Effects of Therapeutic Mobile Game on Anxiety

Hunter College of City University of New York

Status: Completed

Conditions: Social Anxiety Disorder

Treatments: Device: Digital Control; Device: ABM-01

Study type: Interventional

Funder types: Other

Identifiers

NCT05240794

2022-0015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 22-65 at the time of screening
• Meets DSM-5 diagnostic criteria for Social Anxiety Disorder
• Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration.
• Currently residing in the United States

Exclusion criteria

• Risk of suicide or has attempted suicide within 24 months of the screening visit
• Moderate to severe substance use disorder
• Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, Autism Spectrum Disorder, or Borderline Personality Disorder
• Currently pregnant or planning to become pregnant during the treatment period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Participants receive active ABM-01 for the study

Treatment:

Device: ABM-01

Placebo Control

Placebo Comparator group

Description:

Participants receive a digital control for the study

Treatment:

Device: Digital Control