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

NCT01368302 | Completed Phase 2

• 1 other identifier: 949-2010
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Bias Modification Treatment (ABMT)

Keywords

attention bias modification treatment; cognitive bias modification; attention training; anxiety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• PTSD Check List (PCL)

  10 minutes

Study Arms (2)

Attention Bias Modification (ABM)

EXPERIMENTAL

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

Behavioral: Attention Bias Modification Treatment (ABMT)

Placebo

PLACEBO COMPARATOR

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

Behavioral: Attention Bias Modification Treatment (ABMT)

Interventions

Attention Bias Modification Treatment (ABMT) BEHAVIORAL

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

Attention Bias Modification (ABM); Placebo

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Combat-related PTSD diagnosis

You may not qualify if:

• Other treatment

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, 69978, Israel

Location

Related Publications (2)

• 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.

  PMID: 20887977 BACKGROUND

• 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.

  PMID: 26206075 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 7, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

IL (1)