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Fear and Avoidance in PTSD Patients
NCT04770584 · The University of Texas Health Science Center, Houston
In plain English
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Official title
Neural Correlates of Active Avoidance Learning and Their Interactions With Fear Extinction Mechanisms in PTSD Patients
About this study
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)
Study design
Enrollment target: 300 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-09-09
Estimated completion: 2027-01
Last updated: 2025-04-11
Interventions
Behavioral: Fear ConditioningOther: Avoidance conditioningOther: Pavlovian fear extinction learningOther: Willingness to pay to avoid shock
Primary outcomes
- • Skin Conductance Response (SCR) (Experimental Day 1, Experimental Day 2)
- • Functional MRI (fMRI) responses (Experimental Day 1, Experimental Day 2)
Sponsor
The University of Texas Health Science Center, Houston · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactMohammed Milad, PhD · contact · Mohammed.R.Milad@uth.tmc.edu · 713-486-2754
ContactIsabel Moallem, PhD · contact · B.Isabel.Moallem@uth.tmc.edu
InvestigatorMohammed Milad, PhD · principal_investigator, The University of Texas Health Science Center at Houston (UTHealth Houston)
All locations (1)
UTHealth HoustonRecruiting
Houston, Texas, United States