Social Anxiety
Conditions
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.
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.
Interventions
OTHERdCBGT + 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).
OTHERdCBGT 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).
Sponsors
University of Minnesota
National Institute of Mental Health (NIMH)
Posit Science Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ecological Momentary Assessment (EMA) Adherence | 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 | 16 weeks | Engagement with dCBGT (digitally delivered Cognitive Behavioral Group Therapy) and IM (Instant Messaging) will be evaluated. |
| Ecological Momentary Assessments (EMA) Completion Rate | 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 | 16 weeks | The completion rate for the Social Phobia and Anxiety Inventory - Brief will be evaluated. |
| Total Number of Participants Who Complete the Intervention | 16 weeks | The program completion rate will be evaluated. |
| Post-Study Usability Ratings | 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 | 16 weeks | The reported number of adverse events due to program use will be evaluated. |
Countries
United States
Participant flow
Pre-assignment details
A total of 34 participants were consented for this trial. Of those, 9 participants did not meet the inclusion criteria and one participant was no longer interested in participating in the study, prior to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Treatment dCBGT + WASABI
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). | 16 |
| Active Comparator dCBGT Only
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). | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Experimental Treatment | Active Comparator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 6 Participants | 18 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Continuous | 15.56 years STANDARD_DEVIATION 1.63 | 16.38 years STANDARD_DEVIATION 1.6 | 15.83 years STANDARD_DEVIATION 1.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 8 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Highest Grade Level Completed | 9.13 grade level STANDARD_DEVIATION 1.63 | 9.88 grade level STANDARD_DEVIATION 1.89 | 9.38 grade level STANDARD_DEVIATION 1.71 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 7 |
| other Total, other adverse events | 0 / 13 | 0 / 7 |
| serious Total, serious adverse events | 0 / 13 | 0 / 7 |
Outcome results
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.
Time frame: 16 weeks
Population: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Treatment | Ecological Momentary Assessment (EMA) Adherence | 53 percentage of participants |
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.
Time frame: 16 weeks
Population: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Treatment | Ecological Momentary Assessments (EMA) Completion Rate | EMA Positive Thoughts | 12 number of entries |
| Experimental Treatment | Ecological Momentary Assessments (EMA) Completion Rate | EMA Negative Thoughts | 10 number of entries |
| Experimental Treatment | Ecological Momentary Assessments (EMA) Completion Rate | EMA Positive Feelings | 14 number of entries |
| Experimental Treatment | Ecological Momentary Assessments (EMA) Completion Rate | EMA Negative Feelings | 14 number of entries |
| Experimental Treatment | Ecological Momentary Assessments (EMA) Completion Rate | EMA Goals | 13 number of entries |
Primary
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
Population: While instant messaging was available to all study participants, no use was reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Treatment | Number of Group Sessions Attended | 11.2 group sessions attended | Standard Error 1 |
| Active Comparator | Number of Group Sessions Attended | 10.7 group sessions attended | Standard Error 1.3 |
p-value: 0.58t-test, 2 sided
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.
Time frame: 16 weeks
Population: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Treatment | Percentage of Participants Who Completed the Social Phobia and Anxiety Inventory - Brief | 69 percentage of participants |
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.
Time frame: At end of 16 weeks
Population: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Treatment | Post-Study Usability Ratings | Acceptability Rating Score | 5.1 score on a scale | Standard Deviation 1.1 |
| Experimental Treatment | Post-Study Usability Ratings | Usability Rating Score | 3.3 score on a scale | Standard Deviation 0.6 |
Primary
Reported Number of Adverse Effects
The reported number of adverse events due to program use will be evaluated.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental Treatment | Reported Number of Adverse Effects | 0 adverse effects reported |
| Active Comparator | Reported Number of Adverse Effects | 0 adverse effects reported |
p-value: 0.95Chi-squared
Primary
Total Number of Participants Who Complete the Intervention
The program completion rate will be evaluated.
Time frame: 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Treatment | Total Number of Participants Who Complete the Intervention | 13 Participants |
| Active Comparator | Total Number of Participants Who Complete the Intervention | 7 Participants |
p-value: 0.35t-test, 2 sided