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)
University of Texas Southwestern Medical Center
276 participants
Dec 11, 2023
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
Inclusion Criteria6
- Male and female participants
- Age between 21-80 years old
- DSM-5 diagnosis of major depressive disorder (MDD) based on Mini Neuropsychiatric Interview
- Inventory of Depressive Symptomatology-Clinician Rated version (IDS-C) total score \> 14
- Able to read, write, and comprehend English
- Provide informed consent; willing to comply with study protocol
Exclusion Criteria11
- History of bipolar disorder, schizophrenia, or schizoaffective disorder
- Presence of psychotic features
- Lifetime central nervous system (CNS) disease (including head injury with loss of consciousness \> 5 minutes)
- History of neurodevelopmental disorder (e.g., Autism spectrum disorder)
- History of medical conditions that can affect neurocognitive function as well as be confounded with age (e.g., thyroid disease, endocrine illnesses)
- Women who are pregnant
- Current use of medications with known impacts on neurocognitive function (e.g., acetylcholinesterase inhibitors, amphetamine, methylphenidate, vortioxetine, sedatives)
- Alcohol/substance use disorder within past 3 months
- DSM-5 diagnosis of major cognitive impairment
- Current sensory or physical impairment that interferes with testing.
- Contraindication to MRI and MEG (only for depressed participants) (e.g., any electronic / metallic implants near or within the head or body, claustrophobia)
Interventions
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.
* 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.
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.
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.
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)
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).
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.
Psychotropic medication use/ treatment resistance level will be measured/documented with the Antidepressant Treatment History Form-Short-Form (ATHF-SF)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05966532