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

• Sponsor: Tel Aviv University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01368302
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Attention Bias Modification Treatment (ABMT)	Behavioral: Attention Bias Modification Treatment (ABMT)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Attention Bias Modification Treatment (ABMT) for Patients With Post Traumatic Stress Disorder (PTSD)
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

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.	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.

Outcome Measures

Primary Outcome Measures

1. Clinician-Administered PTSD Scale (CAPS) [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).

Secondary Outcome Measures

1. PTSD Check List (PCL) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Combat-related PTSD diagnosis

Exclusion Criteria:

• Other treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tel Aviv University	Tel Aviv		Israel	69978

Sponsors and Collaborators

• Tel Aviv University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Yair Bar-Haim, Professor, Tel Aviv University
• ClinicalTrials.gov Identifier: NCT01368302
• Other Study ID Numbers: 949-2010
• First Posted: Jun 7, 2011
• Last Update Posted: Dec 2, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Yair Bar-Haim, Professor, Tel Aviv University: attention bias modification treatment; cognitive bias modification; attention training; anxiety
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Dec 2, 2014