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

NCT01723215 | Completed

• 1 other identifier: TelAvivU
• Study Type: interventional
• Target: 862
• Locations: 1 country
• Sites: 1

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

Keywords

Attention bias modification; resilience; combat; PTSD; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

• Probable PTSD diagnosis(CAPS)

  Four months after combat

  Four months after combat

Secondary Outcomes (1)

• Changes in Depression(PHQ-9)) and Anxiety(STAI)

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

Other Outcomes (1)

• Attention Bias Scores

  Pre-traetment baseline and in deployment

Study Arms (4)

Active ABMT8

ACTIVE COMPARATOR

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

Behavioral: Active ABMT8

Active ABMT4

ACTIVE COMPARATOR

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

Behavioral: Active ABMT4

Control

NO INTERVENTION

Control: will not receive any intervention

Placebo

PLACEBO COMPARATOR

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

Behavioral: Placebo

Interventions

Active ABMT8 BEHAVIORAL

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

Active ABMT8

Active ABMT4 BEHAVIORAL

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

Active ABMT4

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

Placebo

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• combat soldiers

You may not qualify if:

• Fluent Hebrew

Sponsors & Collaborators

• Tel Aviv University: lead
• Medical Corps, Israel Defense Force: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

IDF Military camps

Beersheba, Israel

Location

Related Publications (3)

• 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.

  PMID: 20456540 BACKGROUND

• 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.

  PMID: 20395400 BACKGROUND

• 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.

  PMID: 27377418 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Yair Bar-Haim, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

• Eyal Fruchter

  Mental Health Department IDF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 7, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

IL (1)