Effects of Therapeutic Mobile Game on Anxiety

Social Anxiety Disorder Clinical Trial

Official title:

Effects of Therapeutic Mobile Game on Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240794
• Other study ID #: 2022-0015
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Hunter College of City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Device:
• ABM-01
Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT)
• Digital Control
Placebo control for ABM-01

Locations

Country	Name	City	State
United States	Hunter College of the City University of New York	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hunter College of City University of New York	Arcade Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety Sensitivity Index (ASI-3)	A 18-Item self-report measure to assess symptoms of anxiety. Each question is rated on a 5-point scale, where 0 = very little, 1 = a little, 2 = some, 3 = much, and 4 = very much. Greater scores on the scale indicate more severe anxiety symptoms.	Baseline to Treatment End (30 days)
Other	Positive and Negative Affect Schedule (PANAS)	A 20-Item self-reported assessment of positive (10 items) and negative affect (10 items). Each question is rated on a 5-point scale, where 1 = very slightly or not at all, 2 = a little, 3 = moderately, 4 = quite a bit, and 5 = extremely. Greater scores indicate greater positive or negative affect.	Baseline to Treatment End (30 days)
Other	Beck Depression Inventory II (BDI-II)	A 21-Item self-report measure to assess symptoms of depression. Each question is rated on a 4-point scale, where greater scores indicate greater depressive symptoms.	Baseline to Treatment End (30 days)
Other	Patient Health Questionnaire (PHQ-2)	A 2-Item health questionnaire that measures the frequency of depressed mood and anhedonia. Each question is rated on a 4-point scale, where 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day. Greater scores indicate more severe symptom severity.	Baseline to Treatment End (30 days)
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)