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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification Training Protocol
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Posttraumatic Stress, Post Traumatic Stress, Attention Bias, Threat Bias, Combat, Warzone

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Creighton University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Attention Bias Modification Treatment

Attentional Control Training

Arm Description

Attention bias modification training using a computerized spatial attention task (dot-probe) designed to alter threat-bias attention patterns away from threat.

Attention control training using a computerized spatial attention taks (dot-probe) counter balances training toward and away from threat.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 26, 2012
Last Updated
January 13, 2016
Sponsor
Creighton University
Collaborators
At Ease USA
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1. Study Identification

Unique Protocol Identification Number
NCT01564667
Brief Title
Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)
Official Title
Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
At Ease USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Posttraumatic Stress, Post Traumatic Stress, Attention Bias, Threat Bias, Combat, Warzone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Bias Modification Treatment
Arm Type
Experimental
Arm Description
Attention bias modification training using a computerized spatial attention task (dot-probe) designed to alter threat-bias attention patterns away from threat.
Arm Title
Attentional Control Training
Arm Type
Active Comparator
Arm Description
Attention control training using a computerized spatial attention taks (dot-probe) counter balances training toward and away from threat.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification Training Protocol
Intervention Description
Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.
Primary Outcome Measure Information:
Title
Will Posttraumatic Stress Disorder and Symptom decrease with intervention
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Other psychiatics symptoms (ie Depression, Anger, Anxiety)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy S Badura Brack, PhD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20887977
Citation
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.
Results Reference
background
PubMed Identifier
26206075
Citation
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.
Results Reference
derived

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

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