Attention Bias Modification for PTSD
(SMART Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJoshua Woolley, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Trial Summary

What is the purpose of this trial?

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).

Research Team

Joaquin Anguera, PhD

Principal Investigator

University of California, San Francisco

Joshua Woolley, MD, PhD

Principal Investigator

UCSF, SFVAMC

Eligibility Criteria

This trial is for individuals aged 18 to 55 who have significant post-traumatic stress symptoms, as indicated by a score of at least 33 on the PCL-5. Participants must own a smartphone compatible with the study's app and be willing to engage in daily training for two weeks. Those without the required smartphone or current suicidal thoughts cannot participate.

Inclusion Criteria

Aged 18 to 55 years

Able and willing to perform daily smartphone training for two weeks

You have an Android or iPhone smartphone.

See 2 more

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

You are currently having thoughts or plans of hurting yourself.

Treatment Details

Interventions

Attention Bias Modification (Behavioural Intervention)
Attention Control Training (Behavioural Intervention)
Placebo Training (Behavioural Intervention)

Trial OverviewThe study tests four different smartphone-based trainings: attention bias modification, attention control training, placebo neutral attention training, and a control condition involving daily questions. The goal is to see how these affect attention bias and self-reported stress symptoms over eight weeks in nearly 1,900 participants.

Participant Groups

7Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Attention Control Training - Word StimuliExperimental Treatment1 Intervention

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 II: Attention Bias Modification - Word StimuliExperimental Treatment1 Intervention

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 III: Attention Bias Modification - Face StimuliActive Control1 Intervention

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 IV: Attention Control Training - Face StimuliActive Control1 Intervention

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 V: Control - QuestionsPlacebo Group1 Intervention

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 VI: Placebo Attention Training - Face StimuliPlacebo Group1 Intervention

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 VII: Placebo Attention Training - Word StimuliPlacebo Group1 Intervention

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.