Studying the Modification of Attention Bias Remotely After Trauma

NCT ID: NCT04888169

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2025-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Keywords

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Attention bias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Attention Bias Modification - Word Stimuli

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.

Group Type EXPERIMENTAL

SMART Mobile App - Attention Bias Modification

Intervention Type DEVICE

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

Attention Bias Modification - Face Stimuli

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.

Group Type ACTIVE_COMPARATOR

SMART Mobile App - Attention Bias Modification

Intervention Type DEVICE

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

Attention Control Training - Word Stimuli

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%.

Group Type EXPERIMENTAL

SMART Mobile App - Attention Control Training

Intervention Type 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 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%.

Group Type ACTIVE_COMPARATOR

SMART Mobile App - Attention Control Training

Intervention Type DEVICE

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

Placebo Attention Training - Word Stimuli

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.

Group Type PLACEBO_COMPARATOR

SMART Mobile App - Placebo Training

Intervention Type DEVICE

Placebo training only includes neutral stimuli.

Placebo Attention Training - Face Stimuli

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.

Group Type PLACEBO_COMPARATOR

SMART Mobile App - Placebo Training

Intervention Type DEVICE

Placebo training only includes neutral stimuli.

Control - Questions

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.

Group Type SHAM_COMPARATOR

SMART Mobile App - Control

Intervention Type DEVICE

Participants will only answer questions.

Interventions

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SMART Mobile App - Attention Bias Modification

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

Intervention Type 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.

Intervention Type DEVICE

SMART Mobile App - Placebo Training

Placebo training only includes neutral stimuli.

Intervention Type DEVICE

SMART Mobile App - Control

Participants will only answer questions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Francisco Veterans Affairs Medical Center

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Woolley, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF, SFVAMC

Joaquin Anguera, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Tommy Atwater

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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19-27541

Identifier Type: -

Identifier Source: org_study_id