Testing the Neuroscience of Guided Learning in Depression

NCT ID: NCT03203954

Last Updated: 2022-07-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2021-12-31

Brief Summary

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

Major depression is a prevalent and impairing illness. To better understand the basic science and treatment of depression, the investigators study the behavioral and brain processes associated with learning in depression and how potential disruptions in learning may be repaired. Understanding different methods that change learning may lead to novel treatments that contribute to recovery in people with depression.

Detailed Description

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

Major depressive disorder ranks among the most significant causes of mortality and disability in the world. Recent data from the investigators and others highlight that impairments in reward and loss learning are central to depression, have distinct neural substrates, and improve with successful treatment. Together, these findings suggest an urgent need to delineate the relationships among neural and behavioral learning impairments and depression. Equally important, these insights suggest new targets for treatment such that manipulating the neural and behavioral substrates of learning may facilitate symptom change in depression.

To address these issues, the investigators use functional neuroimaging and a computational psychiatry framework to i) systematically characterize the neural and behavioral substrates that attend reward- and loss- learning in depression and ii) assess the degree to which learning in depression responds to two behavioral methods that target learning in different ways. The investigators test the broad hypotheses that i) that depression may be characterized by distinct neural and behavioral disruptions of learning, and ii) these disruptions and associated symptoms may be ameliorated through different methods of guiding learning. Recent advances in computational psychiatry provide a mechanism-based framework within which to understand the nature and trajectory of potential learning impairments in depression and suggest new ways that disrupted learning and associated symptoms may be improved in depression

Conditions

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

Major Depressive Disorder

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

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

No Training

Guided learning, standard learning: Repeat administration of standard behavioral learning task

Group Type ACTIVE_COMPARATOR

Standard Learning

Intervention Type BEHAVIORAL

Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.

Instructed Statistics

Guided learning, instructed statistics: Repeat administration of behavioral learning task with instructions about task statistics

Group Type EXPERIMENTAL

Guided Learning: Instructed statistics

Intervention Type BEHAVIORAL

Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.

Not Instructed Statistics

Guided learning, changing statistics: Repeat administration of behavioral learning task with changing task statistics

Group Type EXPERIMENTAL

Guided Learning: Changing statistics

Intervention Type BEHAVIORAL

Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.

Interventions

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

Standard Learning

Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.

Intervention Type BEHAVIORAL

Guided Learning: Instructed statistics

Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.

Intervention Type BEHAVIORAL

Guided Learning: Changing statistics

Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* males and females of all ethnicities
* meet diagnostic criteria for major depression or non-depressed control (assessed by study staff)
* ages 18-55
* fluent in English
* able to see computer display clearly
* able to provide informed consent
* able to follow verbal or written instructions
* for participants who are referred by a clinician, a letter from that clinician indicating that participation in the study does not constitute an elevated medical or behavioral risk to the participant will be requested.

Exclusion Criteria

* current pregnancy or menopause
* claustrophobia
* MRI contraindications
* psychotic or bipolar disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pearl Chiu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Virginia Tech Carilion Research Institute

Roanoke, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH106756

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MDDLEARNING

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Depression Management Project
NCT01150604 COMPLETED NA