RecruitingNCT05966532

Emotional Cognition: Establishing Constructs and Neural-Behavioral Mechanisms in Older Adults With Depression

Emotional Cognition: Establishing Constructs and Neural-Behavioral Mechanisms in Older Adults With Depression (ENSURE; R21 MH130870)


Sponsor

University of Texas Southwestern Medical Center

Enrollment

276 participants

Start Date

Dec 11, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This is a cross-sectional pilot study designed to establish hot and cold cognitive functions and underlying neurocircuitry in older adults with MDD. The investigators will study 120 participants aged 21-80 years old with MDD. All participants will undergo clinical and neurocognitive assessment, and Magnetoencephalography (MEG)/Magnetic resonance imaging (MRI) procedures at one time point. The investigators will also enroll 120 demographically matched comparable, never-depressed healthy participants (controls) to establish cognitive benchmarks. Healthy controls will complete clinical and neurocognitive measures at one time point. To attain a balanced sample of adults across the lifespan, the investigators will enroll participants such that each age epoch (e.g., 21-30, 31-40, etc.) has a total of ten subjects (n=10) in both the healthy control cohort and depressed cohort.


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how people with major depression process and respond to emotional information — such as facial expressions or emotional words — compared to people without depression. The goal is to better understand the brain mechanisms behind emotional thinking in depression, which could improve future treatments. **You may be eligible if...** - You are between 21 and 80 years old - You have a DSM-5 diagnosis of major depressive disorder (MDD) - Your depression symptoms are at least moderate in severity (IDS-C score above 14) - You can read, write, and comprehend English - You are willing to comply with study procedures including brain scans **You may NOT be eligible if...** - You have a history of bipolar disorder, schizophrenia, or schizoaffective disorder - You have active psychosis or severe suicidal ideation requiring immediate intervention - You have a brain injury or neurological condition affecting cognition - You have a pacemaker or metal implants that make brain MRI unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHot Cognitive Task

1. Emotion processing: * Participants will be shown a series of faces that appear quickly and be asked to identify what emotion is shown. * Participants will be shown a face of an emotion and indicate if participant can see the emotion changing. * Participant will be shown a series of emotions and asked to respond to only a specific emotion. 2. Motivation reward and processing: * Participant will play with a simulated roulette and make a bet to evaluate their decision-making behavior. * Participant will be shown colored circles and choose the one more likely to win money. 3. Impulsivity: • Participant will be shown a series of stimuli where they will be asked to respond to the correct stimulus. 4. Social cognition: * Participant will be shown a series of moral situations in which a character is accidentally or intentionally harmed and be asked to rate the degree of guilt from the perspective of the victim or perpetrator.

BEHAVIORALCold cognitive tasks

* Montreal Cognitive Assessment (MoCA) - This will ask participants questions related to their cognition such as visuospatial skills, naming, memory, attention, language, and recall. * Measurement of Everyday Cognition (ECog) - This scale will ask participants about their everyday memory, language, visuospatial ability, organization, and divided attention. * Test of Premorbid Function (TOPF) - This test will evaluate memory performance and abilities of stud participants before onset pre-morbid status. * California Verbal Learning Test -3rd Edition (CVLT-3) -This test will measure verbal learning and memory of study participants. * Three tests from the Delis-Kaplan Executive Function System (D-KEFS; Verbal Fluency, Color-Word Interference, and Tower Tests). -These measures assess word finding and problem-solving ability.

OTHERStructural magnetic resonance imaging (sMRI)

This is a non-invasive procedure to assess the structure and function of participant's brain. Structural neuroanatomical data will be acquired using structural magnetic resonance. Imaging (sMRI) with the University of Texas Southwestern (UTSW) 3T (three Tesla field) MRI scanner. Prior to participation, the investigator's team will screen participant's to ensure eligibility to participate in the sMRI scan.

OTHERMagnetoencephalography imaging (MEG)

This is a non-invasive procedure to measure participant's brain activity. Participants will be sitting inside the machine in a chamber, with more space than a traditional MRI machine. A hat will be placed on top of participant's head which records their brain activity. Resting-state and task-based MEG recordings will occur in a three-layer magnetically shielded room (MSR) following our UTSW Advanced Neuroscience Imaging Research (ANSIR) established procedures. Before the scan, five coils will be secured to participant's head and a three-dimensional (3D) digitizer will be used to map the location of the coils, fiducials, and scalp surface. During recording, an electric current with a unique frequency label (i.e., 320 Hz) will be fed to each coil, which will permit real time head location tracking and subsequent offline head motion correction.

BEHAVIORALfour self-report forms per the requirement of the NIH Common Data Elements project

1\) DSM-5 Level 1 Cross Cutting Symptom Measure - Adult Report; a measure of multiple psychiatric symptoms, 2) Generalized Anxiety Disorder-7 (GAD-7; a measure of anxiety symptom severity), 3) Patient Health Questionniare-9 (PHQ-9; a measure of depression symptom severity), and 4) World Health Organization Disability Assessment Scale-2.0 (WHODAS-2.0; a measure of overall general functional status)

BEHAVIORALFour self-report measures to assess interpersonal functioning

1\) Social Adjustment Scale - Self-report Short Form (SAS-SR: Short), 2) Inventory of Interpersonal Problems (IIP-64), 3) Social Network Index (SNI), 4) Interpersonal Support Evaluation List - 12 Items (ISEL-12).

BEHAVIORALClinical assessments

A Demographic and a Medical History Form will be completed. The Mini International Neuropsychiatric Interview (MINI-7.0 for DSM-5) is a structured psychiatric interview that will confirm presence of MDD and any exclusionary neuropsychiatric disorders. To measure depression symptoms/severity, primarily we will use the Clinician Rated Inventory of Depressive Symptomatology (IDS-C), Menstrual history and pregnancy tests for female participants.

OTHERATHF

Psychotropic medication use/ treatment resistance level will be measured/documented with the Antidepressant Treatment History Form-Short-Form (ATHF-SF)


Locations(2)

University of Texas Arlington

Arlington, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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