Testing the Neuroscience of Guided Learning in Depression

Neural Substrates of Reinforcement Learning and Its Training in Major Depression

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Standard Learning; Behavioral: Guided Learning: Instructed statistics; Behavioral: Guided Learning: Changing statistics

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Virginia Tech Carilion Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No Training; Guided learning, standard learning: Repeat administration of standard behavioral learning task	Behavioral: Standard Learning; Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
Experimental: Instructed Statistics; Guided learning, instructed statistics: Repeat administration of behavioral learning task with instructions about task statistics	Behavioral: Guided Learning: Instructed statistics; Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
Experimental: Not Instructed Statistics; Guided learning, changing statistics: Repeat administration of behavioral learning task with changing task statistics	Behavioral: Guided Learning: Changing statistics; Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Task performance	behavioral measures of learning task performance including accuracy, learning rate	approximately 6 weeks (pre- post- learning task changes and interim time points)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroimaging measures	functional MRI during learning task performance	approximately 6 weeks (pre- post- learning task changes and interim time points)
Symptoms	self-report questionnaires and clinician-obtained symptom measures	approximately 6 weeks (pre- post- learning task changes and interim time points)

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: MDDLEARNING; R01MH106756 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: following study completion, de-identified data will be made available to approved researchers and may be requested from the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No