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Attention Bias Modification for PTSD (SMART Trial)

N/A

Recruiting

Led By Joshua Woolley, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks, 8 weeks

Summary

This trial will compare the effects 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).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive app-based interventions focused on modifying attention patterns related to trauma, there are no direct physical side effects expected from participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks, 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks, 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks, 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Trial Design

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.

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