NCT03990870

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Posit Science Corporation · Industry
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Social Anxiety

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-06-11
• Primary completion: 2021-11-04
• Completion: 2021-11-24
• First posted: 2019-06-19
• Last updated: 2023-06-01
• Results posted: 2023-06-01

Locations

1 site across 1 country: United States