Clinical trial NCT01723215: Prevention of Combat-related PTSD Using Attention Bias Modification (ABM): A Randomized Controlled Trial
Official title: Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Attention bias modification
resilience
combat
PTSD
Depression
Anxiety
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Medical Corps, Israel Defense Force
name: Walter Reed Army Institute of Research (WRAIR)
First posted: 2012-11-07
Enrollment: 862
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* combat soldiers

Exclusion Criteria:

* Fluent Hebrew

Primary outcomes:
measure: Changes in PTSD symptoms(PCL)
timeFrame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat
measure: Probable PTSD diagnosis(CAPS)
timeFrame: Four months after combat
Secondary outcomes:
measure: Changes in Depression(PHQ-9)) and Anxiety(STAI)
timeFrame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat
Other outcomes:
measure: Attention Bias Scores
timeFrame: Pre-traetment baseline and in deployment
Locations:
city: Beer sheva
country: Israel
facility: IDF Military camps
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mental Health Department IDF
name: Eyal Fruchter
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Wald I, Fruchter E, Ginat K, Stolin E, Dagan D, Bliese PD, Quartana PJ, Sipos ML, Pine DS, Bar-Haim Y. Selective prevention of combat-related post-traumatic stress disorder using attention bias modification training: a randomized controlled trial. Psychol Med. 2016 Sep;46(12):2627-36. doi: 10.1017/S0033291716000945. Epub 2016 Jul 5.