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Testing the Neuroscience of Guided Learning in Depression

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ClinicalTrials.gov Identifier: NCT03203954
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Pearl Chiu, Virginia Polytechnic Institute and State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Standard Learning Behavioral: Guided Learning: Instructed statistics Behavioral: Guided Learning: Changing statistics Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Neural Substrates of Reinforcement Learning and Its Training in Major Depression
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Task performance [ Time Frame: approximately 6 weeks (pre- post- learning task changes and interim time points) ]
    behavioral measures of learning task performance including accuracy, learning rate


Secondary Outcome Measures :
  1. Neuroimaging measures [ Time Frame: approximately 6 weeks (pre- post- learning task changes and interim time points) ]
    functional MRI during learning task performance

  2. Symptoms [ Time Frame: approximately 6 weeks (pre- post- learning task changes and interim time points) ]
    self-report questionnaires and clinician-obtained symptom measures



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203954


Contacts
Contact: Pearl Chiu, PhD 540-526-2032 chiup@vtc.vt.edu

Locations
United States, Virginia
Virginia Tech Carilion Research Institute Recruiting
Roanoke, Virginia, United States, 24016
Contact: Pearl Chiu, PhD    540-526-2032    chiup@vtc.vt.edu   
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
National Institute of Mental Health (NIMH)

Responsible Party: Pearl Chiu, Associate Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03203954     History of Changes
Other Study ID Numbers: MDDLEARNING
R01MH106756 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: following study completion, de-identified data will be made available to approved researchers and may be requested from the principal investigator

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders