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Predicting Treatment Response Using Psychophysiologic Reactivity Measures

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Central Arkansas Veterans Healthcare System
Sponsor:
Information provided by (Responsible Party):
Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01571245
First received: March 27, 2012
Last updated: July 14, 2014
Last verified: July 2014
  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:


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 2016
Estimated Primary Completion Date: April 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571245

Contacts
Contact: Tim Kimbrell, MD 501-257-3496 timothy.kimbrell@va.gov
Contact: Jeffrey M Pyne, MD 501-257-1084 jeffrey.pyne@va.gov

Locations
United States, Arkansas
CAVHS Eugene Towbin VA Medical Center Recruiting
North Little Rock, Arkansas, United States, 72114-1706
Contact: Susan M Jegley, LMSW    501-257-1731    sugan.jegley@va.gov   
Principal Investigator: Tim Kimbrell, MD         
Sub-Investigator: Jeffrey M Pyne, MD         
Sub-Investigator: John Spollen, MD         
Sub-Investigator: Dinesh Mittal, MD         
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
Investigators
Principal Investigator: John Spollen, MD Central Arkansas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: 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: July 14, 2014
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 November 25, 2014