Studying the Modification of Attention Bias Remotely After Trauma

Not Applicable

Recruiting

• Conditions: Post Traumatic Stress Disorder
• Interventions: Device: SMART Mobile App - Control; Device: SMART Mobile App - Attention Control Training; Device: SMART Mobile App - Attention Bias Modification; Device: SMART Mobile App - Placebo Training

• Registration Number: NCT04888169
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Study Start: 2023-04-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1897

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - Questions	SMART Mobile App - Control	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.
Attention Control Training - Face Stimuli	SMART Mobile App - Attention Control Training	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%.
Attention Bias Modification - Word Stimuli	SMART Mobile App - Attention Bias Modification	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.
Attention Bias Modification - Face Stimuli	SMART Mobile App - Attention Bias Modification	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.
Attention Control Training - Word Stimuli	SMART Mobile App - Attention Control Training	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%.
Placebo Attention Training - Word Stimuli	SMART Mobile App - Placebo Training	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.
Placebo Attention Training - Face Stimuli	SMART Mobile App - Placebo Training	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.

Primary Outcome Measures

Name	Time	Method
Change in PTSD Checklist-5 (PCL) Score (Follow-up)	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.
Change in PTSD Checklist-5 (PCL) Score (Before/After Training)	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.

Trial Locations

Locations (1)

Tommy Atwater; 🇺🇸 San Francisco, California, United States