Testing the Neuroscience of Guided Learning in Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Learning
Guided Learning: Instructed statistics
Guided Learning: Changing statistics
Sponsored by
About this trial
This is an interventional other trial for Major Depressive Disorder
Eligibility 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
Sites / Locations
- Virginia Tech Carilion Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
No Training
Instructed Statistics
Not Instructed Statistics
Arm Description
Guided learning, standard learning: Repeat administration of standard behavioral learning task
Guided learning, instructed statistics: Repeat administration of behavioral learning task with instructions about task statistics
Guided learning, changing statistics: Repeat administration of behavioral learning task with changing task statistics
Outcomes
Primary Outcome Measures
Task performance
behavioral measures of learning task performance including accuracy, learning rate
Secondary Outcome Measures
Neuroimaging measures
functional MRI during learning task performance
Symptoms
self-report questionnaires and clinician-obtained symptom measures
Full Information
NCT ID
NCT03203954
First Posted
June 23, 2017
Last Updated
July 7, 2022
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03203954
Brief Title
Testing the Neuroscience of Guided Learning in Depression
Official Title
Neural Substrates of Reinforcement Learning and Its Training in Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No Training
Arm Type
Active Comparator
Arm Description
Guided learning, standard learning: Repeat administration of standard behavioral learning task
Arm Title
Instructed Statistics
Arm Type
Experimental
Arm Description
Guided learning, instructed statistics: Repeat administration of behavioral learning task with instructions about task statistics
Arm Title
Not Instructed Statistics
Arm Type
Experimental
Arm Description
Guided learning, changing statistics: Repeat administration of behavioral learning task with changing task statistics
Intervention Type
Behavioral
Intervention Name(s)
Standard Learning
Intervention Description
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
Intervention Type
Behavioral
Intervention Name(s)
Guided Learning: Instructed statistics
Intervention Description
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
Intervention Type
Behavioral
Intervention Name(s)
Guided Learning: Changing statistics
Intervention Description
Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
Primary Outcome Measure Information:
Title
Task performance
Description
behavioral measures of learning task performance including accuracy, learning rate
Time Frame
approximately 6 weeks (pre- post- learning task changes and interim time points)
Secondary Outcome Measure Information:
Title
Neuroimaging measures
Description
functional MRI during learning task performance
Time Frame
approximately 6 weeks (pre- post- learning task changes and interim time points)
Title
Symptoms
Description
self-report questionnaires and clinician-obtained symptom measures
Time Frame
approximately 6 weeks (pre- post- learning task changes and interim time points)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Virginia Tech Carilion Research Institute
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
following study completion, de-identified data will be made available to approved researchers and may be requested from the principal investigator
Learn more about this trial
Testing the Neuroscience of Guided Learning in Depression
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