Social AnxietyWASABINCT03990870

Wiring Adolescents With Social Anxiety Via Behavioral Interventions

A study testing dCBGT + WASABI and dCBGT Only in people with Social Anxiety, run by Posit Science Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 14 to 18 years
Conditions the study is for: Social Anxiety
What is being tested?: dCBGT + WASABI and dCBGT Only
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 11 Jun 2020to 24 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

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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

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55454

Other trials in United States

About this study

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

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.

Read the 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
Being tested: dCBGT + WASABI, dCBGT Only

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dCBGT + WASABIOther
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 OnlyOther
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).

Study groups in NCT03990870
Study group	Role	What they receive
Experimental Treatment	Experimental	dCBGT + WASABI Receives: Other: dCBGT + WASABI
Active Comparator	Active comparator	dCBGT Only Receives: Other: dCBGT Only

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 202024 Nov 2021

First posted19 Jun 2019
Study start11 Jun 2020
Primary completion4 Nov 2021
Study completion24 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Social AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03990870
Sponsor's protocol ID: PSC-1016-19
Other IDs: 1R43MH121209-01
Acronym: WASABI
Status last verified: May 2023
First submitted: 17 Jun 2019
Last updated: 1 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Wiring Adolescents With Social Anxiety Via Behavioral Interventions (WASABI): a Closed-loop Mobile Intervention to Reduce Social Anxiety and Improve Social Skills
ClinicalTrials.gov ID: NCT03990870
Acronym / sponsor ID: WASABI / PSC-1016-19
Conditions: Social Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Posit Science CorporationIndustry (pharma, biotech, devices)
Collaborators: University of Minnesota, National Institute of Mental Health (NIMH)
Study start: 11 Jun 2020 (actual)
Primary completion: 4 Nov 2021 (actual)
Study completion: 24 Nov 2021 (actual)
First posted: 19 Jun 2019 (actual)
Results: Posted 1 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental Treatment	Experimental	Other: dCBGT + WASABIdCBGT + WASABI
Active Comparator	Active comparator	Other: dCBGT OnlydCBGT Only

Who may qualify

Ages: 14 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

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 a IQ Score > 80 as determined by performance on the Wechsler Abbreviated Scale of Intelligence (WASI-II)

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dCBGT + WASABIParticipants 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	Experimental Treatment
dCBGT OnlyParticipants 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).	Other	Active Comparator

Primary outcome

Ecological Momentary Assessment (EMA) Adherence
Time frame: 16 weeks
Completed Ecological Momentary Assessments (EMAs) at least once per week. EMAs are repeated measures of the participants' current behaviors and experiences in real time.
Number of Group Sessions Attended
Time frame: 16 weeks
Engagement with dCBGT (digitally delivered Cognitive Behavioral Group Therapy) and IM (Instant Messaging) will be evaluated.
Ecological Momentary Assessments (EMA) Completion Rate
Time frame: 16 weeks
The completion rate for Ecological Momentary Assessments will be evaluated. EMAs are repeated measures of the participants' current behaviors and experiences in real time.
Percentage of Participants Who Completed the Social Phobia and Anxiety Inventory - Brief
Time frame: 16 weeks
The completion rate for the Social Phobia and Anxiety Inventory - Brief will be evaluated.
Total Number of Participants Who Complete the Intervention
Time frame: 16 weeks
The program completion rate will be evaluated.
Post-Study Usability Ratings
Time frame: At end of 16 weeks
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.
Reported Number of Adverse Effects
Time frame: 16 weeks
The reported number of adverse events due to program use will be evaluated.

Results and safety

Results posted to the registry on 1 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Treatment	16	13
Active Comparator	8	7

Primary outcome: Ecological Momentary Assessment (EMA) Adherence

Time frame: 16 weeks. Number. Unit: percentage of participants

Measure	Experimental Treatment n = 13
Value	53

Population analysed: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).

Primary outcome: Number of Group Sessions Attended

Time frame: 16 weeks. Mean (Standard Error). Unit: group sessions attended

Measure	Experimental Treatment n = 13	Active Comparator n = 7
Value	11.2 (1.0)	10.7 (1.3)

Experimental Treatment vs Active Comparator: p = 0.58, t-test, 2 sided

Population analysed: While instant messaging was available to all study participants, no use was reported.

Primary outcome: Ecological Momentary Assessments (EMA) Completion Rate

Time frame: 16 weeks. Median (Inter-Quartile Range). Unit: number of entries

Measure	Experimental Treatment n = 13
EMA Positive Thoughts	12 (5 to 24)
EMA Negative Thoughts	10 (5 to 18.5)
EMA Positive Feelings	14 (4.5 to 24)
EMA Negative Feelings	14 (4.5 to 24)
EMA Goals	13 (4.5 to 23)

Population analysed: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).

Primary outcome: Percentage of Participants Who Completed the Social Phobia and Anxiety Inventory - Brief

Time frame: 16 weeks. Number. Unit: percentage of participants

Measure	Experimental Treatment n = 13
Value	69

Population analysed: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).

Adverse events

Time frame: Adverse event data are collected throughout the study duration. Study participation is 16 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Treatment	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Active Comparator	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruno Biagianti, MD principal investigator

Posit Science Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing dCBGT + WASABI and dCBGT Only in people with Social Anxiety, run by Posit Science Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ecological Momentary Assessment (EMA) Adherence (time frame: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03990870.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.