- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368302
Attention Bias Modification Treatment (ABMT) for Patients With Post Traumatic Stress Disorder (PTSD)
Patients with Post Traumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to normalize threat-related attention biases or a placebo control condition not designed to change attention patterns. Outcome measures will be Post Traumatic Stress Disorder (PTSD), depression, and anxiety symptoms as measured by gold standard questionnaires and symptom counts derived from structured clinical interviews.
We expect to see significant Post Traumatic Stress Disorder symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Tel Aviv, Israel, 69978
- Tel Aviv University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Combat-related PTSD diagnosis
Exclusion Criteria:
- Other treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Attention Bias Modification (ABM)
Attention training via repeated trials of a dot-probe task intended to normalize threat-related attention biases.
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Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
|
|
Placebo Comparator: Placebo
Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.
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Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
Time Frame: 40 minutes
|
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).
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40 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Check List (PCL)
Time Frame: 10 minutes
|
Post-traumatic Stress symptoms will be evaluated using the 17-item National Center for PTSD Checklist of the Department of Veterans Affairs- PCL (Blanchard, Jones-Alexander, Buckley, & Forneris, 1996; Hoge, 2004; Kang, Natelson, Mahan, Lee, & Murphy, 2003).
|
10 minutes
|
Collaborators and Investigators
Sponsor
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
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 949-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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