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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment ARTEMIS + Contingency Management for Depression?

Research shows that using financial incentives, like those in contingency management, can help people stick to their mental health treatments. Additionally, enhanced care models for depression, which include regular monitoring and adjustments, have been found to improve treatment outcomes. ^{1 2 3 4 5}

Research Team

Christina S Meade, PhD

Principal Investigator

Wake Forest University Health Sciences

Adam W Carrico, PhD

Principal Investigator

Florida International University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Do financial incentives increase mental health treatment engagement? A meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of enhanced evidence-based care for depressive disorders: a meta-analysis of randomized controlled trials. [2021]

3. United States 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Rationale, design, and methods of the systematic treatment enhancement program for bipolar disorder (STEP-BD). [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Using machine learning to forecast symptom changes among subclinical depression patients receiving stepped care or usual care. [2023]