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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01368302
Other study ID # 949-2010
Secondary ID
Status Completed
Phase Phase 2
First received May 31, 2011
Last updated December 1, 2014
Start date July 2011
Est. completion date March 2013

Study information

Verified date December 2014
Source Tel Aviv University
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Combat-related PTSD diagnosis

Exclusion Criteria:

- Other treatment

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Attention Bias Modification Treatment (ABMT)
Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.

Locations

Country Name City State
Israel Tel Aviv University Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 40 minutes No
Secondary PTSD Check List (PCL) 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 No