Trial Outcomes & Findings for A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19 (NCT NCT04524598)
NCT ID: NCT04524598
Last Updated: 2023-05-18
Results Overview
Descriptive report of participant eligibility. Percentage of people who enrolled in each arm after expressing interest in participating in the study. Phase I participant arms are reported for this outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
227 participants
Primary outcome timeframe
Pre-enrollment
Results posted on
2023-05-18
Participant Flow
Participant milestones
| Measure |
Limbix Spark - Phase I
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase I
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Control Extension - Phase II
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|---|
|
Phase I - Feasibility
STARTED
|
35
|
25
|
0
|
0
|
0
|
|
Phase I - Feasibility
COMPLETED
|
31
|
20
|
0
|
0
|
0
|
|
Phase I - Feasibility
NOT COMPLETED
|
4
|
5
|
0
|
0
|
0
|
|
Phase II - Outcomes
STARTED
|
0
|
0
|
80
|
80
|
0
|
|
Phase II - Outcomes
Met PHQ-8 Threshold (Baseline >/= 10)
|
0
|
0
|
63
|
58
|
0
|
|
Phase II - Outcomes
COMPLETED
|
0
|
0
|
54
|
67
|
0
|
|
Phase II - Outcomes
NOT COMPLETED
|
0
|
0
|
26
|
13
|
0
|
|
Phase II - Control Extension
STARTED
|
0
|
0
|
0
|
0
|
66
|
|
Phase II - Control Extension
COMPLETED
|
0
|
0
|
0
|
0
|
54
|
|
Phase II - Control Extension
NOT COMPLETED
|
0
|
0
|
0
|
0
|
12
|
Reasons for withdrawal
| Measure |
Limbix Spark - Phase I
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase I
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Control Extension - Phase II
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|---|
|
Phase I - Feasibility
Lost to Follow-up
|
2
|
4
|
0
|
0
|
0
|
|
Phase I - Feasibility
Dropped for missing two consecutive weekly safety check-ins.
|
2
|
1
|
0
|
0
|
0
|
|
Phase II - Outcomes
Lost to Follow-up
|
0
|
0
|
16
|
8
|
0
|
|
Phase II - Outcomes
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
0
|
|
Phase II - Outcomes
Dropped for missing two consecutive weekly safety check-ins.
|
0
|
0
|
8
|
5
|
0
|
|
Phase II - Control Extension
Lost to Follow-up
|
0
|
0
|
0
|
0
|
6
|
|
Phase II - Control Extension
Dropped for missing two consecutive weekly safety check-ins.
|
0
|
0
|
0
|
0
|
6
|
Baseline Characteristics
A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19
Baseline characteristics by cohort
| Measure |
Limbix Spark - Phase I
n=35 Participants
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase I
n=25 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
n=63 Participants
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
n=58 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
18 years
STANDARD_DEVIATION 2.36 • n=5 Participants
|
17 years
STANDARD_DEVIATION 2.57 • n=7 Participants
|
17.06 years
STANDARD_DEVIATION 2.49 • n=5 Participants
|
16.46 years
STANDARD_DEVIATION 2.43 • n=4 Participants
|
16.78 years
STANDARD_DEVIATION 2.47 • n=21 Participants
|
|
Sex/Gender, Customized
Participant Reported Gender · Female
|
28 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Participant Reported Gender · Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Participant Reported Gender · Non-Binary
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
25 participants
n=7 Participants
|
63 participants
n=5 Participants
|
58 participants
n=4 Participants
|
121 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-enrollmentPopulation: People who expressed interest in participating in the study.
Descriptive report of participant eligibility. Percentage of people who enrolled in each arm after expressing interest in participating in the study. Phase I participant arms are reported for this outcome.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=150 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Phase I - Feasibility (Eligibility)
Limbix Spark - Phase I
|
35 Participants
|
—
|
—
|
—
|
|
Phase I - Feasibility (Eligibility)
Psychoeducation - Phase I
|
25 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline to Post Treatment (Week 5)Population: Phase I participant arms are reported for this outcome because this was an a priori primary outcome for Phase I. Due to programming of the app, module completion was not tracked in the psychoeducation arm of the study.
Descriptive report of willingness to participate and program adherence. Phase I participant arms are reported for this outcome.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=35 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=25 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Number of Participants With Willingness to Participate and Program Adherence
% of eligible participants willing to participate
|
35 Participants
|
25 Participants
|
—
|
—
|
|
Number of Participants With Willingness to Participate and Program Adherence
% of enrolled participants completing all sessions by post-treatment
|
8 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Post-Treatment -"Week 5"Population: Participants who completed the post-treatment questionnaires.
Descriptive report of participant satisfaction (mood improvement and enjoyment) on a scale of 0-10, with 0 meaning lower satisfaction and 10 meaning higher satisfaction. Phase I participant arms are reported for this outcome.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=24 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=18 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Phase I - Feasibility (Satisfaction)
Participant Reported Mood Improvement
|
5.08 units on a scale
Standard Deviation 2.54
|
1.78 units on a scale
Standard Deviation 2.21
|
—
|
—
|
|
Phase I - Feasibility (Satisfaction)
Participant Reported Enjoyment
|
6.79 units on a scale
Standard Deviation 2.11
|
3.94 units on a scale
Standard Deviation 2.51
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline to Post Treatment (Week 5)Descriptive report of participant safety. Phase I participant arms are reported for this outcome.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=35 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=25 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Phase I - Feasibility (Safety)
Adverse Events
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase I - Feasibility (Safety)
Serious Adverse Events
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Phase I - Feasibility (Safety)
Adverse Device Effects
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase I - Feasibility (Safety)
Unanticipated Adverse Device Effects
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase I - Feasibility (Safety)
None
|
35 Participants
|
23 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Change from Baseline to Post treatment (5 weeks)Population: Participants who had a PHQ-8 score of ≥10 at Baseline. This was a Phase II Primary Outcome measure, so only Phase II arms are reported.
Between-subjects treatment-related change in depressive symptoms from baseline to 5-weeks as measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression) for those with baseline PHQ-8 ≥10.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=63 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=58 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Phase II - Change in Depressive Symptoms
|
-5.08 score on a scale
Interval -6.72 to -3.42
|
-3.51 score on a scale
Interval -5.09 to -1.93
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Post Treatment (Week 5)Population: Only Phase I participants were included in this Outcome measure.
Between-subjects treatment-related change in depressive symptoms from baseline to 5-weeks as measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression) for those with baseline PHQ-8 ≥5. Only Phase I participants were included in this Outcome measure.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=34 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=23 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Phase I - Change in Depression Symptoms
|
-3.89 score on a scale
Standard Deviation 5.29
|
-3.34 score on a scale
Standard Deviation 5.14
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Post Treatment (Week 5)Population: Participants with baseline PHQ-8 ≥ 10.
Remission rates based on PHQ-8 \< 10 (sub-analysis for those with baseline PHQ-8 ≥ 10). Phase I and Phase II participant arms are reported for this outcome.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=27 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=21 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
n=63 Participants
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
n=58 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Number of Participants in Remission
|
13 Participants
|
7 Participants
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Post Treatment (Week 5)Population: Participants who completed post-program questionnaires. Phase II participants were included if they had a baseline PHQ-8 score ≥ 10.
Between-subjects treatment-related change in participant-rated anxiety symptoms and global functioning as measured by GAD-7 Anxiety and PROMIS Pediatric Global Health Scale. The GAD-7 Anxiety is a brief 7-item assessment for generalized anxiety disorder. Values range from 0-21, with higher scores representing more severe anxiety. The PROMIS Pediatric Global Health Scale is a 7-item assessment for perceived physical, mental, and social health. Values range from 7-35, with higher scores representing better health. Phase I and Phase II participant arms are reported for this Outcome. Statistical Analyses are presented for Phase II results only because Phase I was intentionally not powered for analysis.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=30 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=21 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
n=43 Participants
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
n=49 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Change in Participant-rated Anxiety Symptoms and Global Functioning
GAD-7
|
-2.87 score on a scale
Standard Deviation 4.67
|
-2.29 score on a scale
Standard Deviation 3.94
|
-3.21 score on a scale
Standard Deviation 4.54
|
-1.45 score on a scale
Standard Deviation 3.33
|
|
Change in Participant-rated Anxiety Symptoms and Global Functioning
PROMIS - General Health
|
1.13 score on a scale
Standard Deviation 3.64
|
-0.14 score on a scale
Standard Deviation 2.69
|
1.35 score on a scale
Standard Deviation 3.41
|
-0.35 score on a scale
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: From Baseline to Post Treatment (Week 5)Population: Parent/Legal Guardians of participants \<18 years old who completed both baseline and post-treatment questionnaires. Phase II participants were included if they had a baseline PHQ-8 score ≥ 10.
Between-subjects treatment-related change in parent-reported depressive symptoms and global functioning as measured by Mood and Feelings Questionnaire (MFQ-PS), and PROMIS Parent Proxy Global Health Scale. The MFQ-PS consists of a series of 13 descriptive phrases regarding how the subject has been feeling or acting in the past two weeks and is a screening tool for depression in children and young people. Values range from 0-26, with higher scores representing more severe symptoms. The PROMIS Parent Proxy Global Health Scale is a 7-item assessment for perceived physical, mental, and social health. Values range from 7-35, with higher scores representing better health. Phase I and Phase II participant arms are reported for this Outcome. Statistical Analyses are presented for Phase II results only because Phase I was intentionally not powered for analysis.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=10 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=8 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
n=23 Participants
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
n=27 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Change in Parent-reported Depressive Symptoms and Global Functioning.
MFQ-SF
|
-4.20 score on a scale
Standard Deviation 5.49
|
-4.88 score on a scale
Standard Deviation 3.60
|
-4.83 score on a scale
Standard Deviation 4.31
|
-2.85 score on a scale
Standard Deviation 4.14
|
|
Change in Parent-reported Depressive Symptoms and Global Functioning.
PROMIS Parent Proxy - General Health
|
0.70 score on a scale
Standard Deviation 2.54
|
0.88 score on a scale
Standard Deviation 2.59
|
1.21 score on a scale
Standard Deviation 3.23
|
1.04 score on a scale
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: Post-TreatmentAverage treatment-related usability (System Usability Scale; SUS) and engagement (User Engagement Scale-Short Form; UES-SF) ratings. Phase I and Phase II participant arms are reported for this outcome. The SUS is a 10-item questionnaire measuring the usability of systems. Responses range from Strongly Agree to Strongly Disagree. Scores are percentile rankings and range from 0-100. Higher scores represent higher usability. The UES-SF is a 12-item questionnaire measuring self-reported user-engagement. The form uses a 5-point Likert scale. Overall engagement scores range from 1-5. Higher scores represent more engagement.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=30 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=21 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
n=43 Participants
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
n=49 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Average Treatment-related Usability and Engagement Ratings
SUS
|
80.67 units on a scale
Standard Error 2.17
|
75.83 units on a scale
Standard Error 2.29
|
82.85 units on a scale
Standard Error 1.89
|
76.12 units on a scale
Standard Error 1.92
|
|
Average Treatment-related Usability and Engagement Ratings
UES-SF
|
3.62 units on a scale
Standard Error 0.10
|
3.10 units on a scale
Standard Error 0.12
|
3.80 units on a scale
Standard Error 0.08
|
3.22 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: From Baseline to Post Treatment (Week 5)Between-group treatment-related differences in clinical concern rates and serious clinical concerns. Phase II participant arms are reported for this outcome.
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=80 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=80 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
Phase II - Safety
Adverse Events
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Phase II - Safety
Adverse Device Effects
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase II - Safety
Unanticipated Adverse Device Effects
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase II - Safety
Serious Adverse Events
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase II - Safety
None
|
76 Participants
|
78 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Post Treatment (Week 5)Between-group treatment-related differences in program adherence and engagement based on behavioral and mobile app analytics. Phase I and Phase II Spark participant arms are reported for this outcome. We are reporting the average number of app modules completed (out of 5 total modules).
Outcome measures
| Measure |
Number of Potentially Eligible Participants
n=35 Participants
The number of participants who expressed interest in participating in the study
|
Psychoeducation - Phase I
n=63 Participants
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation/Control Extension - Phase II
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark.
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
|---|---|---|---|---|
|
App Engagement and Adherence
|
2.74 app modules completed
Standard Deviation 1.69
|
3.17 app modules completed
Standard Deviation 1.82
|
—
|
—
|
Adverse Events
Limbix Spark - Phase I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychoeducation - Phase I
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Limbix Spark - Phase II
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Psychoeducation - Phase II
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Limbix Spark - Phase I
n=35 participants at risk
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase I
n=25 participants at risk
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
n=80 participants at risk
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase II
n=80 participants at risk
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
|---|---|---|---|---|
|
Psychiatric disorders
Hospitalized for a suicide attempt
|
0.00%
0/35 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
|
Psychiatric disorders
Hospitalized for "low mood"
|
0.00%
0/35 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
Other adverse events
| Measure |
Limbix Spark - Phase I
n=35 participants at risk
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase I
n=25 participants at risk
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
Limbix Spark - Phase II
n=80 participants at risk
A 5 week CBT-based intervention
Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
|
Psychoeducation - Phase II
n=80 participants at risk
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
|
|---|---|---|---|---|
|
Psychiatric disorders
Clinical Deterioration
|
0.00%
0/35 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/25 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
1.2%
1/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
2.5%
2/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/35 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/25 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
2.5%
2/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
|
Psychiatric disorders
Non-Suicidal Self-Injury Ideation
|
0.00%
0/35 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/25 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
1.2%
1/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
0.00%
0/80 • Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
|
Additional Information
Janel Shelton-DeMagnus, Research Operations Manager
Limbix Health
Phone: 8885462495
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place