Skip to main content
OpenTrials
Completed

NCT Number: NCT05240794

Effects of Therapeutic Mobile Game on Anxiety

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter College of the City University of New York

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABM-01

Device

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

Digital Control

Device

Placebo control for ABM-01

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • Arcade Therapeutics

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.