Biomarker Establishment for Superior Treatment of PTSD

NCT03343028 | Completed DMC

• 1 other identifier: 39006
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 2

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

Keywords

veterans; post traumatic stress disorder; depression

Outcome Measures

Primary Outcomes (1)

• Understanding the brain network function-neuroimaging and behavioral with Clinician-Administered PTSD Scale for DSM-5

  We will be using CAPS 5

  Approximately 3 months

Study Arms (2)

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.

Other: Psychotherapy

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.

Interventions

Psychotherapy OTHER

Also known as: Cognitive Processing Therapy, Prolonged Exposure

Psychotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• New Mexico VA Healthcare System: collaborator

Study Sites (2)

VA Palo Alto Health Care System (VAPAHCS)

Palo Alto, California, 94304, United States

Location

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Alan Schatzberg, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kenneth T. Norris, Jr. Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 17, 2017
• Study Start: September 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)