Predicting Treatment Response Using Psychophysiologic Reactivity Measures
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|ClinicalTrials.gov Identifier: NCT01571245|
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : December 15, 2015
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.
|Condition or disease|
|Post Traumatic Stress Disorder|
All subjects will complete a baseline assessment including self-report data and psychophysiologic reactivity measures. Trained research assistants will collect psychophysiologic reactivity data. The investigators will collect the 3-month data in-person. At 6-months, self-report data will be collected in-person. If study participant is unable to complete the 6-month assessment in person the investigators will attempt to collect the self-report data by phone. The study instruments have all been previously administered by telephone. The project coordinator will schedule and track the participants using the telephone. The project coordinator will call participants to remind them about follow-up appointments. The consent form will also include the name and phone number of at least one contact person.
Psychophysiologic reactivity measures will be collected first to minimize fatigue. In addition, the psychophysiologic reactivity measures are context dependent and the investigators do not want the psychophysiologic measures to be primed by symptom reporting. Heart rate variability data will be collected at baseline for five minutes prior to other testing and then continued during eye gaze tracking and modified Stroop testing.
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||Predicting Treatment Response Using Psychophysiologic Reactivity Measures|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Veterans with PTSD
Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) veterans who are ages 18 to 60 and currently in or about to start treatment for deployment-related Post-Traumatic Stress Disorder (PTSD) at the Central Arkansas Veterans Healthcare System Mental Health Clinics.
- Change in Eye-gaze Tracking [ Time Frame: from Baseline to 6 months ]This measures attentional bias.
- Change in Modified Stroop [ Time Frame: from Baseline to 6 months ]This measures attentional bias
- Change in Heart rate variability [ Time Frame: from Baseline to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571245
|United States, Arkansas|
|CAVHS Eugene Towbin VA Medical Center|
|North Little Rock, Arkansas, United States, 72114-1706|
|Principal Investigator:||John Spollen, MD||Central Arkansas Veterans Healthcare System|