ABM-01 for Social Anxiety Disorder

TA
NG
Overseen ByNayan Ghosh
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hunter College of City University of New York

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.12345

Why 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?

TA

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

Adults 22-65 at the time of screening
You have been diagnosed with Social Anxiety Disorder according to the DSM-5 guidelines.
Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration
See 1 more

Exclusion Criteria

You have a high risk of attempting suicide or have tried to commit suicide within the past two years.
Currently pregnant or planning to become pregnant during the treatment period
You have a serious problem with using drugs or alcohol.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Session

Participants complete baseline assessments before starting treatment

1 day
1 visit (virtual)

30-Day Treatment Phase

Participants use the digital therapeutic ABM-01 and complete assessments remotely

4 weeks
Remote assessments

Post-Treatment Session

Participants complete assessments after the treatment phase

1 day
1 visit (virtual)

6-Month Follow-Up Session

Participants are monitored for safety and effectiveness 6 months after treatment

1 day
1 visit (virtual)

12-Month Follow-Up Session

Participants are monitored for safety and effectiveness 12 months after treatment

1 day
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • ABM-01
  • Digital Control
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental groupExperimental Treatment1 Intervention
Group II: Placebo ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hunter College of City University of New York

Lead Sponsor

Trials
43
Recruited
10,000+

Wise Therapeutics Inc.

Collaborator

Trials
1
Recruited
150+

Arcade Therapeutics Inc.

Collaborator

Trials
1
Recruited
150+

Citations

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