Wiring Adolescents With Social Anxiety Via Behavioral Interventions

NCT03990870 | Completed Results

• 2 other identifiers: PSC-1016-191R43MH121209-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• 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

• Number of Group Sessions Attended

  Engagement with dCBGT (digitally delivered Cognitive Behavioral Group Therapy) and IM (Instant Messaging) will be evaluated.

  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.

  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.

  16 weeks

• Total Number of Participants Who Complete the Intervention

  The program completion rate will be evaluated.

  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.

  At end of 16 weeks

• Reported Number of Adverse Effects

  The reported number of adverse events due to program use will be evaluated.

  16 weeks

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

dCBGT + WASABI

Other: dCBGT + WASABI

Active Comparator

ACTIVE COMPARATOR

dCBGT Only

Other: dCBGT Only

Interventions

dCBGT + WASABI OTHER

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).

Experimental Treatment

dCBGT Only OTHER

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).

Active Comparator

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 assessment, if appropriate, then withdrawn from the study and referred for appropriate treatment.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Posit Science Corporation: lead
• University of Minnesota: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Limitations and Caveats

Lack of diversity in study population, 4 participants from ethnic groups withdrew prior to randomization. We did not record information on the time spent by the WASABI clinician in monitoring engagement, progress, and in providing feedback beyond the weekly group sessions. Since the WASABI group filled out 16 SPAI items many more times than the control group, this can could potentially limit the scientific rigor of the results. Using only one clinician as the therapist for all participants.

Results Point of Contact

• Title: Dr. Kyu Lee
• Organization: Posit Science Corporation

kyu.lee@positscience.com

415-528-7235

Study Officials

• Bruno Biagianti, MD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: June 11, 2020
• Primary Completion: November 4, 2021
• Study Completion: November 24, 2021
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Locations

US (1)