Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 27, 2012
July 14, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
Change in Eye-gaze Tracking [ Time Frame: from Baseline to 6 months ] [ Designated as safety issue: No ]
This measures attentional bias.
Same as current
Complete list of historical versions of study NCT01571245 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Predicting Treatment Response Using Psychophysiologic Reactivity Measures
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. 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Post Traumatic Stress Disorder
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2016
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Tim Kimbrell, MD 501-257-3496 timothy.kimbrell@va.gov
Contact: Jeffrey M Pyne, MD 501-257-1084 jeffrey.pyne@va.gov
United States
 
NCT01571245
252121, PTRUPRM
No
Central Arkansas Veterans Healthcare System
Central Arkansas Veterans Healthcare System
Not Provided
Principal Investigator: John Spollen, MD Central Arkansas Veterans Healthcare System
Central Arkansas Veterans Healthcare System
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP