Biomarker Establishment for Superior Treatment of PTSD

NCT ID: NCT03343028

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 292 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

PTSD

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Psychotherapy

Intervention Type: OTHER

Healthy Controls

The investigators will assess and acquire data on these Veterans who do not have history of PTSD and have no history of any Axis I psychiatric disorder, are taking psychotropic medication, or use illicit drugs. They will acquire fMRI, behavioral, EEG, TMS/EEG, and saliva once. All study assessments will take place at Stanford University. Subjects will be recruited through public flying, online ads and VAPAHCS. 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.

No interventions assigned to this group

Interventions

Psychotherapy

Intervention Type: OTHER

Other Intervention Names

Cognitive Processing Therapy; Prolonged Exposure

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Mexico VA Healthcare System

FED

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alan Schatzberg

Kenneth T. Norris, Jr. Professor of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan Schatzberg, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

VA Palo Alto Health Care System (VAPAHCS)

Palo Alto, California, United States

New Mexico VA Health Care System

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

39006

Identifier Type: -

Identifier Source: org_study_id