Predicting Treatment Response Using Psychophysiologic Reactivity Measures



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:April 2012
End Date:December 2015

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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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
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North Little Rock, Arkansas 72114
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