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Completed

NCT Number: NCT01723215

Prevention of Combat-related PTSD Using Attention Bias Modification (ABM): A Randomized Controlled Trial

Military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. Decades of scientific research on the origins of resilience and vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing and protective factors. All these factors however, offer limited opportunity for systematic pre-deployment prevention efforts. Considering the magnitude of psychological adjustment difficulties encountered by combat personnel in deployment and the limited access to existing evidence-based therapies for PTSD, the development and testing of a novel evidence-based and theory-driven prevention protocol for these problems is of considerable significance. The current study translates cognitive-neuroscience knowledge and attention bias modification research into a novel computerized training tool that could be easily delivered to soldiers during different stages of the deployment cycle. If proved efficacious in reducing risk for posttraumatic symptoms ABMT could be integrated into the Army's resilience training program. Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers. We will assess attention bias and symptoms before deployment, will randomly assign soldiers to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training. Following 6 months of deployment to combat zone symptoms will be assessed again.

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Key information

Age range

18 year–28 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

IDF Military camps

Beersheba, Israel

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • combat soldiers

Exclusion criteria

  • Fluent Hebrew

Treatment and study plan

Active ABMT8

Behavioral

Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance

Active ABMT4

Behavioral

Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance

Placebo

Behavioral

Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns

Primary outcomes

  1. Changes in PTSD symptoms(PCL)

    Time frame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat

    • pre-treatment 2.after first deployment 3.10 days after combat 4. 4 months after combat
  2. Probable PTSD diagnosis(CAPS)

    Time frame: Four months after combat

    Four months after combat

Secondary outcomes

  1. Changes in Depression(PHQ-9)) and Anxiety(STAI)

    Time frame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat

    • Pre-treatment(baseline) 2.after first deployment 3.10 days after combat 4. 4 months after combat

Other outcomes

  1. Attention Bias Scores

    Time frame: Pre-traetment baseline and in deployment

    Attention bias scores measured in milliseconds using the dot-probe task

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

  • Medical Corps, Israel Defense Force
  • Walter Reed Army Institute of Research (WRAIR)

Registry information

Official study title

Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2012
Registry last updated
Mar 19, 2015

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

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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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