Wiring Adolescents With Social Anxiety Via Behavioral Interventions

Social Anxiety Clinical Trial

— WASABI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990870
• Other study ID #: PSC-1016-19
• Secondary ID: 1R43MH121209-01
• Status: Completed
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: November 24, 2021

Study information

• Verified date: May 2023
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 24, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

9. Potential participant can use iOS mobile applications

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.

9. Potential participant has problems performing assessments or comprehending or following spoken instructions, or participant displays behaviors during assessments visits or dCBGT sessions that, in the judgment of the clinician and study team, are likely to present significant problems for the Site Study personnel or other participants.

10. Potential participant is enrolled in a concurrent clinical trial involving an investigational pharmaceutical, medical device, behavioral treatment, or any other clinical trial that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications is allowable.

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Posit Science Corporation	National Institute of Mental Health (NIMH), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Primary	Number of Group Sessions Attended	Engagement with dCBGT (digitally delivered Cognitive Behavioral Group Therapy) and IM (Instant Messaging) will be evaluated.	16 weeks
Primary	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.	16 weeks
Primary	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.	16 weeks
Primary	Total Number of Participants Who Complete the Intervention	The program completion rate will be evaluated.	16 weeks
Primary	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.	At end of 16 weeks
Primary	Reported Number of Adverse Effects	The reported number of adverse events due to program use will be evaluated.	16 weeks