ABM-01 for Social Anxiety Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a mobile game called ABM-01 to determine if it can reduce symptoms of Social Anxiety Disorder (SAD). Participants will use the game for 30 days, with their anxiety and mood symptoms tracked during and after treatment. The trial includes two groups: one using the real game and the other using a placebo (a non-active version). Ideal participants are those living in the United States who have been diagnosed with SAD and are willing to use a smartphone or computer for the study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new ways to manage Social Anxiety Disorder.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research on ABM-01, the treatment used in this trial, has not yet provided specific safety information for humans. The trial is marked as "Not Applicable" for phase, indicating it might not have undergone the usual early safety tests in humans. However, digital treatments like ABM-01 typically do not carry the same risks as traditional drugs, such as side effects or allergies.
As a therapeutic mobile game, ABM-01 is likely safer than medications, as mobile games generally do not cause physical side effects. This treatment aims to help people with social anxiety through digital methods. Prospective participants should discuss any concerns with the study team or a healthcare provider before joining the trial.12345Why are researchers excited about this trial?
Researchers are excited about ABM-01 because it offers a fresh approach to managing anxiety through a therapeutic mobile game. Unlike traditional treatments, such as medication and therapy, ABM-01 provides a digital, non-invasive option that can be easily accessed via smartphones. This method leverages the engaging nature of gaming, which might enhance user adherence and make it easier for individuals to integrate into their daily routines. Additionally, the use of a mobile platform could potentially allow for real-time data tracking and personalized adjustments, offering a tailored experience for each user.
What evidence suggests that this trial's treatments could be effective for Social Anxiety Disorder?
Research has shown that digital treatments like ABM-01, which participants in this trial may receive, can help manage anxiety by engaging users in activities that reduce stress and boost mood. Although specific data on ABM-01 for Social Anxiety Disorder (SAD) is limited, similar digital tools have shown promise in early studies for reducing anxiety. These tools often include exercises that help users focus less on anxious thoughts. Early results from related digital therapies suggest they can improve anxiety symptoms and daily functioning. This suggests that ABM-01 might effectively manage SAD symptoms. Participants in the placebo control arm will receive a digital control for comparison.678910
Who Is on the Research Team?
Tracy A Dennis-Tiwary, PhD
Principal Investigator
City University of New York, School of Public Health
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Session
Participants complete baseline assessments before starting treatment
30-Day Treatment Phase
Participants use the digital therapeutic ABM-01 and complete assessments remotely
Post-Treatment Session
Participants complete assessments after the treatment phase
6-Month Follow-Up Session
Participants are monitored for safety and effectiveness 6 months after treatment
12-Month Follow-Up Session
Participants are monitored for safety and effectiveness 12 months after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABM-01
- Digital Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hunter College of City University of New York
Lead Sponsor
Wise Therapeutics Inc.
Collaborator
Arcade Therapeutics Inc.
Collaborator