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

NCT ID: NCT01723215

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-02-28

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active ABMT8

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

Group Type: ACTIVE_COMPARATOR

Active ABMT8

Intervention Type: BEHAVIORAL

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

Group Type: ACTIVE_COMPARATOR

Active ABMT4

Intervention Type: BEHAVIORAL

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

Control

Control: will not receive any intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

Active ABMT8

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

Intervention Type: BEHAVIORAL

Active ABMT4

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• combat soldiers

Exclusion Criteria

• Fluent Hebrew

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Corps, Israel Defense Force

OTHER

Sponsor Role: collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: collaborator

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Yair Bar-Haim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yair Bar-Haim, PhD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Eyal Fruchter

Role: PRINCIPAL_INVESTIGATOR

Mental Health Department IDF

Locations

IDF Military camps

Beersheba, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 20456540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20395400 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27377418 (View on PubMed)

Other Identifiers

TelAvivU

Identifier Type: -

Identifier Source: org_study_id