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

NCT05966532 | Active Not Recruiting

• 2 other identifiers: STU-2021-1131R21MH130870
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Major Depressive Disorder (MDD); Healthy Adult Volunteer

Keywords

Emotional Cognition

Outcome Measures

Primary Outcomes (7)

• Emotion Processing Domain: Emotional Intensity Morphing Task

  Assesses the point of intensity for fascial emotion recognition. Faces are presented with slowly morphing emotional expressions (e.g., happy, sad, angry) that increases (point of detection) or decrease (emotion no longer perceived). Intensity threshold for each emotion and each condition (i.e., increases and decrease).

  baseline visit, total time= 5 minutes

• Emotion Processing Domain: Emotional Recognition Task-Eyes

  Assesses accuracy and affective bias of emotional recognition. Participants identify emotion(e.g., happy, sad) based on 250ms presentation of eyes only. Hit rate (i.e., correct identification of each emotion).

  baseline visit, total time= 12 minutes

• Emotion Processing Domain: Face Affective Go No-Go

  Assesses affective bias associated with emotional faces. Participant must identify the target facial emotion (e.g., happy, sad), while ignoring other emotions. Discrimination accuracy (d-prime score for each emotion).

  baseline visit, total time= 6 minutes

• Reward Processing and Learning: Adapted Cambridge Gambling Task

  Assesses value-based choice. Participants bet on expected outcomes when presented with a colored (orange, purple) roulette wheel with the proportions of each color indicating 1 of 5 levels of certain/uncertain outcomes in the context of win or loss conditions. Risk Adjustment scores based on level of probability of win or loss.

  baseline visit, total time= 10 minutes

• Reward Processing and Learning: Reinforcement Learning Task

  Assesses reward and punishment learning. Participants are shown colored circles and choose the one they believe is more likely to win money. There are two conditions (no lose and no win). Learning rate (alpha) based on how fast participant learns new information (both win and loss). Risk Adjustment scores based on level of probability of win or loss.

  baseline visit, total time= 10 minutes

• Impulsivity: Discounting Task

  Assesses rate of discounting across 5 levels of delay and 5 of probability. Participants decide between a standard fixed amount vs an immediately available alternative. Indifference points for each length of delay/degree of uncertainly, noted by area under the curve.

  baseline visit, total time= 7 minutes

• Social Cognition: Moral Emotions Task

  Assesses moral judgment/emotional reactions to social situations. Cartoons depict characters intentionally or unintentionally harming one another. Participants rate feelings (e.g., guilt, shame) as either the victim or antagonizer in the scenario. Average ratings of guilt and shame in each scenario (victim or antagonizer).

  baseline visit, total time= 13 minutes

Secondary Outcomes (8)

• Montreal Cognitive Assessment (MoCA): Cold Cognitive Function Testing.

  Day 1/baseline

• Everyday Cognition (ECog): Cold Cognitive Function Testing

  Day 1

• Test of Premorbid Function (TOPF): Cold Cognitive Function Testing

  Day 1

• California Verbal Learning Test-3 (CVLT-3): Cold Cognitive Function Testing

  Day 1

• Delis-Kaplan Executive Function System (DKEF)-Color-Word Interference: Cold Cognitive Function Testing

  Day 1

Study Arms (2)

Major Depressive Disorder (MDD) Participants:

1. Male and female subjects 2. Age between 21-80 years old 3. Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of major depressive disorder (MDD) based on Mini Neuropsychiatric Interview 4. Inventory of Depressive Symptomatology; Clinician Rated version (IDS-C) total score \> 14 5. Able to read, write, and comprehend English 6. Provide informed consent; willing to comply with study protocol. Note: For individuals with MDD diagnosis: As part of the screening procedures, the Mini International Neuropsychiatric Interview (MINI-7.0 for DSM-5) will be conducted to determine eligibility. This is related to Inclusion Criteria #3.

Behavioral: Hot Cognitive Task; Behavioral: Cold cognitive tasks; Other: Structural magnetic resonance imaging (sMRI); Other: Magnetoencephalography imaging (MEG); Behavioral: four self-report forms per the requirement of the NIH Common Data Elements project; Behavioral: Four self-report measures to assess interpersonal functioning; Behavioral: Clinical assessments; Other: ATHF

Healthy Volunteer Participants:

1. Male and female subjects 2. Age between 21-80 years old 3. Able to read, write, and comprehend English 4. Provide informed consent; willing to comply with study protocol

Behavioral: Hot Cognitive Task; Behavioral: Cold cognitive tasks; Behavioral: four self-report forms per the requirement of the NIH Common Data Elements project; Behavioral: Four self-report measures to assess interpersonal functioning; Behavioral: Clinical assessments

Interventions

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

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)

Healthy Volunteer Participants:; Major Depressive Disorder (MDD) Participants:

Hot Cognitive Task BEHAVIORAL

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.

Healthy Volunteer Participants:; Major Depressive Disorder (MDD) Participants:

Cold cognitive tasks BEHAVIORAL

* 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.

Healthy Volunteer Participants:; Major Depressive Disorder (MDD) Participants:

Clinical assessments BEHAVIORAL

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.

Healthy Volunteer Participants:; Major Depressive Disorder (MDD) Participants:

Structural magnetic resonance imaging (sMRI) OTHER

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.

Major Depressive Disorder (MDD) Participants:

Magnetoencephalography imaging (MEG) OTHER

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.

Major Depressive Disorder (MDD) Participants:

Four self-report measures to assess interpersonal functioning BEHAVIORAL

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).

Healthy Volunteer Participants:; Major Depressive Disorder (MDD) Participants:

ATHF OTHER

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

Major Depressive Disorder (MDD) Participants:

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Investigators will study 120 participants aged 21-80 years old with major depressive disorder (MDD). Participants with MDD will undergo clinical and neurocognitive assessment, and MEG/MRI procedures at one time point. Investigators team 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, research teams 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• The University of Texas at Arlington: collaborator
• National Institute of Mental Health (NIMH): collaborator
• JERRY M LEWIS MENTAL HEALTH RSRCH FDTN: collaborator

Study Sites (2)

University of Texas Arlington

Arlington, Texas, 76010, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9127, United States

Location

Related Links

• EMOTICOM: A Neuropsychological Test Battery to Evaluate Emotion, Motivation, Impulsivity, and Social Cognition

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-12

Locations

US (2)