Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification

Depression Clinical Trial

Official title:

Increasing Psychological Resilience in Combat Soldiers Applying Advanced Eye-Tracking-Based Attention Bias Modification

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05294848
• Other study ID #: TAU-GCFTresilience
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 540
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• PTSD

Intervention

Behavioral:
• Gaze-Contingent Feedback Training
Feedback according to participants' viewing patterns, in order to modify their attention toward threat stimuli.
• Attention Bias Modification
Attention training via repeated trials of a dot-probe task intended to direct attention toward threat stimuli using threat and neutral face stimuli.
• Neutral Control
Dot-probe task using only neutral stimuli with no training toward threat

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-Training RT-based Attention Bias toward threat	Change in Attention Bias will be assessed with a response-time based dot-probe task.	Change from baseline Attention Bias within 6 months of baseline measurement
Other	Post-Training Subjective Attention Bias toward threat	Change in Subjective Attention Bias will be assessed with a self-reported attention bias using the Attention Bias Questionnaire (ABQ). The total score, ranging from 0 to 36, represents threat-related attention bias, with higher scores representing greater bias toward threat.	Change from baseline Attention Bias within 6 months of baseline measurement
Other	Post-Training Eye-tracking Attention Bias toward threat	Change in Attention Bias will also be assessed with an eye-tracking task.	Change from baseline Attention Bias within 6 months of baseline measurement
Primary	Post-Combat PTSD Symptoms	Score on on self-report questionnaire Posttraumatic stress disorder checklist for DSM-5 (PCL-5). The total score, ranging from 0 to 80, reflects PTSD symptom severity, with higher scores representing greater severity.	Change from baseline Post-Combat PTSD Symptoms at approximately 1.5 years
Secondary	Post-Combat General Anxiety	Score on self-report questionnaire Generalized Anxiety Disorder questionnaire (GAD-7). The total score, ranging from 0 to 21, reflects GAD symptom severity, with higher scores representing greater severity.	Change from baseline Post-Combat General Anxiety Symptoms at approximately 1.5 years
Secondary	Post-Combat Depression	Score on self-report Patient Health Questionnaire 9 (PHQ-9). The total score, ranging from 0-27, reflects severity of depressive symptoms, with higher scores representing greater severity	Change from baseline Post-Combat Depression Symptoms at approximately 1.5 years