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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Tommy Atwater
San Francisco, California 94143
Contact:
Tommy Atwater
thrivesmartstudy@ucsf.edu

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

Aoife O'Donovan, PhD
415-221-4810
Aoife.ODonovan@ucsf.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.