Clinical trial NCT05240794: Effects of Therapeutic Mobile Game on Anxiety
Official title: Effects of Therapeutic Mobile Game on Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: Arcade Therapeutics Inc.
First posted: 2022-02-15
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Baseline to Treatment End (30 days)
Secondary outcomes:
measure: The Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Bi-weekly time point and at the 6 and 12 month follow-ups
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Bi-weekly time point and at the 6 and 12 month follow-ups
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline to Treatment End (30 days)
measure: State-Trait Anxiety Scale (STAI)
timeFrame: Baseline to Treatment End (30 days)
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Baseline to Treatment End (30 days)
measure: Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Baseline to Treatment End (30 days)
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline to Treatment End (30 days)
Other outcomes:
measure: Anxiety Sensitivity Index (ASI-3)
timeFrame: Baseline to Treatment End (30 days)
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline to Treatment End (30 days)
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Baseline to Treatment End (30 days)
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: Baseline to Treatment End (30 days)
Locations:
city: New York
country: United States
facility: Hunter College of the City University of New York
state: New York
Study officials:
affiliation: City University of New York, School of Public Health
name: Tracy A Dennis-Tiwary, PhD
role: PRINCIPAL_INVESTIGATOR
References: