Clinical trial NCT04770584: 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
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-02-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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 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.

Eligibility criteria: Inclusion Criteria:

1. 18 - 70 years of age
2. Female or Male
3. Inclusion Criteria: PTSD Subjects

   a. Diagnosis of current PTSD
4. Inclusion Criteria: Trauma-exposed healthy controls (TEHC)

   1. SCID diagnosis consistent with no current psychiatric disorders, and no current PTSD
   2. History of trauma exposure
5. Inclusion Criteria: Healthy controls (HC)

   1. SCID diagnosis consistent with no current psychiatric disorders ("Axis I" disorders).
   2. No history of trauma exposure
6. Willing and able to provide informed consent.

Exclusion Criteria for ALL subjects:

1. History of neurologic disease (e.g. tic disorder)
2. 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
3. History of seizure or significant head trauma
4. History of the serious/significant psychiatric diagnosis ("Axis I" disorders)
5. Use of neuroleptics within one year prior to study
6. 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)
7. Pregnancy (to be ruled out by urine ß-HCG)
8. Metallic implants or devices contraindicating magnetic resonance imaging
9. 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:
10. Current psychiatric diagnosis ("Axis I" diagnoses)

Primary outcomes:
measure: Skin Conductance Response (SCR)
timeFrame: Experimental Day 1, Experimental Day 2
measure: Functional MRI (fMRI) responses
timeFrame: Experimental Day 1, Experimental Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UTHealth Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Houston (UTHealth Houston)
name: Mohammed Milad, PhD
role: PRINCIPAL_INVESTIGATOR
References: