Attention Bias Modification for PTSD

(SMART Trial)

Recruiting at 2 trial locations

Overseen By Joshua Woolley, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: No smartphone, Active suicidality

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

1897 Participants Needed

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

Able and willing to perform daily smartphone training for two weeks

You have an Android or iPhone smartphone.

You have a score of 33 or higher on a posttraumatic stress disorder (PTSD) checklist.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

24 months

Treatment

Participants undergo 14 sessions of attention bias modification (ABM), attention control training (ACT), placebo neutral attention training, or a control condition with daily questions

4 weeks

Follow-up

Participants are monitored for changes in PTSD symptoms and other psychological factors

4 weeks

Long-term Follow-up

Participants are assessed for sustained changes in PTSD symptoms at 8 weeks

4 weeks

Treatment Details

Interventions

• Attention Bias Modification
• Attention Control Training
• Placebo Training

Trial Overview The 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

Group I: Attention Control Training - Word Stimuli Experimental Treatment 1 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 Stimuli Experimental Treatment 1 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 Stimuli Active Control 1 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 Stimuli Active Control 1 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 - Questions Placebo Group 1 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 Stimuli Placebo Group 1 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 Stimuli Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

San Francisco Veterans Affairs Medical Center

Collaborator

Trials

52

Recruited

211,000+