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Predicting Treatment Response Using Psychophysiologic Reactivity Measures

This study is not yet open for participant recruitment.
Verified April 2012 by Central Arkansas Veterans Healthcare System
Sponsor:
Information provided by (Responsible Party):
John Spollen, Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01571245
First received: March 27, 2012
Last updated: April 3, 2012
Last verified: April 2012
History of Changes
  Purpose

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. We will divide psychophysiologic reactivity predictors into two groups: heart rate variability and attentional bias (eye gaze tracking and modified Stroop). We 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
Post Traumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Treatment Response Using Psychophysiologic Reactivity Measures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Central Arkansas Veterans Healthcare System:

Primary Outcome Measures:
  • Change in Eye-gaze Tracking [ Time Frame: from Baseline to 6 months ] [ Designated as safety issue: No ]
    This measures attentional bias.


Secondary Outcome Measures:
  • Change in Modified Stroop [ Time Frame: from Baseline to 6 months ] [ Designated as safety issue: No ]
    This measures attentional bias

  • Change in Heart rate variability [ Time Frame: from Baseline to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • OEF/OIF/OND veterans
  • Ages 18 to 60 (We 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 we have difficulty locating them 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571245

Contacts
Contact: John Spollen, MD 501-257-3478 john.spollen@va.gov
Contact: Jeffrey M Pyne, MD 501-257-1084 jeffrey.pyne@va.gov

Locations
United States, Arkansas
CAVHS Eugene Towbin VA Medical Center Not yet recruiting
North Little Rock, Arkansas, United States, 72114-1706
Contact: Susan M Jegley, LMSW     501-257-1731     sugan.jegley@va.gov    
Contact: Valorie M Shue, BA     501-257-1457     valorie.shue@va.gov    
Principal Investigator: John Spollen, MD            
Sub-Investigator: Jeffrey M Pyne, MD            
Sub-Investigator: Timothy A Kimbrell, MD            
Sub-Investigator: Dinesh Mittal, MD            
Sponsors and Collaborators
John Spollen
Investigators
Principal Investigator: John Spollen, MD Central Arkansas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: John Spollen, Associate Chief of Staff for Mental Health, Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01571245     History of Changes
Other Study ID Numbers: 252121, PTRUPRM
Study First Received: March 27, 2012
Last Updated: April 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Central Arkansas Veterans Healthcare System:
Heart rate variability
Attentional Bias

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013