Studying the Modification of Attention Bias Remotely After Trauma

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

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.

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center

  collaborator FED

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Joshua Woolley, MD, PhD · UCSF, SFVAMC

• Joaquin Anguera, PhD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-20

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Device

Yes

Countries

• United States

Study Locations