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Attention Bias Modification Treatment for Patients With Post Traumatic Stress Disorder (PTSD)

This study is currently recruiting participants.
Verified December 2011 by Tel Aviv University
Sponsor:
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01368302
First received: May 31, 2011
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Attention Bias Modification Treatment (ABMT)
 Behavioral: Attention Bias Modification Treatment (ABMT)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Attention Bias Modification Treatment for Patients With Post Traumatic Stress Disorder (PTSD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel Aviv University:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    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:
  • PTSD Check List (PCL) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention Bias Modification (ABM)
Attention training via repeated trials of a dot-probe task intended to normalize threat-related attention biases.
 Behavioral: Attention Bias Modification Treatment (ABMT)
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.
 Behavioral: Attention Bias Modification Treatment (ABMT)
Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Combat-related PTSD diagnosis

Exclusion Criteria:

  • Other treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368302

Contacts
Contact: Yair Bar-Haim, PhD 972-3-6405465 yair1@post.tau.ac.il
Contact: Reut Naim, MA 972-54-6570555 reutnaim@post.tau.ac.il

Locations
Israel
Tel Aviv University Recruiting
Tel Aviv, Israel, 69978
Principal Investigator: Yair Bar-Haim, PhD            
Principal Investigator: Eyal Fruchter, MD            
Sponsors and Collaborators
Tel Aviv University
  More Information

Publications:

Responsible Party: Yair Bar-Haim, Professor, Tel Aviv University
ClinicalTrials.gov Identifier: NCT01368302     History of Changes
Other Study ID Numbers: 949-2010
Study First Received: May 31, 2011
Last Updated: December 29, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel Aviv University:
attention bias modification treatment
cognitive bias modification
attention training
anxiety

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013