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NCT01571245 Clinical Trial

Predicting Treatment Response Using Psychophysiologic Reactivity Measures

Post Traumatic Stress Disorder Clinical Trial

Official title:
Predicting Treatment Response Using Psychophysiologic Reactivity Measures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01571245
Other study ID # 252121
Secondary ID PTRUPRM
Status Completed
Phase N/A
First received March 27, 2012
Last updated December 14, 2015
Start date April 2012
Est. completion date December 2015

Study information
Verified date December 2015
Source Central Arkansas Veterans Healthcare System
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States CAVHS Eugene Towbin VA Medical Center North Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Central Arkansas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Eye-gaze Tracking This measures attentional bias. from Baseline to 6 months No
Secondary Change in Modified Stroop This measures attentional bias from Baseline to 6 months No
Secondary Change in Heart rate variability from Baseline to 6 months No
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