Project neuroARTEMIS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-29

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder

NCT00316303

HIV Infections Schizophrenia Schizoaffective Disorder +3 more

COMPLETED PHASE2

Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)

NCT00453609

Schizophrenia Schizoaffective Disorder Bipolar Disorder +1 more

COMPLETED PHASE4

Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity

NCT02667015

Other (or Unknown) Substance Use Disorders

COMPLETED PHASE2

Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use

NCT06620900

Concussion, Mild Traumatic Brain Injury Brain Injury Traumatic Brain Injury +2 more

NOT_YET_RECRUITING NA

Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder

NCT00218725

Suicide, Attempted Substance-Related Disorders

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stimulant Use Human Immunodeficiency Virus (HIV) Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARTEMIS

Participants in this arm will receive the ARTEMIS intervention immediately following randomization.

Group Type ACTIVE_COMPARATOR

ARTEMIS

Intervention Type BEHAVIORAL

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.

Contingency management for Antiretroviral (ARV) adherence

Intervention Type BEHAVIORAL

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.

Waitlist Control (WLC)

Participants in the WLC arm will be offered the ARTEMIS intervention after the final (6-month) follow-up.

Group Type OTHER

Contingency management for Antiretroviral (ARV) adherence

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No