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

Primary Purpose

Attention Bias Modification Treatment (ABMT)

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Attention Bias Modification Treatment (ABMT)

About this trial

This is an interventional basic science trial for Attention Bias Modification Treatment (ABMT) focused on measuring attention bias modification treatment, cognitive bias modification, attention training, anxiety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Combat-related PTSD diagnosis

Exclusion Criteria:

Other treatment

Sites / Locations

Tel Aviv University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Attention Bias Modification (ABM)

Placebo

Arm Description

Attention training via repeated trials of a dot-probe task intended to normalize threat-related attention biases.

Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.

Outcomes

Primary Outcome Measures

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

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).

Full Information

NCT ID

NCT01368302

First Posted

May 31, 2011

Last Updated

December 1, 2014

Sponsor

Tel Aviv University

1. Study Identification

Unique Protocol Identification Number

NCT01368302

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tel Aviv University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Bias Modification Treatment (ABMT)

Keywords

attention bias modification treatment, cognitive bias modification, attention training, anxiety

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Attention Bias Modification (ABM)

Arm Type

Experimental

Arm Description

Attention training via repeated trials of a dot-probe task intended to normalize threat-related attention biases.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns.

Intervention Type

Behavioral

Intervention Name(s)

Attention Bias Modification Treatment (ABMT)

Intervention Description

Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.

Primary Outcome Measure Information:

Title

Clinician-Administered PTSD Scale (CAPS)

Description

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).

Time Frame

40 minutes

Secondary Outcome Measure Information:

Title

PTSD Check List (PCL)

Description

Time Frame

10 minutes

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Combat-related PTSD diagnosis Exclusion Criteria: Other treatment

Facility Information:

Facility Name

Tel Aviv University

City

Tel Aviv

ZIP/Postal Code

69978

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

20887977

Citation

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.

Results Reference

background

PubMed Identifier

26206075

Citation

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.

Results Reference

derived

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

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