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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564667
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : January 14, 2016
Sponsor:
Collaborator:
At Ease USA
Information provided by (Responsible Party):
Creighton University

Tracking Information
First Submitted Date  ICMJE March 26, 2012
First Posted Date  ICMJE March 28, 2012
Last Update Posted Date January 14, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Will Posttraumatic Stress Disorder and Symptom decrease with intervention [ Time Frame: 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
Posttraumatic Stress Disorder and Symptom Clusters [ Time Frame: 40 minutes ]
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Other psychiatics symptoms (ie Depression, Anger, Anxiety) [ Time Frame: 8 weeks ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
Posttraumatic Stress Disorder Symptoms [ Time Frame: 10 minutes ]
PTSD Check List - Military Version (PCL-M):The 17-item Department of Veterans Affairs PTSD Checklist - Military Version- PCL-M is a check list of DSM-IV symptoms of PTSD (Blanchard, Jones-Alexander, Buckley, & Forneris, 1996; Hoge, 2004; Kang, Natelson, Mahan, Lee, & Murphy, 2003).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)
Official Title  ICMJE Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Attention Bias Modification Treatment
    Attention bias modification training using a computerized spatial attention task (dot-probe) designed to alter threat-bias attention patterns away from threat.
    Intervention: Behavioral: Attention Bias Modification Training Protocol
  • Active Comparator: Attentional Control Training
    Attention control training using a computerized spatial attention taks (dot-probe) counter balances training toward and away from threat.
    Intervention: Behavioral: Attention Bias Modification Training Protocol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2015)
51
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2012)
60
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01564667
Other Study ID Numbers  ICMJE 11-16311
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Creighton University
Study Sponsor  ICMJE Creighton University
Collaborators  ICMJE At Ease USA
Investigators  ICMJE
Principal Investigator: Amy S Badura Brack, PhD Creighton University
PRS Account Creighton University
Verification Date January 2016

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