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

Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Attention Bias Modification Training Protocol

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Creighton University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
ACTIVE_COMPARATOR: Attentional Control Training; Attention control training using a computerized spatial attention taks (dot-probe) counter balances training toward and away from threat.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Will Posttraumatic Stress Disorder and Symptom decrease with intervention	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other psychiatics symptoms (ie Depression, Anger, Anxiety)	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.	8 weeks

Collaborators and Investigators

• Sponsor: Creighton University
• Collaborators: At Ease USA
• Investigators: Principal Investigator: Amy S Badura Brack, PhD, Creighton University

Publications and helpful links

General Publications

• Hakamata Y, Lissek S, Bar-Haim Y, Britton JC, Fox NA, Leibenluft E, Ernst M, Pine DS. Attention bias modification treatment: a meta-analysis toward the establishment of novel treatment for anxiety. Biol Psychiatry. 2010 Dec 1;68(11):982-90. doi: 10.1016/j.biopsych.2010.07.021. Erratum In: Biol Psychiatry. 2012 Sep 1;72(5):429.
• Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (ESTIMATE): March 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2016
• Last Update Submitted That Met QC Criteria: January 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: PTSD; Posttraumatic Stress; Combat; Post Traumatic Stress; Attention Bias; Threat Bias; Warzone
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 11-16311