Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Creighton University
Sponsor:
Collaborator:
At Ease USA
Information provided by (Responsible Party):
Amy Badura Brack, Creighton University
ClinicalTrials.gov Identifier:
NCT01564667
First received: March 26, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension.

The investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment.


Condition Intervention
Posttraumatic Stress Disorder
Behavioral: Attention Bias Modification Training Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Will Posttraumatic Stress Disorder and Symptom decrease with intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Using Clinician-Administered PTSD Scale (CAPS): The clinician-Administered PTSD Scale (CAPS) is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD (Blake, Weathers, Nagy, Kaloupek, Charney, & Keane, 1995) to assess symptoms of PTSD outcome.


Secondary Outcome Measures:
  • Other psychiatics symptoms (ie Depression, Anger, Anxiety) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To assess potential decrease in psychiatric symptoms associated with PTSD, by comparing pre intervention and post intervention scores on psychological measures of deprssion, anger and anxiety.


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention Bias Modification Treatment
Attention training using a computerized spatial attention task (dot-probe) designed to alter threat-bias attention patterns.
Behavioral: Attention Bias Modification Training Protocol
Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.
Placebo Comparator: Placebo
This is a task designed to look like Attention Bias Modification Treatment but without the therapeutic manipulation.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003.

Exclusion Criteria:

  • Schizophrenia
  • Bipolar Disorder
  • Obsessive Compulsive Disorder
  • Head Injury with Loss of Consciousness for more than 30 minutes
  • Active Alcohol/Substance Dependence in past 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: NCT01564667

Contacts
Contact: Amy S Badura Brack, PhD 402-280-1229 PTSD@creighton.edu
Contact: Maya M. Khanna, PhD 402-280-3452 mayakhanna@creighton.edu

Locations
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68178
Contact: Amy S Badura Brack, PhD    402-280-1229    PTSD@creighton.edu   
Sponsors and Collaborators
Creighton University
At Ease USA
Investigators
Principal Investigator: Amy S Badura Brack, PhD Creighton University
  More Information

Publications:
Responsible Party: Amy Badura Brack, Associate Professor of Psychology, Creighton University
ClinicalTrials.gov Identifier: NCT01564667     History of Changes
Other Study ID Numbers: 11-16311
Study First Received: March 26, 2012
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
PTSD
Posttraumatic Stress
Post Traumatic Stress
Attention Bias
Threat Bias
Combat
Warzone

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

ClinicalTrials.gov processed this record on July 26, 2014