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Studying the Modification of Attention Bias Remotely After Trauma (SMART)

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ClinicalTrials.gov Identifier: NCT04888169
Recruitment Status : Not yet recruiting
First Posted : May 17, 2021
Last Update Posted : May 17, 2021
Sponsor:
Collaborator:
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Device: SMART Mobile App - Attention Bias Modification Device: SMART Mobile App - Attention Control Training Device: SMART Mobile App - Placebo Training Device: SMART Mobile App - Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1897 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Optimizing Attention Bias Modification for Posttraumatic Stress Disorder: An Entirely Remote Study
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Attention Bias Modification - Word Stimuli
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.
Device: SMART Mobile App - Attention Bias Modification
ABM involves placing the probe behind the neutral stimulus on 100% of the trials.

Active Comparator: Attention Bias Modification - Face Stimuli
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.
Device: SMART Mobile App - Attention Bias Modification
ABM involves placing the probe behind the neutral stimulus on 100% of the trials.

Experimental: Attention Control Training - Word Stimuli
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%.
Device: SMART Mobile App - Attention Control Training
ACT involves placing the probe behind the neutral stimulus on 50% of trials, and behind the threat stimulus on 50% of trials.

Active Comparator: Attention Control Training - Face Stimuli
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%.
Device: SMART Mobile App - Attention Control Training
ACT involves placing the probe behind the neutral stimulus on 50% of trials, and behind the threat stimulus on 50% of trials.

Placebo Comparator: Placebo Attention Training - Word Stimuli
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.
Device: SMART Mobile App - Placebo Training
Placebo training only includes neutral stimuli.

Placebo Comparator: Placebo Attention Training - Face Stimuli
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.
Device: SMART Mobile App - Placebo Training
Placebo training only includes neutral stimuli.

Sham Comparator: Control - Questions
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.
Device: SMART Mobile App - Control
Participants will only answer questions.




Primary Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 to 55 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 iOS smartphone running sufficient software (i.e. at least iOS 10.1), and is not willing to update
  • Active suicidality.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04888169


Contacts
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Contact: Aoife O'Donovan, PhD 415-221-4810 ext 24959 Aoife.ODonovan@ucsf.edu
Contact: Joshua Woolley, MD, PhD 415-221-4810 ext 23318 Josh.Woolley@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Lab Manager       paige.tripp@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
Investigators
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Principal Investigator: Joshua Woolley, MD, PhD UCSF, SFVAMC
Principal Investigator: Joaquin Anguera, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04888169    
Other Study ID Numbers: 19-27541
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
Attention bias
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders