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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
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).
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).
University of Minnesota
Minneapolis, Minnesota, United States
Ecological Momentary Assessment (EMA) Adherence
Completed Ecological Momentary Assessments (EMAs) at least once per week. EMAs are repeated measures of the participants' current behaviors and experiences in real time.
Time frame: 16 weeks
Number of Group Sessions Attended
Engagement with dCBGT (digitally delivered Cognitive Behavioral Group Therapy) and IM (Instant Messaging) will be evaluated.
Time frame: 16 weeks
Ecological Momentary Assessments (EMA) Completion Rate
The completion rate for Ecological Momentary Assessments will be evaluated. EMAs are repeated measures of the participants' current behaviors and experiences in real time.
Time frame: 16 weeks
Percentage of Participants Who Completed the Social Phobia and Anxiety Inventory - Brief
The completion rate for the Social Phobia and Anxiety Inventory - Brief will be evaluated.
Time frame: 16 weeks
Total Number of Participants Who Complete the Intervention
The program completion rate will be evaluated.
Time frame: 16 weeks
Post-Study Usability Ratings
An exit poll with 25 items was used to evaluate acceptability and usefulness ratings of the intervention: Sixteen items assessed Acceptability Rating of the WASABI app with a Likert scale from (1) Completely Disagree to (7) Completely Agree. The Acceptability Rating score is out of 7, higher number is better. The reported Acceptability Rating score is an average of all scores. Nine items explored the Usefulness of content delivered during the group tele-therapy sessions and through cognitive assessments and EMAs with a Likert scale from (1) Not at all to (4) Extremely). The Usability Rating score is out of 4, higher number is better. The reported Usefulness Rating score is an average of all scores.
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Time frame: At end of 16 weeks
Reported Number of Adverse Effects
The reported number of adverse events due to program use will be evaluated.
Time frame: 16 weeks