Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)

NCT ID: NCT01564667

Last Updated: 2016-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

Brief Summary

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Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension.

The investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Attention Bias Modification Treatment

Attention bias modification training using a computerized spatial attention task (dot-probe) designed to alter threat-bias attention patterns away from threat.

Group Type EXPERIMENTAL

Attention Bias Modification Training Protocol

Intervention Type BEHAVIORAL

Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.

Attentional Control Training

Attention control training using a computerized spatial attention taks (dot-probe) counter balances training toward and away from threat.

Group Type ACTIVE_COMPARATOR

Attention Bias Modification Training Protocol

Intervention Type BEHAVIORAL

Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.

Interventions

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Attention Bias Modification Training Protocol

Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003.

Exclusion Criteria

* Schizophrenia
* Bipolar Disorder
* Obsessive Compulsive Disorder
* Head Injury with Loss of Consciousness for more than 30 minutes
* Active Alcohol/Substance Dependence in past 6 months
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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At Ease USA

UNKNOWN

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy S Badura Brack, PhD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20887977 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26206075 (View on PubMed)

Other Identifiers

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11-16311

Identifier Type: -

Identifier Source: org_study_id

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