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Completed

NCT Number: NCT01564667

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University

Omaha, Nebraska, 68178, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attention Bias Modification Training Protocol

Behavioral

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

Primary outcomes

  1. Will Posttraumatic Stress Disorder and Symptom decrease with intervention

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Other psychiatics symptoms (ie Depression, Anger, Anxiety)

    Time frame: 8 weeks

    To assess potential decrease in psychiatric symptoms associated with PTSD, by comparing pre intervention and post intervention scores on psychological measures of deprssion, anger and anxiety.

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • At Ease USA

Registry information

Official study title

Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2012
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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