Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH123736 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
This study aims to study the neural correlates of avoidance learning using a recently validated conditioning and active avoidance paradigm (CAAP). The overarching objective is to measure the neural correlates of active avoidance, and how fear extinction learning and monetary cost modulate these avoidance responses. Participants will include healthy controls (HC), trauma-exposed healthy controls (TEHC), and participants with post-traumatic stress disorder (PTSD). Avoidance is common and often hinders the progression and success of extinction-based exposure therapy in PTSD. The data to be gathered in this study will enable us to probe neural mechanisms of avoidance, extinction, and decision-making to avoid or not, in addition to understanding the impact of cost on avoidance decision-making. These data will provide a more integrated platform for the understanding of the mechanisms of avoidance in both trauma-exposed healthy controls and PTSD psychopathology, which has important implications for treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
18 - 70 years of age
Female or Male
Inclusion Criteria: PTSD Subjects
a. Diagnosis of current PTSD
Inclusion Criteria: Trauma-exposed healthy controls (TEHC)
Inclusion Criteria: Healthy controls (HC)
Willing and able to provide informed consent.
Exclusion Criteria for ALL subjects:
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
Additional exclusion criteria for Trauma-exposed healthy controls (TEHC) group and Healthy controls (HC) group:
Current psychiatric diagnosis ("Axis I" diagnoses)
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Milad, PhD | Contact | 713-486-2754 | Mohammed.R.Milad@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed Milad, PhD | The University of Texas Health Science Center at Houston (UTHealth Houston) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHealth Houston | Recruiting | Houston | Texas | 77054 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
|
| 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. |
|