Predicting Treatment Response Using Psychophysiologic Reactivity Measures

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72114-1706
      • CAVHS Eugene Towbin VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Veterans receiving or seeking treatment at the Central Arkansas Veterans Healthcare Administration Mental Health Clinics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Eye-gaze Tracking	This measures attentional bias.	from Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Stroop	This measures attentional bias	from Baseline to 6 months
Change in Heart rate variability		from Baseline to 6 months

Collaborators and Investigators

• Sponsor: Central Arkansas Veterans Healthcare System
• Investigators: Principal Investigator: John Spollen, MD, Central Arkansas Veterans Healthcare System

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (Estimate): April 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Heart rate variability; Attentional Bias
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 252121; PTRUPRM (Other Identifier: Central Arkansas Veterans Healthcare System)