NCT04888169

Studying the Modification of Attention Bias Remotely After Trauma

Optimizing Attention Bias Modification for Posttraumatic Stress Disorder: An Entirely Remote Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,314 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators will complete an entirely remote randomized controlled trial (RCT) comparing 14 sessions of attention bias modification (ABM), attention control training (ACT), placebo neutral attention training, and a final control condition with daily questions in 1,897 individuals with clinically significant Post-traumatic Stress Symptoms (PTSS) (defined as PCL-5 score ≥ 33). To assess effects of the training and control conditions, the investigators will administer tests of threat-related attention bias and variability, and self-report assessments of PTSS, depression, anxiety, and perceived stress at baseline, after one and two weeks of training, and at eight-week follow up. The investigators plan to screen and confirm interest from over 3,000 eligible participants over a period of 24 months to enroll and randomize 1,897 participants with the end goal of 1,232 completers (176 per condition).

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	SMART Mobile App - Attention Bias Modification	ABM involves placing the probe behind the neutral stimulus on 100% of the trials.
DEVICE	SMART Mobile App - Attention Control Training	ACT involves placing the probe behind the neutral stimulus on 50% of trials, and behind the threat stimulus on 50% of trials.
DEVICE	SMART Mobile App - Placebo Training	Placebo training only includes neutral stimuli.
DEVICE	SMART Mobile App - Control	Participants will only answer questions.

Timeline

• Start date: 2023-04-20
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2021-05-17
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study