Effects of Therapeutic Mobile Game on Anxiety

NCT ID: NCT05240794

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-05-31

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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Participants receive active ABM-01 for the study

Group Type: EXPERIMENTAL

ABM-01

Intervention Type: DEVICE

Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT)

Placebo Control

Participants receive a digital control for the study

Group Type: PLACEBO_COMPARATOR

Digital Control

Intervention Type: DEVICE

Placebo control for ABM-01

Interventions

ABM-01

Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT)

Intervention Type: DEVICE

Digital Control

Placebo control for ABM-01

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcade Therapeutics Inc.

UNKNOWN

Sponsor Role: collaborator

Hunter College of City University of New York

OTHER

Sponsor Role: lead

Responsible Party

Tracy Dennis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracy A Dennis-Tiwary, PhD

Role: PRINCIPAL_INVESTIGATOR

City University of New York, School of Public Health

Locations

Hunter College of the City University of New York

New York, New York, United States

Countries

United States

Other Identifiers

2022-0015

Identifier Type: -

Identifier Source: org_study_id