Predicting Treatment Response Using Psychophysiologic Reactivity Measures

Completed

Conditions studied: Post Traumatic Stress Disorder

In brief

Objective psychophysiologic reactivity data may be useful for predicting post-traumatic stress disorder (PTSD) treatment response. Given the variety of PTSD treatments and the lack of a clearly superior treatment, a reliable and valid approach to predicting treatment response is needed. Specific Aims: 1). Evaluate the clinical utility of psychophysiologic reactivity measures to predict overall PTSD symptom response among OEF/OIF/OND (Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn) veterans receiving treatment for PTSD. 2). Evaluate the clinical utility of psychophysiologic reactivity measures to predict psychosocial functioning and health-related quality of life (HRQoL) response among OEF/OIF/OND veterans in treatment for PTSD. Exploratory). Develop psychophysiologic, neuropsychological, and/or self-report models to predict PTSD symptom response to pharmacotherapy, psychotherapy, and combined pharmacotherapy/psychotherapy. The investigators will divide psychophysiologic reactivity predictors into two groups: heart rate variability and attentional bias (eye gaze tracking and modified Stroop). The investigators will collect observational and longitudinal data from a treatment-seeking sample of 50 OEF/OIF/OND veterans with PTSD recruited from the Central Arkansas Veterans Healthcare System (CAVHS) Mental Health Clinics.

Key facts

Study ID

NCT01571245

Run by

Central Arkansas Veterans Healthcare System

People needed

9

Starts

2012-04-01

Expected to finish

2015-12-01

Last updated by the study team

2015-12-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• OEF/OIF/OND Veterans
• Ages 18 to 60 (The investigators chose to limit the recruitment age to 60 because heart rate variability decreases dramatically with age and therefore may not demonstrate the variability necessary for use in a prediction model.)
• Currently in or about to start treatment for deployment-related PTSD at Mental Health Clinics
• PTSD symptom severity score using the PTSD Checklist-Civilian version of 40 or greater
• Able to provide the name and phone number of at least one contact person in case of difficulty locating participant for the follow-up assessment.

You may not qualify if…

• Current diagnosis of schizophrenia
• Daily use of benzodiazepines except as needed for sleep,
• Daily use of beta-blockers
• Plans to leave the area within 6 months.

Where it is running

• CAVHS Eugene Towbin VA Medical Center — North Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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