Effects of Therapeutic Mobile Game on Anxiety

• ClinicalTrials.gov Identifier: NCT05240794
• Recruitment Status: Active, not recruiting
• First Posted: February 15, 2022
• Last Update Posted: February 17, 2023
• Sponsor: Hunter College of City University of New York
• Collaborator: Arcade Therapeutics Inc.
• Information provided by (Responsible Party): Tracy Dennis, Hunter College of City University of New York

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Social Anxiety Disorder	Device: ABM-01; Device: Digital Control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Therapeutic Mobile Game on Anxiety
• Actual Study Start Date: June 15, 2022
• Estimated Primary Completion Date: June 15, 2023
• Estimated Study Completion Date: June 15, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental group; Participants receive active ABM-01 for the study	Device: ABM-01; Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT)
Placebo Comparator: Placebo Control; Participants receive a digital control for the study	Device: Digital Control; Placebo control for ABM-01

Outcome Measures

Primary Outcome Measures :

1. The Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.

Secondary Outcome Measures :

1. The Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Bi-weekly time point and at the 6 and 12 month follow-ups ]
   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.
2. Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Bi-weekly time point and at the 6 and 12 month follow-ups ]
   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.
3. Beck Anxiety Inventory (BAI) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.
4. State-Trait Anxiety Scale (STAI) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.
5. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.
6. Depression, Anxiety, and Stress Scale (DASS-21) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.
7. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.

Other Outcome Measures:

1. Anxiety Sensitivity Index (ASI-3) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.
2. Positive and Negative Affect Schedule (PANAS) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.
3. Beck Depression Inventory II (BDI-II) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.
4. Patient Health Questionnaire (PHQ-2) [ Time Frame: Baseline to Treatment End (30 days) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Hunter College of the City University of New York

New York, New York, United States, 10065

Sponsors and Collaborators

Hunter College of City University of New York

Arcade Therapeutics Inc.

Investigators

• Principal Investigator: Tracy A Dennis-Tiwary, PhD; City University of New York, School of Public Health

More Information

• Responsible Party: Tracy Dennis, Professor, Hunter College of City University of New York
• ClinicalTrials.gov Identifier: NCT05240794
• Other Study ID Numbers: 2022-0015
• First Posted: February 15, 2022
• Last Update Posted: February 17, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Anxiety Disorders; Phobia, Social; Mental Disorders; Phobic Disorders