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Wiring Adolescents With Social Anxiety Via Behavioral Interventions

Wiring Adolescents With Social Anxiety Via Behavioral Interventions (WASABI): a Closed-loop Mobile Intervention to Reduce Social Anxiety and Improve Social Skills

NCT03990870•Posit Science Corporation

View on ClinicalTrials.gov

Summary

This study is a validation study to evaluate the acceptability, feasibility and impact of WASABI (Wiring Adolescents With Social Anxiety via Behavioral Interventions), a mobile application employing a closed-loop technology in adolescents with a Social Anxiety and to prepare for a large-scale efficacy trial in this population. The goal of this study is to evaluate WASABI-a clinician-assisted, adjunct to treatment, mobile application designed to augment the efficacy of psychological Evidence Based Treatments through a closed-loop technology.

Detailed Description

This study will employ an innovative and evidence-based mobile intervention that includes Ecological Momentary Assessments (EMAs) data collected from mobile devices, the WASABI closed-loop algorithm to detect exacerbation of social anxiety, and 1:1 and group-based videoconferencing and Instant Messaging with peers and providers. This study will test WASABI as an adjunct to digital Cognitive Behavioral Group Therapy (dCBGT) in adolescents with Social Anxiety (SA), in a parallel arm, double-blind, randomized, controlled clinical trial to assess feasibility and initial efficacy, to investigate the generalization of trained cognitive skills in the natural environment and improving anxiety and social functioning, and to prepare for a large-scale efficacy trials in adults with adolescents with Social Anxiety.

Eligibility

Age

14 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Potential participant is between the ages of 14 and 18 (inclusive) at the time of consent
•2. Potential participant has a clinical diagnosis of Anxiety Disorder, as confirmed using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID), a brief structured diagnostic interview using Diagnostic and Statistical Manual of Mental Disorders-4 (DSM-IV) criteria
•3. Potential participant has clinically significant Social Anxiety, as defined by a score of 25 or greater on the Social Phobia and Anxiety Inventory
•4. Potential participant is clinically stable at time of screening as determined by the screening clinician/study team and the following criteria:
•* Potential participant has not experienced a psychiatric hospitalization within the 4 weeks prior to screening
•* Potential participant on a medication for anxiety and psychiatric disorders must be on a stable medication regimen for ≥ 4 weeks prior to screening, based on self-report.
•5. Potential participant has a IQ Score \> 80 as determined by performance on the Wechsler Abbreviated Scale of Intelligence (WASI-II)
•6. Potential participant is a fluent English speaker, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician, to ensure reasonable neuropsychological results on key assessments
•7. Potential participant has adequate sensorimotor capacity to perform the intervention and study activities, including visual capacity adequate to read from a computer screen or mobile device at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician and/or study team
•8. Potential participant has reliable access to wireless Internet connectivity
+1 more criteria

Exclusion Criteria

•1. Potential participant has a diagnosis of autism spectrum disorders, history of seizure disorder or seizure episodes within the last 2 years
•2. Potential participant is currently receiving psychotherapy
•3. Potential participant has a history of mental retardation, pervasive developmental disorder, head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
•4. Potential participant has medical illnesses deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, cardiovascular, endocrine, ongoing chemotherapy or other cancer treatment
•5. Potential participant has history or current DSM-5 diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder NOS (not otherwise specified), bipolar disorder, substance dependence (\<1 year), and/or mood congruent or mood incongruent psychotic features or disorders
•6. Potential participants had significant medication changes, including changes to anxiety medications or other psychiatric medications, in the 4 weeks prior to screening
•7. Potential participants who have answered 'yes' to:
•1. Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS), or,
•2. Any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" portion will be excluded from the study if the ideation or behavior occurred within 2 months from Participant's date of consent (as recommended by the FDA for treatment trials.) Participants excluded for this reason will be referred for appropriate treatment. Further, the C-SSRS form will also be administered to all participants at the follow-up visit. Participants meeting these criteria at any time throughout the study will be asked to complete a final assessment, if appropriate, then withdrawn from the study and referred for appropriate treatment.
•8. Potential participant that shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit or dCBGT session. Such participants will have that visit re-scheduled; participants with this problem occurring more than once may be excluded and dropped at the discretion of the PI.
+2 more criteria

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

June 11, 2020

Primary Completion Date

November 4, 2021

Completion Date

November 24, 2021

Last Updated

June 1, 2023

Enrollment

ACTUAL participants

Conditions

Social Anxiety

Interventions

dCBGT + WASABI

OTHER

dCBGT Only

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Wiring Adolescents With Social Anxiety Via Behavioral Interventions

Inclusion Criteria

Exclusion Criteria

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

Individual Factors of CBT Underlying Success

Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder

Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety

Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety