Effort-based Decision-Making Task for Depression

(BBQS Trial)

Overseen By Sankaraleengam Alagapan, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia Institute of Technology

Must not be taking: Antipsychotics

Disqualifiers: Psychotic symptoms, Neurological disorders, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure motivation in individuals with major depressive disorder (MDD). It employs a virtual-reality task called the Effort-based Decision-Making Task, where participants exert physical effort to earn virtual rewards. Researchers aim to observe changes in brain activity and body responses when individuals with depression make effort-based decisions. This trial suits those diagnosed with major depression who struggle with motivation in daily activities. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance the understanding and treatment of depression.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are currently on antipsychotics.

What prior data suggests that this instrumented behavioral test is safe for assessing motivation in depression?

Research shows that tasks involving effort-based decision-making are under study to understand and address motivation issues in depression. The specific task under investigation, called HORMES, has not undergone safety testing like medications, but using decision-making tasks in research is well-established. These tasks typically involve simple activities where participants decide how much effort to invest for certain rewards.

Studies have shown that these tasks can safely explore how motivation and decision-making function in people with depression. They focus on how choices are made, rather than on physical treatments that might cause harm. Participants generally handle them well. Reports indicate no negative effects from these tasks, as they mainly involve virtual activities that mimic real-life situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Effort-based Decision-Making Task for depression because it offers a novel, non-pharmacological approach to treatment. Unlike traditional antidepressants that target chemical imbalances in the brain, this method uses a virtual-reality task to engage patients in active decision-making and effort expenditure, potentially rewiring cognitive pathways related to motivation and reward. This unique approach could provide a new avenue for those who do not respond well to medication, offering a side-effect-free alternative and enhancing the understanding of how effort and reward systems can be leveraged in treating depression.

What evidence suggests that this effort-based decision-making task is effective for assessing motivation in major depressive disorder?

Research shows that people with major depressive disorder (MDD) often feel less motivated to work for rewards. Studies have found that while MDD patients complete tasks requiring effort at similar rates to those without MDD, they feel less motivated to do so. This reduced motivation, known as motivational anhedonia, means patients find less enjoyment in activities that require effort. Although they may finish tasks at the same rate, MDD patients are less eager to start tasks that need effort. This trial involves participants performing an effort-based decision-making task designed to better measure these motivation levels, potentially improving understanding and treatment of depression-related motivation issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Christopher J Rozell, Ph.D.

Principal Investigator

Georgia Institute of Technology

Are You a Good Fit for This Trial?

This trial is for individuals with major depressive disorder (MDD), particularly those who experience anhedonia or a lack of pleasure in daily activities. Participants should have difficulty making efforts, which affects their day-to-day functioning.

Inclusion Criteria

I am 18-65, diagnosed with major depression, and understand the study's risks and benefits.

Exclusion Criteria

I have depression but no psychosis, other mental disorders, am not pregnant, my BMI is 35 or less, and I'm not on antipsychotics.

I do not have a psychiatric disorder, am not pregnant, my BMI is 35 or less, and I am not taking antipsychotics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Effort-based decision-making task

Participants perform a virtual-reality-based task in which they expend effort to receive virtual rewards. The task involves walking on a treadmill with varying inclines to measure physiological responses and effort-based decision-making.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the task, with a focus on physiological and behavioral outcomes.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Effort-based Decision-Making Task

Trial Overview The study is testing a new behavioral test called HORMES designed to objectively assess motivation and effort during everyday tasks. It will measure brain activity, autonomic system function, and energy use while participants complete a decision-making task that requires physical effort.

How Is the Trial Designed?

Group I: Effort-based decision-making Experimental Treatment 1 Intervention

Participants perform a virtual-reality-based task in which they expend effort to receive virtual rewards.

Who Is Running the Clinical Trial?

Georgia Institute of Technology

Lead Sponsor

Trials

53

Recruited

5,600+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3730492/

Effort-Based Decision-Making in Major Depressive Disorder There was no difference in the percentage of trials successfully completed by MDD patients (Mean = 99.4%, SD = 0.19%) or controls (Mean = 99.5%, SD = 0.15%) (t ...

2. biorxiv.org biorxiv.org/content/10.1101/2024.06.17.599286v1.full-text

A computational approach to understanding effort-based ... Traditional model-agnostic analyses showed that both depressed groups showed lower willingness to exert effort. In contrast with previous ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451902225000631?dgcid=rss_sd_all

Computational Phenotyping of Effort-Based Decision ... Effort-based decision-making in major depressive disorder ... Reduced hedonic capacity in major depressive disorder: evidence from a probabilistic reward task.

4. cambridge.org cambridge.org/core/journals/psychological-medicine/article/cognitive-effortbased-decisionmaking-in-major-depressive-disorder/5A9BB668B20F5929B438E024E4C6A272

Cognitive effort-based decision-making in major ... We developed a new task – the Cognitive Effort Motivation Task – to assess one's willingness to exert cognitive effort for rewards.

5. researchgate.net researchgate.net/publication/229008633_Effort-Based_Decision-Making_in_Major_Depressive_Disorder_A_Translational_Model_of_Motivational_Anhedonia

Effort-Based Decision-Making in Major Depressive Disorder We found that MDD patients were less willing to expend effort for rewards than controls. Additionally, we observed that patients were less able ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7349528/

Effort-Based Decision-Making and Gross Motor Performance The purpose of this study was to investigate the relationship between effort-based decision making and gross motor performance.

7. biorxiv.org biorxiv.org/content/10.1101/2025.07.24.666522v1.full-text

Effort choices are sensitive to prior learning Overall participants' effort choices were sensitive to effort level (F (1, 251) = 353.6, p < 0.001), outcome magnitude (F (1, 251) = 71.82, p < ...

8. nature.com nature.com/articles/s41598-020-60230-z

Multiple Facets of Value-Based Decision Making in Major ... These results confirm hints from single task studies that depression has the strongest effects on reinforcement learning and expectations about the future.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796723000554

Depression and approach-avoidance decisions to ... Depression is linked to altered motivational systems and effort-based decisions. •. Whether such deficits extend to social decisions remains unclear.

10. researchgate.net researchgate.net/publication/396331910_A_computational_approach_to_understanding_effort-based_decision-making_in_depression

A computational approach to understanding effort-based ... Conclusions This work provides insight into the computational mechanisms underlying motivational dysfunction in depression. Lower willingness to ...