Biomarker Establishment for Superior Treatment of PTSD

Completed

• Conditions: PTSD
• Interventions: Other: Psychotherapy

• Registration Number: NCT03343028
• Lead Sponsor: Stanford University

Brief Summary

The purpose of Biomarker Establishment for Superior Treatment of PTSD is to accelerate research on the discovery of biological, neurological and neuroimaging markers for Post- Traumatic Stress Disorder (PTSD). The investigators hope to validate and extend the network efficiency and verbal memory biomarker for PTSD. The investigators hope to learn whether there are pretreatment biological factors that can predict response to therapy. They want to do this by understanding the brain network function, relating EEG to functional magnetic resonance imaging, and application of network analysis tool.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

• Diagnosis of PTSD by VA clinicians and acceptance into PE or CPT treatment as part of the PCT
• Veterans of any era

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Exclusion Criteria

• MRI safety contraindications
• Active, uncontrolled medical illness
• Acute suicidality
• Current substance dependence
• Current use of thyroid medication or active hyper/hypothyroidism
• Neurological disorder affecting the CNS Seg stroke, epilepsy, tumorW or penetrating head injury
• Use of PRN within 48 hours of the MRI/EEG

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psychotherapy	Psychotherapy	The investigators will assess and acquire data on these Veterans across the course of the project prior to and after receiving Prolonged Exposure (PE) or Cognitive Processing Theory (CPT) treatment at VA Palo Alto (VAPAHCS) and the Albuquerque VA. They will acquire fMRI, behavioral, EEG, TMS/EEG, and saliva at baseline on these Veterans and again 3 months after treatment to assess prediction and durability of the clinical and brain/behavioral metrics. All study assessments will take place at Stanford University/VAPAHCS. Subjects will be recruited through VAPAHCS and Albuquerque VA. Subjects will complete a clinical assessment including: neuroimaging, self-report questionnaires completed via computer or paper-and-pencil, cognitive testing, saliva, and TMS and EEG assessments.

Primary Outcome Measures

Name	Time	Method
Understanding the brain network function-neuroimaging and behavioral with Clinician-Administered PTSD Scale for DSM-5	Approximately 3 months	We will be using CAPS 5

Trial Locations

Locations (2)

VA Palo Alto Health Care System (VAPAHCS); 🇺🇸 Palo Alto, California, United States

New Mexico VA Health Care System; 🇺🇸 Albuquerque, New Mexico, United States