Social Anxiety DisorderNCT05240794
Effects of Therapeutic Mobile Game on Anxiety
A study testing ABM-01 in people with Social Anxiety Disorder, run by Hunter College of City University of New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- ABM-01
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter College of the City University of New York
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- ABM-01, Digital Control
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABM-01Device
Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT)
Digital ControlDevice
Placebo control for ABM-01
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants receive active ABM-01 for the study Receives: Device: ABM-01 |
| Placebo Control | Placebo comparator | Participants receive a digital control for the study Receives: Device: Digital Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Treatment End (30 days)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Treatment End (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 Jun 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Arcade Therapeutics
- Responsible party
- Principal investigator, Tracy Dennis, Hunter College of City University of New York
- Investigators
- Tracy A Dennis-Tiwary, PhD, Principal investigator, City University of New York, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240794
- Sponsor's protocol ID
- 2022-0015
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Mobile Game on Anxiety
- ClinicalTrials.gov ID
- NCT05240794
- Acronym / sponsor ID
- 2022-0015
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- Arcade Therapeutics
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: ABM-01Participants receive active ABM-01 for the study |
| Placebo Control | Placebo comparator | Device: Digital ControlParticipants receive a digital control for the study |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABM-01Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT) | Device | Experimental group |
| Digital ControlPlacebo control for ABM-01 | Device | Placebo Control |
Primary outcome
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.
7 secondary outcomes
The Liebowitz Social Anxiety Scale (LSAS)
Time frame: Bi-weekly time point and at the 6 and 12 month follow-ups
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Bi-weekly time point and at the 6 and 12 month follow-ups
Beck Anxiety Inventory (BAI)
Time frame: Baseline to Treatment End (30 days)
State-Trait Anxiety Scale (STAI)
Time frame: Baseline to Treatment End (30 days)
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Baseline to Treatment End (30 days)
Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: Baseline to Treatment End (30 days)
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline to Treatment End (30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy A Dennis-Tiwary, PhD principal investigator
City University of New York, School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABM-01 in people with Social Anxiety Disorder, run by Hunter College of City University of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Liebowitz Social Anxiety Scale (LSAS) (time frame: Baseline to Treatment End (30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.