NCT05240794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

January 24, 2022

Last Update Submit

October 3, 2023

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • The Liebowitz Social Anxiety Scale (LSAS)

    Bi-weekly time point and at the 6 and 12 month follow-ups

  • Generalized Anxiety Disorder - 7 (GAD-7)

    Bi-weekly time point and at the 6 and 12 month follow-ups

  • Beck Anxiety Inventory (BAI)

    Baseline to Treatment End (30 days)

  • State-Trait Anxiety Scale (STAI)

    Baseline to Treatment End (30 days)

  • Hamilton Anxiety Rating Scale (HAM-A)

    Baseline to Treatment End (30 days)

  • +2 more secondary outcomes

Other Outcomes (4)

  • Anxiety Sensitivity Index (ASI-3)

    Baseline to Treatment End (30 days)

  • Positive and Negative Affect Schedule (PANAS)

    Baseline to Treatment End (30 days)

  • Beck Depression Inventory II (BDI-II)

    Baseline to Treatment End (30 days)

  • +1 more other outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants receive active ABM-01 for the study

Device: ABM-01

Placebo Control

PLACEBO COMPARATOR

Participants receive a digital control for the study

Device: Digital Control

Interventions

ABM-01DEVICE

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

Experimental group
Digital ControlDEVICE

Placebo control for ABM-01

Placebo Control

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter College of the City University of New York

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Tracy A Dennis-Tiwary, PhD

    City University of New York, School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 15, 2022

Study Start

June 15, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)