Predicting Treatment Response Using Psychophysiologic Reactivity Measures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01571245
First received: March 27, 2012
Last updated: December 14, 2015
Last verified: December 2015
  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. 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.


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 ]

Enrollment: 9
Study Start Date: April 2012
Study Completion Date: December 2015
Primary Completion Date: December 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.

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.

  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 (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.
  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

Locations
United States, Arkansas
CAVHS Eugene Towbin VA Medical Center
North Little Rock, Arkansas, United States, 72114-1706
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
Investigators
Principal Investigator: John Spollen, MD Central Arkansas Veterans Healthcare System
  More Information

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: December 14, 2015
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
Mental Disorders
Trauma and Stressor Related Disorders

ClinicalTrials.gov processed this record on May 26, 2016