Back to results

Fear and Avoidance in PTSD Patients

Primary Purpose

Post Traumatic Stress Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fear Conditioning

Avoidance conditioning

Pavlovian fear extinction learning

Willingness to pay to avoid shock

About this trial

This is an interventional basic science trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18 - 70 years of age
Female or Male
Inclusion Criteria: PTSD Subjects
a. Diagnosis of current PTSD (as determined by CAPS, and primary diagnosis of PTSD as determined by SCID assessment of comorbidity)
Inclusion Criteria: Trauma-exposed healthy controls (TEHC)
1. SCID diagnosis consistent with no current or past history of Axis I psychiatric disorders, and no current or past history of PTSD (as determined by the CAPS).
2. History of trauma exposure.
Willing and able to provide informed consent.

Exclusion Criteria for ALL subjects:

History of neurologic disease (e.g. tic disorder)
Current 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 (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion)
History of the following Axis I psychiatric diagnosis: psychotic disorder, bipolar disorder, current eating disorder, or current or early remission substance abuse disorder.
Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics).
Current substance use (assessed by urine toxicology; positive urine toxicology screen for any substance, with the exception of THC).
Pregnancy (to be ruled out by urine ß-HCG).
Metallic implants or devices contraindicating magnetic resonance imaging.
Additional exclusion criteria for Trauma-exposed healthy controls (TEHC) group:
History of Axis I psychiatric diagnosis (current/past); (e.g., substance use disorder, eating disorder, mood disorders, anxiety disorders, OCD, PTSD).

Sites / Locations

NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

PTSD group

Trauma-Exposed Healthy Controls (TEHC)

Arm Description

After the initial screening / baseline assessment visit, Post Traumatic Stress Disorder participants will undergo two Experimental Visits, which included 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.

After the initial screening / baseline assessment visit, trauma-exposed healthy participants will undergo two Experimental Visits, which included 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.

Outcomes

Primary Outcome Measures

Comparison of Skin Conductance Response (SCR) of PTSD participants and Trauma-Exposed Healthy Controls

Skin Conductance Response will be collected from subjects during the entire course of the experiment, inside or outside of the fMRI scanner, to measure stress/sweat level. SCR is used by many psychological experiments to measure the participants stress/sweat, or level of anxiety in a particular moment, or in response to a specific cue.

Comparison of fMRI data of PTSD participants and Trauma-Exposed Healthy Controls

Participants will undergo a 3T MRI scan during the both experimental. All standard sequences and RF coils which we intend to use at the Center for Brain Imaging are FDA certified.fMRI data will be collected from subjects during the entire course of the 2-day experiment inside the fMRI scanner. 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.

Secondary Outcome Measures

Change in Anxiety

State-Trait Anxiety Inventory STAI (State) The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.

Change in Emotional Stress tolerance

Distress Tolerance Scale (DTS) is a 15 item self-report measure of emotional distress tolerance. Individuals select on a 1-5 likert scale. (Strongly Disagree, Mildly Disagree, Feel Neutral, Mildly Agree, Strongly Agree) about each of the 16 statements about distress.

Change in shock expectancy

Shock expectancy questionnaire is a self reported questionnaire that measures what they expect to see certain colors and whether they expected to feel shocks in the study.

Ratings of Pleasantness in Conditioned Stimuli and Unconditioned Stimulus

Pleasantness Rating of relief scale measures participants sense of the relief they felt when no shock was given, on a scale from 1 to 5 (1=neutral, 5=extremely pleasant)

Ratings of Unpleasantness in Conditioned Stimuli and Unconditioned Stimulus

Rating of Conditioned Stimuli(CS) and Unconditioned Stimulus (US) Unpleasantness measures participants sense of the unpleasantness they felt when the CS was given, on a scale from 1 to 5 (1=neutral, 5=extremely pleasant)

Full Information

NCT ID

NCT04770584

First Posted

February 22, 2021

Last Updated

January 3, 2023

Sponsor

NYU Langone Health

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT04770584

Brief Title

Fear and Avoidance in PTSD Patients

Official Title

Neural Correlates of Active Avoidance Learning and Their Interactions With Fear Extinction Mechanisms in PTSD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to study how the brain learn 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.

Detailed Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Traumatic Stress Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PTSD group

Arm Type

Other

Arm Description

Arm Title

Trauma-Exposed Healthy Controls (TEHC)

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Fear Conditioning

Intervention Description

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 (blue & red - shock; yellow - no shock).

Intervention Type

Other

Intervention Name(s)

Avoidance conditioning

Intervention Description

Via button pressing. Only one stimulus-CS (i.e. blue colored light) 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. CS stays on for 6 seconds after the button is pressed. If the button is pressed, no shock will be administered. After 6 seconds, the light ends and the relief epoch ('good feeling') begins. Pressing the button to the other CS (i.e. red colored light) will not prevent the shock from occurring- the participant will still receive the mild shocked at CS offset (after 6 seconds). The third CS (i.e. yellow light) will serve as a control CS, so while the button is available, pressing it or not is of no consequence.

Intervention Type

Other

Intervention Name(s)

Pavlovian fear extinction learning

Intervention Description

After avoidance conditioning, the CS+ associated with avoidance responding (i.e. blue light) appears with no button to press and no shock is administered.

Intervention Type

Other

Intervention Name(s)

Willingness to pay to avoid shock

Intervention Description

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+. No shocks will be delivered on day 2, regardless of money paid. This and all previously described experimental phases noted above will occur inside of the fMRI scanner.

Primary Outcome Measure Information:

Title

Comparison of Skin Conductance Response (SCR) of PTSD participants and Trauma-Exposed Healthy Controls

Description

Time Frame