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RECRUITING
NCT05966532

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

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

276

Start Date

2023-12-11

Completion Date

2026-08-31

Last Updated

2025-12-15

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Hot 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.

BEHAVIORAL

Cold 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.

OTHER

Structural 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.

OTHER

Magnetoencephalography 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.

BEHAVIORAL

four 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)

BEHAVIORAL

Four 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).

BEHAVIORAL

Clinical 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.

OTHER

ATHF

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