Multimodal Differences in Effort-based Decision-Making in Depression (BBQS)

June 1, 2026 updated by: Georgia Institute of Technology

Multimodal Differences in Effort-based Decision-Making in Depression - - Brain Behavior Quantification and Synchronization

Major depressive disorder (MDD) is a serious condition that causes long-term symptoms such as feeling sad, losing interest in activities, and having thoughts of self-harm. Difficulty in making an effort is a key factor in functional impairment. Current methods to evaluate this difficulty use clinical assessments and computer-based tasks, but there is a gap between the measurements and real-life behavior. To address this, the study team proposes creating an instrumented behavioral test, HORMES, to objectively assess reduced motivation during everyday activities and measure physiological responses. The study will examine differences in brain activity, autonomic system function, and metabolic energy expenditure in patients with major depression during a decision-making task that involves physical effort.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Major depressive disorder (MDD) is a debilitating neuropsychiatric condition characterized by multiple chronic symptoms, including sad mood, anhedonia, psychomotor symptoms, and suicidal thoughts. MDD induces significant personal and societal suffering, becoming the largest contributor to the overall disease burden in developed countries. There is clearly an urgent need to advance our understanding of MDD and its constituent symptoms. Of these, the inability to expend effort have proven harder to treat than mood-related symptoms and are key predictors of functional impairment and disease burden. The biological mechanisms that contribute to this impairment are not fully understood. Addressing this gap in knowledge will be helpful in developing therapy, including novel brain stimulation therapies that offer the ability to target brain circuits precisely.

Current evaluation approaches to characterizing reduced motivation rely on clinical assessments of patient symptoms through interviews and observation. While these typically assess functions relevant to patient quality of life, these assessments may be confounded by biases. On the other hand, translational research focuses on characterizing symptoms using computer-based tasks that provide quantitative objective markers (e.g., reaction time in pressing a key on a keyboard) but may not reflect real-life situations. In addition, studies investigating brain mechanisms often use functional magnetic resonance imaging (fMRI), which requires patients to be stationary. Thus, there is a fundamental disconnect between measurements of behavior and the behavior itself under study.

To overcome these limitations, the study team envisions developing an instrumented behavioral assay, HORMES, that allows the objective assessment of reduced motivation during naturalistic behavior with concurrent measurements of the central and autonomic nervous systems as well as metabolic energy expenditure. This assay will utilize a CAREN system at Human Augmentation Core, a core facility available at Georgia Tech that is currently used for biomechanics research.

The proposed study will investigate differences in brain activity, autonomic system function, and metabolic energy expenditure in patients with major depression and matched controls during an effort-based decision-making task. The study team will collect multiple physiological measures - brain activity, cardiac activity, breathing activity, and energy expenditure in patients with major depression when they walk on a treadmill. Biomechanical information will be obtained using motion capture. The amount of effort they will need to expend will be varied by adjusting the treadmill's incline. These measures will be compared against those from a control group with age, gender, and BMI-matched healthy individuals.

The outcome of this study will inform what differences exist between healthy individuals and individuals with depression. The participants will be recruited from the Atlanta metro area and will all be allocated to the intervention. which is a behavioral task. The task requires participants to maximize rewards by choosing to pursue actions of different levels of physical effort (walking).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Matched control group

    • 18-65 years old
    • Able-bodied
    • Fluent in English
    • Able to give written and verbal informed consent to the proposed experiment
    • Able to comprehend the study procedure, potential risks, and benefits

  • Group with depression

    • Diagnosed with major depression
    • Quick Inventory of Depression Symptomology (QIDS) score > 5
    • 18-65 years old
    • Able-bodied
    • Fluent in English
    • Able to give written and verbal informed consent to the proposed experiment
    • Able to comprehend the study procedure, potential risks, and benefits

Exclusion Criteria:

  • Matched control group

    • Current diagnosed psychiatric disorder (e.g., anxiety, depression, bipolar disorder)
    • Current pregnancy
    • BMI > 35
    • Currently on antipsychotics

  • Group with depression

    • Diagnosed with psychotic symptoms
    • Diagnosed with other neurological or psychiatric disorders
    • Current pregnancy
    • BMI > 35
    • Currently on antipsychotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Effort-based decision-making
Participants perform a virtual-reality-based task in which they expend effort to receive virtual rewards.
Other: Effort-based Decision-Making Task
Virtual Reality-based multi-stage task in which individuals must explore distinct "rooms" in a virtual environment that vary in the amount of effort (walking) and reward (points) they receive.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time spent in high-effort "rooms"
Time Frame: 1 day
Participants will be measured on how much time they spend in "rooms" that require high effort in the form of walking on an inclined treadmill as a proportion of the total duration of the task. This measures the willingness of participants to engage in effortful behavior.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Icahn School of Medicine at Mount Sinai
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher J Rozell, Ph.D., Georgia Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H24306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared in the NIMH Data Archive (NDA) at the end of the project. De-identified data sets will be anonymized prior to posting on the public repository. Shared data will include behavioral task outcomes, physiological data, and participant demographics.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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