Fear and Avoidance in PTSD Patients

NCT04770584 | Recruiting DMC

• 2 other identifiers: HSC-MS-23-0495R01MH123736
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to study how the brain learns to avoid certain stimuli or situations using an experimental paradigm. The big goal is to measure brain responses and subject's feelings and expectations when they are learning to actively avoid experimental stimuli, and how fear extinction learning and monetary cost can change how and when subjects are to avoid.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Skin Conductance Response (SCR)

  Skin Conductance Response (SCR) assesses the stress/seat level, or level of anxiety in a particular moment, or in response to a specific cue. SCR will be reported in microsiemens.

  Experimental Day 1, Experimental Day 2

• Functional MRI (fMRI) responses

  fMRI data, including blood-oxygen-level-dependent (BOLD) responses, is used in neuroimaging studies assess neural correlate activations and observe the increase/decrease in activation of a particular brain area in response to a specific cue.

  Experimental Day 1, Experimental Day 2

Study Arms (1)

Emotional learning paradigm

EXPERIMENTAL

After the initial screening / baseline assessment visit, participants will undergo two Experimental Visits, which include participation in an emotional learning paradigm and an fMRI scan over the course of two consecutive days. Participants will be asked to look at pictures on a computer screen to measure physiological response physiological response (skin conductance response) and brain responses using a functional Magnetic Resonance Imaging (fMRI) machine. These two visits will be scheduled within a month from the baseline assessment visit.

Behavioral: Fear Conditioning; Other: Avoidance conditioning; Other: Pavlovian fear extinction learning; Other: Willingness to pay to avoid shock

Interventions

Fear Conditioning BEHAVIORAL

Participants will be administered increasing intensities of mild electric shock via electrodes connected to the foot. New Biopac stimulators that can deliver higher shock intensity, provided participants agreement will be used to assure adequate conditioning levels. Stimulation is measures in milliamps (mA), and each delivered stimulation will be 0.5 seconds long (500 milliseconds). To colored (blue, red, \& yellow) light stimuli (CS). The light stimulus is followed by a shock or no shock depending on color.

Emotional learning paradigm

Avoidance conditioning OTHER

Via button pressing. Only one stimulus-CS will enable control over experiencing the shock: the participant can press the button during the first 2 seconds of the light presentation to avoid the shock.

Emotional learning paradigm

Pavlovian fear extinction learning OTHER

After avoidance conditioning, the CS+ associated with avoidance responding appears with no button to press and no shock is administered.

Emotional learning paradigm

Willingness to pay to avoid shock OTHER

On the next day, participants receive a monetary stipend to use to pay to guarantee that they are not to receive any shocks if they press a button from the CS+. This and all previously described experimental phases noted above will occur inside of the fMRI scanner.

Emotional learning paradigm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Female or Male
• a. Diagnosis of current PTSD
• SCID diagnosis consistent with no current psychiatric disorders, and no current PTSD
• History of trauma exposure
• SCID diagnosis consistent with no current psychiatric disorders ("Axis I" disorders).
• No history of trauma exposure
• Willing and able to provide informed consent.

You may not qualify if:

• History of neurologic disease (e.g. tic disorder)
• Current significant suicidal ideation, plan or intent or suicidal behavior in past 6 months based on CSSRS or Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily
• History of seizure or significant head trauma
• History of the serious/significant psychiatric diagnosis ("Axis I" disorders)
• Use of neuroleptics within one year prior to study
• Current substance use (assessed by urine toxicology; positive urine toxicology screen for any substance, with the exception of THC). Per PI judgement and approval: if urine toxicology is positive for a substance, participant may be eligible to proceed with study provided their urine toxicology (or saliva test for THC) is negative at experimental visit(s)
• Pregnancy (to be ruled out by urine ß-HCG)
• Metallic implants or devices contraindicating magnetic resonance imaging
• High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process
• Current psychiatric diagnosis ("Axis I" diagnoses)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UTHealth Houston

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Mohammed Milad, PhD

  The University of Texas Health Science Center at Houston (UTHealth Houston)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Milad, PhD

CONTACT

713-486-2754; Mohammed.R.Milad@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: September 9, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access and give upon reasonable request. Requests should be directed to Mohammed.R.Milad@uth.tmc.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)