N/A
N=24
Wiring Adolescents With Social Anxiety Via Behavioral Interventions
Social Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03990870 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Ecological Momentary Assessment (EMA) Adherence — 53 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- dCBGT + WASABI (Other); dCBGT Only (Other)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Posit Science Corporation
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ecological Momentary Assessment (EMA) Adherence |
53 | — |
| PRIMARY Number of Group Sessions Attended |
11.2; 10.7 | 0.58 |
| PRIMARY Ecological Momentary Assessments (EMA) Completion Rate |
12; 10; 14; 14; 13 | — |
| PRIMARY Percentage of Participants Who Completed the Social Phobia and Anxiety Inventory - Brief |
69 | — |
| PRIMARY Total Number of Participants Who Complete the Intervention |
13; 7 | 0.35 |
| PRIMARY Post-Study Usability Ratings |
5.1; 3.3 | — |
| PRIMARY Reported Number of Adverse Effects |
0; 0 | 0.95 |
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.
Eligibility Criteria
Inclusion Criteria
- Potential participant is between the ages of 14 and 18 (inclusive) at the time of consent
- 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
- Potential participant has clinically significant Social Anxiety, as defined by a score of 25 or greater on the Social Phobia and Anxiety Inventory
- 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.
- Potential participant has a IQ Score > 80 as determined by performance on the Wechsler Abbreviated Scale of Intelligence (WASI-II)
- 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
- 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
- Potential participant has reliable access to wireless Internet connectivity
- Potential participant can use iOS mobile applications
Exclusion Criteria
- Potential participant has a diagnosis of autism spectrum disorders, history of seizure disorder or seizure episodes within the last 2 years
- Potential participant is currently receiving psychotherapy
- Potential participant has a history of mental retardation, pervasive developmental disorder, head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
- 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
- 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
- Potential participants had significant medication changes, including changes to anxiety medications or other psychiatric medications, in the 4 weeks prior to screening
- Potential participants who have answered 'yes' to:
- Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS), or,
- 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 assessm
Data sourced from ClinicalTrials.gov (NCT03990870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.