ARTEMIS + Contingency Management for Depression

Overseen By Sheri L Towe, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Antiretrovirals

Must not be taking: Immunomodulatory, Antidepressants

Disqualifiers: Acute brain infection, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

189 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how chronic stress affects the brain and immune systems, potentially leading to conditions like depression and substance use issues. Researchers are testing a treatment called ARTEMIS, a new potential therapy, to determine if it can reduce stimulant use and improve mood in individuals who are HIV positive and currently on antiretroviral medications. The trial targets those who use stimulants weekly and can communicate easily in English. Participants will either begin the ARTEMIS treatment immediately or after a six-month wait. As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to new treatments for stress-related conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on antiretroviral therapy (ART) and excludes those on immunomodulatory medications or immunotherapy. If you are on antidepressants, you must have been on them for at least 2 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ARTEMIS, the treatment under study, is generally well-tolerated. It has been examined in various contexts, such as aiding individuals with depression and reducing mental health stigma. Although detailed safety information for ARTEMIS in this specific study is unavailable, the trial is labeled "Not Applicable" for its phase, indicating it may be in early testing stages, so direct safety evidence could be limited.

However, treatments entering clinical trials typically have some background information suggesting they might be safe enough for human testing. ARTEMIS has been used in other studies to address mental health issues, providing some reassurance about its safety. Participants are always closely monitored during trials for any side effects or adverse events. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for depression, which often includes medications like SSRIs and therapy, ARTEMIS is unique because it integrates technology with mental health treatment. This approach leverages digital tools to provide personalized feedback and support, which could lead to more engaging and accessible therapy options. Researchers are excited about ARTEMIS because it offers the potential for real-time monitoring and adaptive interventions, which might improve treatment outcomes by being more responsive to individual needs.

What evidence suggests that ARTEMIS and contingency management could be effective for depression?

Research has shown that ARTEMIS aims to reduce depression and stimulant use. Early results suggest that this program can improve mood and behavior. ARTEMIS focuses on managing stress and enhancing emotional responses. Although detailed results from ARTEMIS studies are not yet widely available, its approach addresses significant emotional and behavioral challenges. This makes it a promising option for those dealing with depression and substance use, especially for individuals who are HIV positive. Participants in this trial will receive the ARTEMIS intervention immediately after randomization, while others will be in a waitlist control group and offered the intervention after the final follow-up. ^{1 2 4 6 7}

Who Is on the Research Team?

Adam W Carrico, PhD

Principal Investigator

Florida International University

Christina S Meade, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

Project neuroARTEMIS is for HIV-positive individuals on antiretroviral medications who also use stimulants. It aims to help with depression and substance use by understanding how chronic stress affects brain and immune function.

Inclusion Criteria

I have been diagnosed with HIV.

I am currently taking daily HIV medication.

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)

Exclusion Criteria

I do not have a current brain infection.

I am currently experiencing severe symptoms of bipolar I or a psychotic disorder.

I am prescribed immunotherapy or drugs that affect my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete psychosocial and behavioral measures, biospecimen collection, and an MRI brain scan

1 week

1 visit (in-person)

Treatment

ARTEMIS participants receive 5 sessions delivered individually over Zoom across 3 months, with contingency management for ART adherence

12 weeks

5 visits (virtual)

Follow-up

Participants are monitored for changes in neural activity and leukocyte signaling at 3- and 6-month follow-ups

6 months

2 visits (in-person)

Waitlist Control Intervention

WLC participants are offered the ARTEMIS intervention after a 6-month delay

12 weeks

5 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ARTEMIS
• Contingency management for Antiretroviral (ARV) adherence

Trial Overview

The trial tests ARTEMIS, a positive affect intervention designed to reduce stimulant use and improve mood in people with HIV/AIDS. Participants will also receive contingency management for sticking to their antiretroviral regimen.

How Is the Trial Designed?

Group I: Waitlist Control (WLC) Experimental Treatment 1 Intervention

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

Group II: ARTEMIS Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Florida International University

Collaborator

Trials

114

Recruited

19,400+

Published Research Related to This Trial

Enhanced evidence-based care (EEC) models, including Collaborative Care and Algorithm-guided Treatment, significantly improve treatment outcomes for depression compared to usual care, with a response rate increase of 30% and remission rate increase of 35% based on a meta-analysis of 29 studies involving 15,255 participants.

Despite the improved effectiveness of EEC, the rate of discontinuation from treatment was similar to that of usual care, indicating that EEC is a safe option for managing depression without increasing dropout rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of enhanced evidence-based care for depressive disorders: a meta-analysis of randomized controlled trials. Xiao, L., Qi, H., Zheng, W., et al.[2021]

Offering financial incentives significantly boosts engagement in mental health treatment, particularly for substance use disorders, with medium to large effect sizes for treatment attendance (Hedges' g = 0.49) and medication adherence (Hedges' g = 0.95).

The study highlights the need for further research on the effectiveness of financial incentives for a broader range of mental health disorders and emphasizes the importance of addressing ethical and systemic barriers to implementing these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do financial incentives increase mental health treatment engagement? A meta-analysis. Khazanov, GK., Morris, PE., Beed, A., et al.[2023]

A study involving stakeholder input identified increasing combination treatment rates (antidepressants plus psychotherapy) as a key goal for improving depression care in a managed behavioral healthcare organization.

The feasibility test of an incentive-based program showed that while it raised awareness among clinicians, challenges such as administrative barriers and limited clinical data may hinder widespread adoption of these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A collaborative approach to identifying effective incentives for mental health clinicians to improve depression care in a large managed behavioral healthcare organization. Meredith, LS., Branstrom, RB., Azocar, F., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38772584/

Protocol for process evaluation of ARTEMIS cluster ...

The aim of this paper is to describe the process evaluation protocol for ARTEMIS trial. The process evaluation will help to explain the intervention outcomes.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11110603/

Protocol for process evaluation of ARTEMIS cluster ...

The ARTEMIS cRCT will test an intervention to address depression, increased risk of self-harm/suicide or other significant emotional or ...

3.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06539-8

An intervention to reduce stigma and improve management of ...

The ARTEMIS study also attempts to understand and quantify the stigma towards mental illnesses among adolescents in urban slum communities and ...

4.

withpower.com

withpower.com/trial/artemis-contingency-management-for-depression-07c9b

ARTEMIS + Contingency Management for Depression

Through this intervention, the aim is to determine if this positive affect intervention can lead to reductions in stimulant use and depressed mood. Show more.

5.

georgeinstitute.org

georgeinstitute.org/our-research/research-projects/artemis-adolescents-resilience-and-treatment-needs-for-mental-health-in-indian-slums

Adolescents' Resilience and Treatment nEeds for Mental ...

Of those with depressive disorders, only 1 in 27 people receive effective treatment in low- and middle-income countries, such as India. Barriers to care ...

6.

mentalhealth.bmj.com

mentalhealth.bmj.com/content/28/1/e301381

A qualitative study exploring the feasibility and ...

Artemis-A is a digital tool using computerised adaptive testing (CAT) to quickly and reliably assess mental health risks in young people. What ...

7.

jmir.org

jmir.org/2024/1/e51376/

Digital Mental Health Interventions for Adolescents in Low- ...

We analyzed 20 papers focusing on DMHIs for various mental health conditions among adolescents, such as depression, well-being, anxiety, stigma, self-harm, and ...