Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)
This study is currently recruiting participants.
Verified December 2012 by Creighton University
Sponsor:
Creighton University
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: December 12, 2012
Last verified: December 2012
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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 Behavioral: Placebo |
| 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:
- Posttraumatic Stress Disorder and Symptom Clusters [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- Posttraumatic Stress Disorder Symptoms [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]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).
| 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
Attention Bias Modification computer training 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.
|
Behavioral: Placebo
Placebo computer training program administered 2 times per week for 4 weeks making a total of 8 sessions.
|
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
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: | December 12, 2012 |
| 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 May 16, 2013