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

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART Mobile App - Attention Bias Modification
SMART Mobile App - Attention Control Training
SMART Mobile App - Placebo Training
SMART Mobile App - Control
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Traumatic Stress Disorder focused on measuring Attention bias

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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 iPhone Operating System (iOS) smartphone running sufficient software (i.e. at least iOS 10.1), and is not willing to update
  • Active suicidality.

Sites / Locations

  • Zoe ZongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Placebo Comparator

Placebo Comparator

Sham Comparator

Arm Label

Attention Bias Modification - Word Stimuli

Attention Bias Modification - Face Stimuli

Attention Control Training - Word Stimuli

Attention Control Training - Face Stimuli

Placebo Attention Training - Word Stimuli

Placebo Attention Training - Face Stimuli

Control - Questions

Arm Description

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 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 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%.

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%.

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 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 11, 2021
Last Updated
August 10, 2023
Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04888169
Brief Title
Studying the Modification of Attention Bias Remotely After Trauma
Acronym
SMART
Official Title
Optimizing Attention Bias Modification for Posttraumatic Stress Disorder: An Entirely Remote Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Attention bias

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1897 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attention Bias Modification - Word Stimuli
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Bias Modification - Face Stimuli
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Attention Control Training - Word Stimuli
Arm Type
Experimental
Arm Description
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%.
Arm Title
Attention Control Training - Face Stimuli
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Placebo Attention Training - Word Stimuli
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Placebo Attention Training - Face Stimuli
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control - Questions
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SMART Mobile App - Attention Bias Modification
Intervention Description
ABM involves placing the probe behind the neutral stimulus on 100% of the trials.
Intervention Type
Device
Intervention Name(s)
SMART Mobile App - Attention Control Training
Intervention Description
ACT involves placing the probe behind the neutral stimulus on 50% of trials, and behind the threat stimulus on 50% of trials.
Intervention Type
Device
Intervention Name(s)
SMART Mobile App - Placebo Training
Intervention Description
Placebo training only includes neutral stimuli.
Intervention Type
Device
Intervention Name(s)
SMART Mobile App - Control
Intervention Description
Participants will only answer questions.
Primary Outcome Measure Information:
Title
Change in PTSD Checklist-5 (PCL) Score (Before/After Training)
Description
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.
Time Frame
Baseline, 4 weeks
Title
Change in PTSD Checklist-5 (PCL) Score (Follow-up)
Description
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.
Time Frame
4 weeks, 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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 iPhone Operating System (iOS) smartphone running sufficient software (i.e. at least iOS 10.1), and is not willing to update Active suicidality.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aoife O'Donovan, PhD
Phone
415-221-4810
Ext
24959
Email
Aoife.ODonovan@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Woolley, MD, PhD
Phone
415-221-4810
Ext
23318
Email
Josh.Woolley@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Woolley, MD, PhD
Organizational Affiliation
UCSF, SFVAMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joaquin Anguera, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zoe Zong
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Zong
Email
zoe.zong@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Studying the Modification of Attention Bias Remotely After Trauma

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