Understanding how PTSD patients learn to avoid fear triggers

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

This study is testing how people with PTSD learn to avoid things that trigger their fear and how their brain reacts to this learning.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT04770584 on ClinicalTrials.gov

What this trial studies

This research investigates the neural mechanisms behind avoidance learning in individuals with post-traumatic stress disorder (PTSD) using a conditioning paradigm. The study aims to measure brain responses and emotional reactions as participants learn to avoid specific stimuli, while also examining how fear extinction learning and monetary costs influence these avoidance behaviors. Participants will include those diagnosed with PTSD, trauma-exposed healthy controls, and healthy controls without trauma history. The findings could enhance our understanding of avoidance in PTSD and inform treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18-70 with a current diagnosis of PTSD or those who have been exposed to trauma but do not have PTSD.

Not a fit: Patients with significant neurological disorders, severe suicidal ideation, or serious psychiatric diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved therapeutic approaches for PTSD by addressing avoidance behaviors that hinder recovery.

How similar studies have performed: Previous studies have explored similar mechanisms of avoidance and fear extinction, indicating potential for success in this approach.

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)

Where this trial is running

Houston, Texas

• UTHealth Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Mohammed Milad, PhD — The University of Texas Health Science Center at Houston (UTHealth Houston)
• Study coordinator: Mohammed Milad, PhD

Conditions Post Traumatic Stress Disorder