Studying the Modification of Attention Bias Remotely After Trauma

Post Traumatic Stress Disorder Clinical Trial

— SMART  

Official title:

Optimizing Attention Bias Modification for Posttraumatic Stress Disorder: An Entirely Remote Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888169
• Other study ID #: 19-27541
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Aoife O'Donovan, PhD
• Phone: 415-221-4810
• Email: Aoife.ODonovan[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1897
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• SMART Mobile App - Attention Bias Modification
ABM involves placing the probe behind the neutral stimulus on 100% of the trials.
• 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.
• SMART Mobile App - Placebo Training
Placebo training only includes neutral stimuli.
• SMART Mobile App - Control
Participants will only answer questions.

Locations

Country	Name	City	State
United States	Zoe Zong	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4 weeks
Primary	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.	4 weeks, 8 Weeks