Testing the Neuroscience of Guided Learning in Depression

NCT03203954 | Completed

• 2 other identifiers: MDDLEARNINGR01MH106756
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Neuroimaging measures

  approximately 6 weeks (pre- post- learning task changes and interim time points)

• Symptoms

  approximately 6 weeks (pre- post- learning task changes and interim time points)

Study Arms (3)

No Training

ACTIVE COMPARATOR

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

Behavioral: Standard Learning

Instructed Statistics

EXPERIMENTAL

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

Behavioral: Guided Learning: Instructed statistics

Not Instructed Statistics

EXPERIMENTAL

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

Behavioral: Guided Learning: Changing statistics

Interventions

Standard Learning BEHAVIORAL

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

No Training

Guided Learning: Instructed statistics BEHAVIORAL

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

Instructed Statistics

Guided Learning: Changing statistics BEHAVIORAL

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

Not Instructed Statistics

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• current pregnancy or menopause
• claustrophobia
• MRI contraindications
• psychotic or bipolar disorder

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Virginia Tech Carilion Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 29, 2017
• Study Start: May 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)