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Completed

NCT Number: NCT04888169

Studying the Modification of Attention Bias Remotely After Trauma

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).

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tommy Atwater

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMART Mobile App - Attention Bias Modification

Device

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

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.

SMART Mobile App - Placebo Training

Device

Placebo training only includes neutral stimuli.

SMART Mobile App - Control

Device

Participants will only answer questions.

Primary outcomes

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

    Time frame: Baseline, 4 weeks

    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.

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

    Time frame: 4 weeks, 8 Weeks

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco Veterans Affairs Medical Center

Registry information

Official study title

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

Acronym: SMART

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 17, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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