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Wiring Adolescents With Social Anxiety Via Behavioral Interventions

NCT03990870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-06-01

Study results available
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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.

Conditions

  • Social Anxiety

Interventions

OTHER

dCBGT + WASABI

Participants in the experimental treatment group will complete daily Ecological Momentary Assessments (EMAs), 1 hour of digitally delivered Cognitive Behavioral Group Therapy (dCBGT) per week, and weekly cognitive biases assessments and self-reports for 16 weeks. Participants assigned to this intervention will also have daily access to 1:1 and group chat Instant Messaging (IM) and will have weekly electronic check-ins with study staff (as needed).

OTHER

dCBGT Only

Participants in the active comparator group will be asked to attend 1 hour of digitally delivered Cognitive Behavioral Group Therapy (dCBGT) per week for 16 weeks and weekly electronic check-ins with study staff (as needed).

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Posit Science Corporation

    lead INDUSTRY

Principal Investigators

  • Bruno Biagianti, MD · Posit Science Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-11
Primary Completion
2021-11-04
Completion
2021-11-24

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990870 on ClinicalTrials.gov