Post Traumatic Stress Disorder
Conditions
Keywords
Attention bias
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).
Interventions
DEVICESMART Mobile App - Attention Bias Modification
ABM involves placing the probe behind the neutral stimulus on 100% of the trials.
DEVICESMART 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.
DEVICESMART Mobile App - Placebo Training
Placebo training only includes neutral stimuli.
DEVICESMART Mobile App - Control
Participants will only answer questions.
Sponsors
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoshua Woolley, MD, PhD
UCSF, SFVAMC
PRINCIPAL_INVESTIGATORJoaquin Anguera, PhD
University of California, San Francisco
Outcome results
None listed