NCT01564667

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

March 26, 2012

Last Update Submit

January 13, 2016

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDPosttraumatic StressPost Traumatic StressAttention BiasThreat BiasCombatWarzone

Outcome Measures

Primary Outcomes (1)

  • Will Posttraumatic Stress Disorder and Symptom decrease with intervention

    Using 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) to assess symptoms of PTSD outcome.

    8 weeks

Secondary Outcomes (1)

  • Other psychiatics symptoms (ie Depression, Anger, Anxiety)

    8 weeks

Study Arms (2)

Attention Bias Modification Treatment

EXPERIMENTAL

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

Behavioral: Attention Bias Modification Training Protocol

Attentional Control Training

ACTIVE COMPARATOR

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

Behavioral: Attention Bias Modification Training Protocol

Interventions

Attention Bias Modification Training ProtocolBEHAVIORAL

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

Attention Bias Modification TreatmentAttentional Control Training

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

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: 20887977BACKGROUND

  • 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: 26206075DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Amy S Badura Brack, PhD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

US(1)