NCT05240794

Effects of Therapeutic Mobile Game on Anxiety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Hunter College of City University of New York · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Participants with Social Anxiety Disorder (SAD) will use a digital therapeutic for 30 days, and will complete assessments measuring a broad range of anxiety and mood-related symptoms, with a focus on SAD symptoms, and metrics of functional impairment during this time. After the treatment period, participants will be followed at 6 month and 12 month after the completion of the study.

Detailed description

This study aims to assess the feasibility and efficacy of the digital therapeutic ABM-01 in adults ages 22-65 with SAD. Participants access ABM-01 on their mobile smart phone and complete treatment over a period of 30 days. Enrolled participants will be randomly assigned to one of two groups (Experimental Group and Placebo Control) and be assessed over five periods of time (Baseline Session, 30-Day Treatment Phase, Post-Treatment Session, 6-Month Follow Up Session, 12-Month Follow Up Session). Participants will complete the 30-Day Treatment Phase as well as the five assessments remotely. During the treatment period, participants complete assessments social anxiety and generalized anxiety symptoms, as well as safety and medication use questionnaires.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DEVICE	ABM-01	Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT)
DEVICE	Digital Control	Placebo control for ABM-01

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2022-02-15
• Last updated: 2023-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study