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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723215
• Other study ID #: TelAvivU
• Status: Completed
• Phase: N/A
• First received: November 5, 2012
• Last updated: March 17, 2015
• Start date: December 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 862
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 28 Years

Eligibility

Inclusion Criteria:

• combat soldiers

Exclusion Criteria:

• Fluent Hebrew

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Active ABMT8
Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
• Active ABMT4
Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
• Placebo
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

Locations

Country	Name	City	State
Israel	IDF Military camps	Beer sheva

Sponsors (3)

Lead Sponsor	Collaborator
Tel Aviv University	Medical Corps, Israel Defense Force, Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Bar-Haim Y, Holoshitz Y, Eldar S, Frenkel TI, Muller D, Charney DS, Pine DS, Fox NA, Wald I. Life-threatening danger and suppression of attention bias to threat. Am J Psychiatry. 2010 Jun;167(6):694-8. doi: 10.1176/appi.ajp.2009.09070956. Epub 2010 Apr 15. — View Citation

Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. doi: 10.1111/j.1469-7610.2010.02251.x. Epub 2010 May 6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attention Bias Scores	Attention bias scores measured in milliseconds using the dot-probe task	Pre-traetment baseline and in deployment	No
Primary	Changes in PTSD symptoms(PCL)	1. pre-treatment 2.after first deployment 3.10 days after combat 4. 4 months after combat	Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat	No
Primary	Probable PTSD diagnosis(CAPS)	Four months after combat	Four months after combat	No
Secondary	Changes in Depression(PHQ-9)) and Anxiety(STAI)	1. Pre-treatment(baseline) 2.after first deployment 3.10 days after combat 4. 4 months after combat	Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat	No