioral: Contingency management for Antiretroviral (ARV) adherence All participants will received the contingency management (CM) intervention to support ARV adherence. They will use the Spotlight by Scene Health platform, a HIPAA-compliant mHealth application for directly observed therapy, to upload videos of ART adherence. The app records and uploads time-stamped videos of medication doses, which staff verify asynchronously. Participants will be paid for each verified dose and receive a weekly bonus if they complete 6 doses.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Wake Forest University Health Sciences

Study Contact

Christina S Meade, PhD
336-716-0695
cmeade@wakehealth.edu

Detailed Description

Participants who meet initial eligibility criteria will complete a baseline assessment that includes psychosocial and behavioral measures, biospecimen collection, and an MRI brain scan. Participants will then be randomized to either: 1) ARTEMIS; or 2) a waitlist control (WLC) condition. ARTEMIS participants will receive 5 sessions delivered individually over Zoom across 3 months. All participants (including WLC) will receive contingency management (CM) for antiretroviral therapy (ART) adherence to support sustained viral suppression over the active phase of the trial. During the intent-to-treat period, assessments at 3- and 6-month follow-ups will characterize changes in neural activity (assessed via fMRI) and conserved transcriptional response to adversity (CTRA) leukocyte signaling (assessed via RNA sequencing) as plausible mediators of behavioral outcomes following ARTEMIS. WLC participants will be offered the ARTEMIS intervention after a 6-month delay.