Attention Bias Modification for PTSD

(SMART Trial)

Not currently recruiting at 2 trial locations

Overseen By Joshua Woolley, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: No smartphone, Active suicidality

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if attention bias modification (ABM) can assist individuals with significant PTSD symptoms by training them to divert focus from threatening information. Participants will engage in various attention training tasks, involving words or faces, to identify the most effective method for reducing stress, anxiety, and depression symptoms. Suitable candidates should have PTSD symptoms that disrupt daily life and be willing to use a smartphone for training.

As an unphased trial, this study provides participants the chance to contribute to innovative research that may lead to new PTSD treatments.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Attention Bias Modification (ABM) and Attention Control Training (ACT) are generally safe for individuals. These treatments can improve symptoms of PTSD, depression, and anxiety. Reports of harmful side effects from these treatments are rare.

One study found both ABM and a control treatment similarly effective in reducing PTSD symptoms, with no significant negative effects, suggesting that the treatments are well-tolerated. Since these treatments involve screen-based tasks rather than medication, they typically have fewer physical side effects.

Joining a trial is a personal decision. It is important to consider all the information and consult healthcare professionals if needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Attention Bias Modification (ABM) for PTSD because it offers a novel approach by targeting attention patterns directly. Unlike traditional therapies such as cognitive behavioral therapy or medications like SSRIs that often take weeks to show effects, ABM works by retraining the brain to focus less on threatening stimuli. This is done through a simple, game-like task on a screen, making it both non-invasive and accessible. By potentially reducing PTSD symptoms faster and more efficiently, ABM could be a game-changer in the way we treat this condition.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Attention Bias Modification (ABM), a treatment in this trial, can help reduce symptoms of PTSD (Post-Traumatic Stress Disorder). Studies indicate that both ABM and attention control training (ACT), another treatment option in this trial, effectively improve PTSD symptoms. For instance, one study found that ABM reduced the tendency to focus on threats, which is linked to the severity of PTSD and anxiety. Both ABM and ACT also improved related symptoms like depression and anxiety. These findings suggest that training the mind to focus less on negative thoughts might help ease PTSD symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Joshua Woolley, MD, PhD

Principal Investigator

UCSF, SFVAMC

Joaquin Anguera, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 55 who have significant post-traumatic stress symptoms, as indicated by a score of at least 33 on the PCL-5. Participants must own a smartphone compatible with the study's app and be willing to engage in daily training for two weeks. Those without the required smartphone or current suicidal thoughts cannot participate.

Inclusion Criteria

Able and willing to perform daily smartphone training for two weeks

You have an Android or iPhone smartphone.

You have a score of 33 or higher on a posttraumatic stress disorder (PTSD) checklist.

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

You are currently having thoughts or plans of hurting yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

24 months

Treatment

Participants undergo 14 sessions of attention bias modification (ABM), attention control training (ACT), placebo neutral attention training, or a control condition with daily questions

4 weeks

Follow-up

Participants are monitored for changes in PTSD symptoms and other psychological factors

4 weeks

Long-term Follow-up

Participants are assessed for sustained changes in PTSD symptoms at 8 weeks

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Bias Modification
• Attention Control Training
• Placebo Training

Trial Overview The study tests four different smartphone-based trainings: attention bias modification, attention control training, placebo neutral attention training, and a control condition involving daily questions. The goal is to see how these affect attention bias and self-reported stress symptoms over eight weeks in nearly 1,900 participants.

How Is the Trial Designed?

Group I: Attention Control Training - Word Stimuli Experimental Treatment 1 Intervention

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%.

Group II: Attention Bias Modification - Word Stimuli Experimental Treatment 1 Intervention

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.

Group III: Attention Bias Modification - Face Stimuli Active Control 1 Intervention

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.

Group IV: Attention Control Training - Face Stimuli Active Control 1 Intervention

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%.

Group V: Control - Questions Placebo Group 1 Intervention

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.

Group VI: Placebo Attention Training - Face Stimuli Placebo Group 1 Intervention

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.

Group VII: Placebo Attention Training - Word Stimuli Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

San Francisco Veterans Affairs Medical Center

Collaborator

Trials

52

Recruited

211,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11022678/

Attentional bias modification and attention control training in ... Attentional bias modification (ABM) and attention control training (ACT) have demonstrated the effect of improving PTSD, but the results of randomized ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23295710/

Attentional bias modification in posttraumatic stress disorder Results: ABM and the control treatment were equally effective in reducing the symptoms of PTSD. The effect sizes of the improvement (from before to after ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01368302

Attention Bias Modification Treatment (ABMT) for Patients ... Outcome measures will be Post Traumatic Stress Disorder (PTSD), depression, and anxiety symptoms as measured by gold standard questionnaires and symptom counts ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/2024/3683656

Measuring and Modifying Threat‐Related Attention Bias in ... Results: RB-AB is a reliable strategy for deriving threat-related attention bias scores that correlate with both PTSD severity and anxiety. On ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20451253241243260

Attentional bias modification and attention control training ... Attentional bias modification (ABM) and attention control training (ACT) have demonstrated the effect of improving PTSD, but the results of randomized ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4258474/

The Effectiveness of an Attention Bias Modification Program ... As individuals with PTSD possess an attentional bias towards threat-relevant information ABM may prove effective in reducing PTSD symptoms.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301051116300047

Acute delivery of attention bias modification training (ABMT ... Regression analysis revealed that combat exposure uniquely accounted for 4.6% of the variance in stress-related symptoms change from baseline to follow-up and ...

8. karger.com karger.com/pps/article/82/2/99/282675/Attentional-Bias-Modification-in-Posttraumatic

Attentional Bias Modification in Posttraumatic Stress Disorder Results: ABM and the control treatment were equally effective in reducing the symptoms of PTSD. The effect sizes of the improvement (from before ...