Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT05240794
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2022-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Therapeutic Mobile Game on Anxiety
Sponsor:
Hunter College of City University of New York
Organization:
Study Overview
Official Title:
Effects of Therapeutic Mobile Game on Anxiety
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: