Clinical trial NCT05294848: Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification
Official title: Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Depression
Anxiety Disorders
Keywords: Attention Bias Modification
Eye-tracking
Randomized Control Trial
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 501
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel random assignment to 3 arms in 1:1:1 ratio.
Primary purpose: PREVENTION

Brief summary: Military service in combat units entails exposure to traumatic events that require mental adjustment. To develop and efficiently apply attention bias modification interventions aimed at enhancing soldiers' mental resilience, it is essential to test the efficiency of such training programs in RCTs. The purpose of the current study is to examine the efficiency of a new attention eye-tracking-based training protocol, in comparison to an RT-based training protocol, and to a control group, in reducing risk for post-trauma symptoms in combat deployed soldiers.

Detailed description: Following the explanation to participants regarding the study process, those who give written consent to participate will be randomly placed into one of three groups: GCFT (N=180), ABMT (N=180), and a neutral control group - RT-based task (N=180). The study will include 3 measurement points: before attention training (in basic training before deployment), after attention training (in basic training camp, still before deployment), and after a combat deployment cycle (6-12 months - to be determined based on the military deployment mission of the participants). In each measurement point, the participants will complete computerized tasks to measure attention and will complete self-report questionnaires.

Eligibility criteria: Inclusion Criteria:

* Each soldier from the allocated cohort who gives written consent will be able to participate in the study.

Exclusion Criteria:

* Hebrew proficiency is insufficient to complete the study questionnaires.

Primary outcomes:
measure: Post-Combat PTSD Symptoms
timeFrame: Change from baseline Post-Combat PTSD Symptoms at approximately 1.5 years
Secondary outcomes:
measure: Post-Combat General Anxiety
timeFrame: Change from baseline Post-Combat General Anxiety Symptoms at approximately 1.5 years
measure: Post-Combat Depression
timeFrame: Change from baseline Post-Combat Depression Symptoms at approximately 1.5 years
Other outcomes:
measure: Post-Training RT-based Attention Bias toward threat
timeFrame: Change from baseline Attention Bias within 6 months of baseline measurement
measure: Post-Training Subjective Attention Bias toward threat
timeFrame: Change from baseline Attention Bias within 6 months of baseline measurement
measure: Post-Training Eye-tracking Attention Bias toward threat
timeFrame: Change from baseline Attention Bias within 6 months of baseline measurement
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.