Trial Outcomes & Findings for Wiring Adolescents With Social Anxiety Via Behavioral Interventions (NCT NCT03990870)
NCT ID: NCT03990870
Last Updated: 2023-06-01
Results Overview
Completed Ecological Momentary Assessments (EMAs) at least once per week. EMAs are repeated measures of the participants' current behaviors and experiences in real time.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-06-01
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
COMPLETED
|
13
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wiring Adolescents With Social Anxiety Via Behavioral Interventions
Baseline characteristics by cohort
| Measure |
Experimental Treatment
n=16 Participants
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).
|
Active Comparator
n=8 Participants
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).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
15.56 years
STANDARD_DEVIATION 1.63 • n=99 Participants
|
16.38 years
STANDARD_DEVIATION 1.60 • n=107 Participants
|
15.83 years
STANDARD_DEVIATION 1.63 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Highest Grade Level Completed
|
9.13 grade level
STANDARD_DEVIATION 1.63 • n=99 Participants
|
9.88 grade level
STANDARD_DEVIATION 1.89 • n=107 Participants
|
9.38 grade level
STANDARD_DEVIATION 1.71 • n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).
Completed Ecological Momentary Assessments (EMAs) at least once per week. EMAs are repeated measures of the participants' current behaviors and experiences in real time.
Outcome measures
| Measure |
Experimental Treatment
n=13 Participants
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).
|
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).
|
|---|---|---|
|
Ecological Momentary Assessment (EMA) Adherence
|
53 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: While instant messaging was available to all study participants, no use was reported.
Engagement with dCBGT (digitally delivered Cognitive Behavioral Group Therapy) and IM (Instant Messaging) will be evaluated.
Outcome measures
| Measure |
Experimental Treatment
n=13 Participants
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).
|
Active Comparator
n=7 Participants
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).
|
|---|---|---|
|
Number of Group Sessions Attended
|
11.2 group sessions attended
Standard Error 1.0
|
10.7 group sessions attended
Standard Error 1.3
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).
The completion rate for Ecological Momentary Assessments will be evaluated. EMAs are repeated measures of the participants' current behaviors and experiences in real time.
Outcome measures
| Measure |
Experimental Treatment
n=13 Participants
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).
|
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).
|
|---|---|---|
|
Ecological Momentary Assessments (EMA) Completion Rate
EMA Positive Thoughts
|
12 number of entries
Interval 5.0 to 24.0
|
—
|
|
Ecological Momentary Assessments (EMA) Completion Rate
EMA Negative Thoughts
|
10 number of entries
Interval 5.0 to 18.5
|
—
|
|
Ecological Momentary Assessments (EMA) Completion Rate
EMA Positive Feelings
|
14 number of entries
Interval 4.5 to 24.0
|
—
|
|
Ecological Momentary Assessments (EMA) Completion Rate
EMA Negative Feelings
|
14 number of entries
Interval 4.5 to 24.0
|
—
|
|
Ecological Momentary Assessments (EMA) Completion Rate
EMA Goals
|
13 number of entries
Interval 4.5 to 23.0
|
—
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).
The completion rate for the Social Phobia and Anxiety Inventory - Brief will be evaluated.
Outcome measures
| Measure |
Experimental Treatment
n=13 Participants
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).
|
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).
|
|---|---|---|
|
Percentage of Participants Who Completed the Social Phobia and Anxiety Inventory - Brief
|
69 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 16 weeksThe program completion rate will be evaluated.
Outcome measures
| Measure |
Experimental Treatment
n=16 Participants
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).
|
Active Comparator
n=8 Participants
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).
|
|---|---|---|
|
Total Number of Participants Who Complete the Intervention
|
13 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: At end of 16 weeksPopulation: Data was only collected from the dCBGT+WASABI group (Experimental Treatment group).
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.
Outcome measures
| Measure |
Experimental Treatment
n=13 Participants
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).
|
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).
|
|---|---|---|
|
Post-Study Usability Ratings
Acceptability Rating Score
|
5.1 score on a scale
Standard Deviation 1.1
|
—
|
|
Post-Study Usability Ratings
Usability Rating Score
|
3.3 score on a scale
Standard Deviation 0.6
|
—
|
PRIMARY outcome
Timeframe: 16 weeksThe reported number of adverse events due to program use will be evaluated.
Outcome measures
| Measure |
Experimental Treatment
n=13 Participants
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).
|
Active Comparator
n=7 Participants
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).
|
|---|---|---|
|
Reported Number of Adverse Effects
|
0 adverse effects reported
|
0 adverse effects reported
|
Adverse Events
Experimental Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60