fMRI Predictors of Treatment Response in Posttraumatic Stress Disorder (PTSD)

NCT01576510 | Completed

• 1 other identifier: 2R01MH072833-04A2
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

To employ a fear learning-extinction paradigm with functional magnetic resonance imaging (fMRI) and skin conductance response (SCR) assessments among patients with posttraumatic stress disorder (PTSD) and trauma exposed healthy controls, aiming to a) clarify neural circuits underlying PTSD and b) to probe brain based predictors of symptomatic improvement in response to Prolonged Exposure (PE) treatment, and first line treatment for PTSD.

Conditions

Posttraumatic Stress Disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

• Change over time in Clinician Administered PTSD Scale (CAPS)

  Structured Interview

  Baseline, week 7, week 10, and 3 month follow up

Secondary Outcomes (1)

• Change over time in brain activation patterns as measured by fMRI

  Baseline and 10 weeks (post treatment)

Study Arms (2)

Prolonged Exposure (PE) treatment.

EXPERIMENTAL

Behavioral: Prolonged Exposure (PE)

Trauma exposed healthy controls

NO INTERVENTION

Clinical assessments at baseline, 7 and 10 weeks. fMRI assessments at baseline and 10 weeks.

Interventions

Prolonged Exposure (PE) BEHAVIORAL

Prolonged Exposure (PE) therapy consists of ten 90-minute sessions. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation. The therapist helps the patient cognitively restructure his/her experience of the traumatic event. Each week the narrative is elaborated, becoming more detailed and exhaustive, until the patient habituates to it, extinguishing the anxiety it formerly aroused.

Prolonged Exposure (PE) treatment.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females between the ages of 18 and 60
• Current DSM-IV PTSD
• CAPS score equal or greater than 50.
• Able to give consent, fluent in English or Spanish.

You may not qualify if:

• Depression which is antecedent to PTSD; score of \> 25 on the Hamilton Rating Scale for Depression (HAM-D-17-item); significant depression and /or depression related impairment that is judged to warrant pharmacotherapy or combined medication and psychotherapy.
• Individuals at risk for suicide based on history and current mental state.
• History of substance/alcohol dependence within the past six months, and abuse within past two months
• Patients who are receiving effective medication for their PTSD and/or depression
• Pregnancy, or plans to become pregnant during the period of the study.
• Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body.
• Formal CBT psychotherapy initiated within 3 months of beginning this study.
• Medical illness that could interfere with assessment of diagnosis, treatment response or biological measures (SCR, fMRI), including organic brain impairment from stroke, CNS tumor, or demyelinating disease; and renal, thyroid, hematologic or hepatic impairment
• Current unstable or untreated medical illness, and resting SBP≥140 and DBP≥90 and HR\<60 and HR\>100
• Any condition that would exclude clinical MR exam (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
• Significant claustrophobia that would preclude ability to remain calm within the MRI scanner

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead
• Harvard University: collaborator
• University of Colorado, Boulder: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• Trauma and PTSD Program at New York State psychiatric Institute

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Yuval Neria, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psyhcology

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: August 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

US (1)