NCT01571245

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

3.7 years

First QC Date

March 27, 2012

Last Update Submit

December 14, 2015

Conditions

Post Traumatic Stress Disorder

Keywords

Heart rate variabilityAttentional Bias

Outcome Measures

Primary Outcomes (1)

  • Change in Eye-gaze Tracking

    This measures attentional bias.

    from Baseline to 6 months

Secondary Outcomes (2)

  • Change in Modified Stroop

    from Baseline to 6 months

  • Change in Heart rate variability

    from Baseline to 6 months

Study Arms (1)

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 Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAVHS Eugene Towbin VA Medical Center

North Little Rock, Arkansas, 72114-1706, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • John Spollen, MD

    Central Arkansas Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2012

First Posted

April 5, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

US(1)