Studying the Modification of Attention Bias Remotely After Trauma

NCT04888169 | Completed FDA Device

• 1 other identifier: 19-27541
• Study Type: interventional
• Target: 1,314
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Attention bias

Outcome Measures

Primary Outcomes (2)

• Change in PTSD Checklist-5 (PCL) Score (Before/After Training)

  Looking at the change of PCL scores from prior to beginning (baseline) and directly after completing the training at week 4. PCL scores range from 0-80 with a score of 33 indicating clinically significant levels of PTSD. A 10 point change (up or down) is considered a clinically significant change in PTSD symptoms. A PCL score of \<33 indicates non-clinically significant PTSS. A PCL score of \>= 33 indicates clinically significant PTSS.

  Baseline, 4 weeks

• Change in PTSD Checklist-5 (PCL) Score (Follow-up)

  Looking at the change of PCL scores from directly after completing the training at 4 weeks to a follow-up conducted at week 8. PCL scores range from 0-80 with a score of 33 indicating clinically significant levels of PTSD. A 10 point change (up or down) is considered a clinically significant change in PTSD symptoms. A PCL score of \<33 indicates non-clinically significant PTSS. A PCL score of \>= 33 indicates clinically significant PTSS.

  4 weeks, 8 Weeks

Study Arms (7)

Attention Bias Modification - Word Stimuli

EXPERIMENTAL

Attention bias modification training involves a probe detection task as follows: (1) a fixation cross appears on the screen for 500ms; (2) the fixation cross is replaced by two target stimuli (one threat word and one neutral word) that are displayed at the top and the bottom of the screen for 500ms; (2) the stimuli disappear and a visual probe appears (the letter E or F), in the location of one of the two stimuli until the participant responds to indicate whether the letter was an E or an F using response buttons at the bottom of the phone screen. In the active ABM condition, the probe replaces the neutral stimulus 100% of the time.

Device: SMART Mobile App - Attention Bias Modification

Attention Bias Modification - Face Stimuli

ACTIVE COMPARATOR

Attention bias modification training involves a probe detection task as follows: (1) a fixation cross appears on the screen for 500ms; (2) the fixation cross is replaced by two target stimuli (one threatening face and one neutral face) that are displayed at the top and the bottom of the screen for 500ms; (2) the stimuli disappear and a visual probe appears (the letter E or F), in the location of one of the two stimuli until the participant responds to indicate whether the letter was an E or an F using response buttons at the bottom of the phone screen. In the active ABM condition, the probe replaces the neutral stimulus 100% of the time.

Device: SMART Mobile App - Attention Bias Modification

Attention Control Training - Word Stimuli

EXPERIMENTAL

Attention control training involves a probe detection task as follows: (1) a fixation cross appears on the screen for 500ms; (2) the fixation cross is replaced by two target stimuli (i.e. one threat word and one neutral word) that are displayed at the top and the bottom of the screen for 500ms; (2) the stimuli disappear and a visual probe appears (the letter E or F), in the location of one of the two stimuli until the participant responds to indicate whether the letter was an E or an F using response buttons at the bottom of the phone screen. In the active ACT condition, the probe replaces the neutral stimulus 50% of the time, and replaces the threat stimulus the other 50%.

Device: SMART Mobile App - Attention Control Training

Attention Control Training - Face Stimuli

ACTIVE COMPARATOR

Attention control training involves a probe detection task as follows: (1) a fixation cross appears on the screen for 500ms; (2) the fixation cross is replaced by two target stimuli (one threatening face and one neutral face) that are displayed at the top and the bottom of the screen for 500ms; (2) the stimuli disappear and a visual probe appears (the letter E or F), in the location of one of the two stimuli until the participant responds to indicate whether the letter was an E or an F using response buttons at the bottom of the phone screen. In the active ACT condition, the probe replaces the neutral stimulus 50% of the time, and replaces the threat stimulus the other 50%.

Device: SMART Mobile App - Attention Control Training

Placebo Attention Training - Word Stimuli

PLACEBO COMPARATOR

Placebo attention training involves a probe detection task as follows: (1) a fixation cross appears on the screen for 500ms; (2) the fixation cross is replaced by two target stimuli (two neutral words) that are displayed at the top and the bottom of the screen for 500ms; (2) the stimuli disappear and a visual probe appears (the letter E or F), in the location of one of the two stimuli until the participant responds to indicate whether the letter was an E or an F using response buttons at the bottom of the phone screen.

Device: SMART Mobile App - Placebo Training

Placebo Attention Training - Face Stimuli

PLACEBO COMPARATOR

Placebo attention training involves a probe detection task as follows: (1) a fixation cross appears on the screen for 500ms; (2) the fixation cross is replaced by two target stimuli (two neutral faces) that are displayed at the top and the bottom of the screen for 500ms; (2) the stimuli disappear and a visual probe appears (the letter E or F), in the location of one of the two stimuli until the participant responds to indicate whether the letter was an E or an F using response buttons at the bottom of the phone screen.

Device: SMART Mobile App - Placebo Training

Control - Questions

SHAM COMPARATOR

The Control - Questions condition will only deliver a set of daily questions for participants to answer. Questions will ask about a variety of psychological factors such as mood, stress experiences, daily exercise and more.

Device: SMART Mobile App - Control

Interventions

SMART Mobile App - Attention Bias Modification DEVICE

ABM involves placing the probe behind the neutral stimulus on 100% of the trials.

Attention Bias Modification - Face Stimuli; Attention Bias Modification - Word Stimuli

SMART Mobile App - Attention Control Training DEVICE

ACT involves placing the probe behind the neutral stimulus on 50% of trials, and behind the threat stimulus on 50% of trials.

Attention Control Training - Face Stimuli; Attention Control Training - Word Stimuli

SMART Mobile App - Placebo Training DEVICE

Placebo training only includes neutral stimuli.

Placebo Attention Training - Face Stimuli; Placebo Attention Training - Word Stimuli

SMART Mobile App - Control DEVICE

Participants will only answer questions.

Control - Questions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years
• Score at or above 33 on the PCL-5,
• Able and willing to perform daily smartphone training for two weeks
• Fluent English comprehension.
• Owns Android or iPhone smartphone

You may not qualify if:

• Does not have Android or iPhone Operating System (iOS) smartphone running sufficient software (i.e. at least iOS 10.1), and is not willing to update
• Active suicidality.

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (1)

Tommy Atwater

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Joshua Woolley, MD, PhD

  UCSF, SFVAMC

  PRINCIPAL INVESTIGATOR

• Joaquin Anguera, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: April 20, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)