Effects of Therapeutic Mobile Game on Anxiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Therapeutic Mobile Game on Anxiety

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Device: ABM-01
* Device: Digital Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Participants receive active ABM-01 for the study | Device: ABM-01<br>* Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT)<br>|
| Placebo Comparator: Placebo Control<br>Participants receive a digital control for the study | Device: Digital Control<br>* Placebo control for ABM-01<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Liebowitz Social Anxiety Scale (LSAS) | A 24-item, self-rated scale to assess social anxiety in situations as well as the level of avoidance of those situations. Each question is rated on a 4-point scale, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Greater scores indicate greater symptom severity. | Baseline to Treatment End (30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Liebowitz Social Anxiety Scale (LSAS) | A 24-item, self-rated scale to assess social anxiety in situations as well as the level of avoidance of those situations. Each question is rated on a 4-point scale, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Scores above 55 indicate social phobia. | Bi-weekly time point and at the 6 and 12 month follow-ups | 
| Generalized Anxiety Disorder - 7 (GAD-7) | A 7-item self-report measure to assess symptoms of anxiety. Each question is rated on a 4-point scale, 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day. Scores range from 0-21, where greater scores indicate greater anxiety symptoms. | Bi-weekly time point and at the 6 and 12 month follow-ups | 
| Beck Anxiety Inventory (BAI) | A 21-Item self-report measure to assess symptoms of anxiety. Each question is rated on a 4-point scale, 0 = not at all, 1 = mildly but it didn't bother me much, 2 = moderately - it wasn't pleasant at times, and 3 = severely, it bothered me a lot. Higher scores indicate more severe anxiety symptoms. | Baseline to Treatment End (30 days) | 
| State-Trait Anxiety Scale (STAI) | A 40-Item self-report measure to assess symptoms of state and trait anxiety. There are 20 questions for state anxiety and 20 questions assessing trait anxiety. Each question is rate on a 4-point scale, where 1 = not at all, 2 = somewhat, 3 = moderately so, and 4 = very much so. Greater scores indicate more severe anxiety symptoms. | Baseline to Treatment End (30 days) | 
| Hamilton Anxiety Rating Scale (HAM-A) | A 14-Item self-report measure to assess symptoms of anxiety. Each item is scored on a scale of 0 = not present to 4 = severe, with a total score range of 0-56. Greater scores indicate more severe anxiety symptoms. | Baseline to Treatment End (30 days) | 
| Depression, Anxiety, and Stress Scale (DASS-21) | A 21-Item anxiety, depression, and stress measure. Consisted of anxiety, depression, and stress sub-scales. Each question is rated on a 4-point scale, where 0 = did not apply to me at all, 1 = applied to me to some degree, or some of the time, 2 = applied to me to a considerable degree or a good part of time, and 3 = applied to me very much or most of the time. Greater scores indicate greater symptom severity. Anxiety subscale only. | Baseline to Treatment End (30 days) | 
| Generalized Anxiety Disorder-7 (GAD-7) | A 7-item self-report measure to assess symptoms of anxiety. Each question is rated on a 4-point scale, 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day. Scores range from 0-21, where greater scores indicate greater anxiety symptoms. | Baseline to Treatment End (30 days) |