Post Traumatic Stress DisorderSMARTNCT04888169
Studying the Modification of Attention Bias Remotely After Trauma
A study testing SMART Mobile App - Attention Bias Modification in people with Post Traumatic Stress Disorder, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- SMART Mobile App - Attention Bias Modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 872 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Attention Bias Modification for Posttraumatic Stress Disorder: An Entirely Remote Study
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).
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- SMART Mobile App - Attention Bias Modification, SMART Mobile App - Attention Control Training, SMART Mobile App - Placebo Training, SMART Mobile App - Control
- Keywords
- Attention bias
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART Mobile App - Attention Bias ModificationDevice
ABM involves placing the probe behind the neutral stimulus on 100% of the trials.
SMART Mobile App - Attention Control TrainingDevice
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 TrainingDevice
Placebo training only includes neutral stimuli.
SMART Mobile App - ControlDevice
Participants will only answer questions.
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification - Word Stimuli | Experimental | 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. Receives: Device: SMART Mobile App - Attention Bias Modification |
| Attention Bias Modification - Face Stimuli | Active comparator | 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. Receives: Device: SMART Mobile App - Attention Bias Modification |
| Attention Control Training - Word Stimuli | Experimental | 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%. Receives: Device: SMART Mobile App - Attention Control Training |
| Attention Control Training - Face Stimuli | Active comparator | 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%. Receives: Device: SMART Mobile App - Attention Control Training |
| Placebo Attention Training - Word Stimuli | Placebo comparator | 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. Receives: Device: SMART Mobile App - Placebo Training |
| Placebo Attention Training - Face Stimuli | Placebo comparator | 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. Receives: Device: SMART Mobile App - Placebo Training |
| Control - Questions | Sham comparator | 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. Receives: Device: SMART Mobile App - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Checklist-5 (PCL) Score (Before/After Training)
Reported are the changes in the PTSD Checklist for the DSM-5 (PCL-5) scores between baseline (Day 1) and post-training (Day 28) in each group. The PCL-5 assesses the presence and severity of 20 different symptoms in posttraumatic stress disorder (PTSD). Each of the 20 items is scored on a severity range of 0 ("Not at All") to 4 ("Extremely"), for a final score range of 0 - 80. A score of 33 and above is indicative of clinically significant PTSD symptoms. Higher scores indicate worse PTSD symptom severity. A 10 point change (up or down) is considered a clinically significant change in PTSD symptoms.
Measured: Baseline, 4 weeks
Change in PTSD Checklist-5 (PCL) Score (Follow-up)
Reported are the changes in the PTSD Checklist for the DSM-5 (PCL-5) scores between post-training (Day 28) and follow-up (Day 56) in each group. The PCL-5 assesses the presence and severity of 20 different symptoms in posttraumatic stress disorder (PTSD). Each of the 20 items is scored on a severity range of 0 ("Not at All") to 4 ("Extremely"), for a final score range of 0 - 80. A score of 33 and above is indicative of clinically significant PTSD symptoms. Higher scores indicate worse PTSD symptom severity. A 10 point change (up or down) is considered a clinically significant change in PTSD symptoms.
Measured: 4 weeks, 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start20 Apr 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 872 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Joshua Woolley, MD, PhD, Principal investigator, UCSF, SFVAMCJoaquin Anguera, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888169
- Sponsor's protocol ID
- 19-27541
- Acronym
- SMART
- Status last verified
- Oct 2026
- First submitted
- 11 May 2021
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Attention Bias Modification for Posttraumatic Stress Disorder: An Entirely Remote Study
- ClinicalTrials.gov ID
- NCT04888169
- Acronym / sponsor ID
- SMART / 19-27541
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Attention bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 872 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Posted 30 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification - Word Stimuli | Experimental | Device: SMART Mobile App - Attention Bias ModificationAttention 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 - Face Stimuli | Active comparator | Device: SMART Mobile App - Attention Bias ModificationAttention 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 - Word Stimuli | Experimental | Device: SMART Mobile App - Attention Control TrainingAttention 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 - Face Stimuli | Active comparator | Device: SMART Mobile App - Attention Control TrainingAttention 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 - Word Stimuli | Placebo comparator | Device: SMART Mobile App - Placebo TrainingPlacebo 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 - Face Stimuli | Placebo comparator | Device: SMART Mobile App - Placebo TrainingPlacebo 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. |
| Control - Questions | Sham comparator | Device: SMART Mobile App - ControlThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART Mobile App - Attention Bias ModificationABM involves placing the probe behind the neutral stimulus on 100% of the trials. | Device | Attention Bias Modification - Face Stimuli, Attention Bias Modification - Word Stimuli |
| SMART Mobile App - Attention Control TrainingACT involves placing the probe behind the neutral stimulus on 50% of trials, and behind the threat stimulus on 50% of trials. | Device | Attention Control Training - Face Stimuli, Attention Control Training - Word Stimuli |
| SMART Mobile App - Placebo TrainingPlacebo training only includes neutral stimuli. | Device | Placebo Attention Training - Face Stimuli, Placebo Attention Training - Word Stimuli |
| SMART Mobile App - ControlParticipants will only answer questions. | Device | Control - Questions |
Primary outcome
Change in PTSD Checklist-5 (PCL) Score (Before/After Training)
Time frame: Baseline, 4 weeks
Reported are the changes in the PTSD Checklist for the DSM-5 (PCL-5) scores between baseline (Day 1) and post-training (Day 28) in each group. The PCL-5 assesses the presence and severity of 20 different symptoms in posttraumatic stress disorder (PTSD). Each of the 20 items is scored on a severity range of 0 ("Not at All") to 4 ("Extremely"), for a final score range of 0 - 80. A score of 33 and above is indicative of clinically significant PTSD symptoms. Higher scores indicate worse PTSD symptom severity. A 10 point change (up or down) is considered a clinically significant change in PTSD symptoms.
Change in PTSD Checklist-5 (PCL) Score (Follow-up)
Time frame: 4 weeks, 8 Weeks
Reported are the changes in the PTSD Checklist for the DSM-5 (PCL-5) scores between post-training (Day 28) and follow-up (Day 56) in each group. The PCL-5 assesses the presence and severity of 20 different symptoms in posttraumatic stress disorder (PTSD). Each of the 20 items is scored on a severity range of 0 ("Not at All") to 4 ("Extremely"), for a final score range of 0 - 80. A score of 33 and above is indicative of clinically significant PTSD symptoms. Higher scores indicate worse PTSD symptom severity. A 10 point change (up or down) is considered a clinically significant change in PTSD symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Woolley, MD, PhD principal investigator
UCSF, SFVAMC
Joaquin Anguera, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Mobile App - Attention Bias Modification in people with Post Traumatic Stress Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Checklist-5 (PCL) Score (Before/After Training) (time frame: Baseline, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.