A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19

• ClinicalTrials.gov Identifier: NCT04524598
• Recruitment Status: Completed
• First Posted: August 24, 2020
• Results First Posted: December 13, 2021
• Last Update Posted: July 18, 2022
• Sponsor: Limbix Health, Inc.
• Information provided by (Responsible Party): Limbix Health, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Depression
• Interventions: Device: Limbix Spark; Other: Psychoeducation
• Enrollment: 227

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Limbix Spark - Phase I	Psychoeducation - Phase I	Limbix Spark - Phase II	Psychoeducation - Phase II	Control Extension - Phase II
Arm/Group Description	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.	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.	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.	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.
Period Title: Phase I - Feasibility
Started	35	25	0	0	0
Completed	31	20	0	0	0
Not Completed	4	5	0	0	0
Reason Not Completed
Lost to Follow-up	2	4	0	0	0
Dropped for missing two consecutive weekly safety check-ins.	2	1	0	0	0
Period Title: Phase II - Outcomes
Started	0	0	80	80	0
Met PHQ-8 Threshold (Baseline >/= 10) [1]	0	0	63	58	0
Completed	0	0	54	67	0
Not Completed	0	0	26	13	0
Reason Not Completed
Lost to Follow-up	0	0	16	8	0
Withdrawal by Subject	0	0	2	0	0
Dropped for missing two consecutive weekly safety check-ins.	0	0	8	5	0
[1] Participants who met this threshold were included in the intention-to-treat analysis and the per protocol analyses.
Period Title: Phase II - Control Extension
Started	0	0	0	0	66
Completed	0	0	0	0	54
Not Completed	0	0	0	0	12
Reason Not Completed
Lost to Follow-up	0	0	0	0	6
Dropped for missing two consecutive weekly safety check-ins.	0	0	0	0	6

Baseline Characteristics

Arm/Group Title		Limbix Spark - Phase I	Psychoeducation - Phase I	Limbix Spark - Phase II	Psychoeducation/Control Extension - Phase II	Total
Arm/Group Description		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.	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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		35	25	63	58	181
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	35 participants	25 participants	63 participants	58 participants	181 participants
	<=18 years	18 51.4%	17 68.0%	33 52.4%	35 60.3%	103 56.9%
	Between 18 and 65 years	17 48.6%	8 32.0%	30 47.6%	23 39.7%	78 43.1%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	35 participants	25 participants	63 participants	58 participants	181 participants
		18 (2.36)	17 (2.57)	17.06 (2.49)	16.46 (2.43)	16.78 (2.47)
Sex/Gender, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Participant Reported Gender	Number Analyzed	35 participants	25 participants	63 participants	58 participants	181 participants
	Female	28 80.0%	19 76.0%	42 66.7%	39 67.2%	128 70.7%
	Male	6 17.1%	5 20.0%	16 25.4%	10 17.2%	37 20.4%
	Non-Binary	1 2.9%	1 4.0%	5 7.9%	9 15.5%	16 8.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	35 participants	25 participants	63 participants	58 participants	181 participants
	Hispanic or Latino	6 17.1%	4 16.0%	11 17.5%	8 13.8%	29 16.0%
	Not Hispanic or Latino	29 82.9%	21 84.0%	46 73.0%	47 81.0%	143 79.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	6 9.5%	3 5.2%	9 5.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	35 participants	25 participants	63 participants	58 participants	181 participants
	American Indian or Alaska Native	1 2.9%	0 0.0%	1 1.6%	2 3.4%	4 2.2%
	Asian	7 20.0%	4 16.0%	4 6.3%	0 0.0%	15 8.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 5.7%	3 12.0%	3 4.8%	2 3.4%	10 5.5%
	White	20 57.1%	17 68.0%	47 74.6%	45 77.6%	129 71.3%
	More than one race	3 8.6%	1 4.0%	8 12.7%	8 13.8%	20 11.0%
	Unknown or Not Reported	2 5.7%	0 0.0%	0 0.0%	1 1.7%	3 1.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	35 participants	25 participants	63 participants	58 participants	181 participants
		35	25	63	58	121

Outcome Measures

1. Primary Outcome

Title	Phase I - Feasibility (Eligibility)
Description	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.
Time Frame	Pre-enrollment

Outcome Measure Data

Analysis Population Description

People who expressed interest in participating in the study.

Arm/Group Title	Number of Potentially Eligible Participants
Arm/Group Description:	The number of participants who expressed interest in participating in the study
Overall Number of Participants Analyzed	150
Measure Type: Count of Participants; Unit of Measure: Participants
Limbix Spark - Phase I	35 23.3%
Psychoeducation - Phase I	25 16.7%

2. Primary Outcome

Title	Number of Participants With Willingness to Participate and Program Adherence
Description	Descriptive report of willingness to participate and program adherence. Phase I participant arms are reported for this outcome.
Time Frame	From Baseline to Post Treatment (Week 5)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Limbix Spark - Phase I	Psychoeducation - Phase I
Arm/Group Description:		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.	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.
Overall Number of Participants Analyzed		35	25
Measure Type: Count of Participants; Unit of Measure: Participants
% of eligible participants willing to participate	Number Analyzed	35 participants	25 participants
		35 100.0%	25 100.0%
% of enrolled participants completing all sessions by post-treatment	Number Analyzed	35 participants	0 participants
		8 22.9%

3. Primary Outcome

Title	Phase I - Feasibility (Satisfaction)
Description	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.
Time Frame	Post-Treatment -"Week 5"

Outcome Measure Data

Analysis Population Description

Participants who completed the post-treatment questionnaires.

Arm/Group Title	Limbix Spark - Phase I	Psychoeducation - Phase I
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	24	18
Mean (Standard Deviation); Unit of Measure: units on a scale
Participant Reported Mood Improvement	5.08 (2.54)	1.78 (2.21)
Participant Reported Enjoyment	6.79 (2.11)	3.94 (2.51)

4. Primary Outcome

Title	Phase I - Feasibility (Safety)
Description	Descriptive report of participant safety. Phase I participant arms are reported for this outcome.
Time Frame	From Baseline to Post Treatment (Week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Limbix Spark - Phase I	Psychoeducation - Phase I
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	35	25
Measure Type: Count of Participants; Unit of Measure: Participants
Adverse Events	0 0.0%	0 0.0%
Serious Adverse Events	0 0.0%	2 8.0%
Adverse Device Effects	0 0.0%	0 0.0%
Unanticipated Adverse Device Effects	0 0.0%	0 0.0%
None	35 100.0%	23 92.0%

5. Primary Outcome

Title	Phase II - Change in Depressive Symptoms
Description	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.
Time Frame	Change from Baseline to Post treatment (5 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Limbix Spark - Phase II	Psychoeducation - Phase II
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	63	58
Mean (Standard Deviation); Unit of Measure: score on a scale
	-5.19 (4.61)	-3.58 (4.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Limbix Spark - Phase II, Psychoeducation - Phase II
	Comments	We took an intention-to-treat approach and imputed missing data. We used a generalized linear mixed-effect model (GLMM) with multiple imputation (MI) using a 2-level PAN method (Schafer & Yucel, 2002) for this analysis and controlled for irregular spacing by adding it as a random-effect for the slope at the individual level.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.076
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	F
	Estimated Value	3.152
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Limbix Spark - Phase II, Psychoeducation - Phase II
	Comments	We used a Per Protocol approach that included participants who completed the PHQ at baseline and each week. We used a generalized linear mixed-effect model (GLM) with the effect of irregular spacing controlled by adding it as a random-effect for the slope at the individual level.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.023
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	t
	Estimated Value	-2.306
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Phase I - Change in Depression Symptoms
Description	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.
Time Frame	From Baseline to Post Treatment (Week 5)

Outcome Measure Data

Analysis Population Description

Only Phase I participants were included in this Outcome measure.

Arm/Group Title	Limbix Spark - Phase I	Psychoeducation - Phase I
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	34	23
Mean (Standard Deviation); Unit of Measure: score on a scale
	-3.89 (5.29)	-3.34 (5.14)

7. Secondary Outcome

Title	Number of Participants in Remission
Description	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.
Time Frame	From Baseline to Post Treatment (Week 5)

Outcome Measure Data

Analysis Population Description

Participants with baseline PHQ-8 ≥ 10.

Arm/Group Title	Limbix Spark - Phase I	Psychoeducation - Phase I	Limbix Spark - Phase II	Psychoeducation/Control Extension - Phase II
Arm/Group Description:	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.	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.	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.	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.
Overall Number of Participants Analyzed	27	21	63	58
Measure Type: Count of Participants; Unit of Measure: Participants
	13 48.1%	7 33.3%	11 17.5%	2 3.4%

8. Secondary Outcome

Title	Change in Participant-rated Anxiety Symptoms and Global Functioning
Description	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.
Time Frame	From Baseline to Post Treatment (Week 5)

Outcome Measure Data

Analysis Population Description

Participants who completed post-program questionnaires. Phase II participants were included if they had a baseline PHQ-8 score ≥ 10.

Arm/Group Title	Limbix Spark - Phase I	Psychoeducation - Phase I	Limbix Spark - Phase II	Psychoeducation/Control Extension - Phase II
Arm/Group Description:	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.	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.	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.	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.
Overall Number of Participants Analyzed	30	21	43	49
Mean (Standard Deviation); Unit of Measure: score on a scale
GAD-7	-2.87 (4.67)	-2.29 (3.94)	-3.21 (4.54)	-1.45 (3.33)
PROMIS - General Health	1.13 (3.64)	-0.14 (2.69)	1.35 (3.41)	-0.35 (1.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Limbix Spark - Phase II, Psychoeducation/Control Extension - Phase II
	Comments	We conducted a repeated measures ANOVA (Group x Time) on GAD-7 scores to compare the change in anxiety symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score >= 10. The interaction term is presented.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.23
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	F
	Estimated Value	1.46
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Limbix Spark - Phase II, Psychoeducation/Control Extension - Phase II
	Comments	We conducted a repeated measures ANOVA (Group x Time) on the PROMIS - General Health Score to compare the change in general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score >= 10. The interaction term is reported.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.11
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	F
	Estimated Value	2.59
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Change in Parent-reported Depressive Symptoms and Global Functioning.
Description	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.
Time Frame	From Baseline to Post Treatment (Week 5)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Limbix Spark - Phase I	Psychoeducation - Phase I	Limbix Spark - Phase II	Psychoeducation/Control Extension - Phase II
Arm/Group Description:	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.	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.	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.	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.
Overall Number of Participants Analyzed	10	8	23	27
Mean (Standard Deviation); Unit of Measure: score on a scale
MFQ-SF	-4.20 (5.49)	-4.88 (3.60)	-4.83 (4.31)	-2.85 (4.14)
PROMIS Parent Proxy - General Health	0.70 (2.54)	0.88 (2.59)	1.21 (3.23)	1.04 (2.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Limbix Spark - Phase II, Psychoeducation/Control Extension - Phase II
	Comments	We conducted a repeated measures ANOVA (Time x Group) on the MFQ to compare the change in parent report of depressive symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score >= 10. The interaction term is presented.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.33
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	F
	Estimated Value	0.94
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Limbix Spark - Phase II, Psychoeducation/Control Extension - Phase II
	Comments	We conducted a repeated measures ANOVA (Group x Time) on the PROMIS Parent Proxy - General Health Score to compare the change in parent reported general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score >= 10. The interaction term is reported.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.90
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	F
	Estimated Value	0.02
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Average Treatment-related Usability and Engagement Ratings
Description	Average 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.
Time Frame	Post-Treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Limbix Spark - Phase I	Psychoeducation - Phase I	Limbix Spark - Phase II	Psychoeducation/Control Extension - Phase II
Arm/Group Description:	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.	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.	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.	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.
Overall Number of Participants Analyzed	30	21	43	49
Mean (Standard Error); Unit of Measure: units on a scale
SUS	80.67 (2.17)	75.83 (2.29)	82.85 (1.89)	76.12 (1.92)
UES-SF	3.62 (0.10)	3.10 (0.12)	3.80 (0.08)	3.22 (0.09)

11. Secondary Outcome

Title	Phase II - Safety
Description	Between-group treatment-related differences in clinical concern rates and serious clinical concerns. Phase II participant arms are reported for this outcome.
Time Frame	From Baseline to Post Treatment (Week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Limbix Spark - Phase II	Psychoeducation - Phase II
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	80	80
Measure Type: Count of Participants; Unit of Measure: Participants
Adverse Events	4 5.0%	2 2.5%
Serious Adverse Events	0 0.0%	0 0.0%
Adverse Device Effects	0 0.0%	0 0.0%
Unanticipated Adverse Device Effects	0 0.0%	0 0.0%
None	76 95.0%	78 97.5%

12. Secondary Outcome

Title	App Engagement and Adherence
Description	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).
Time Frame	From Baseline to Post Treatment (Week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Limbix Spark - Phase I	Limbix Spark - Phase II
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	35	63
Mean (Standard Deviation); Unit of Measure: app modules completed
	2.74 (1.69)	3.17 (1.82)

Adverse Events

Time Frame	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 Event Reporting Description	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.
Arm/Group Title	Limbix Spark - Phase I		Psychoeducation - Phase I		Limbix Spark - Phase II		Psychoeducation - Phase II
Arm/Group Description	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.		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.		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.		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.
All-Cause Mortality
	Limbix Spark - Phase I		Psychoeducation - Phase I		Limbix Spark - Phase II		Psychoeducation - Phase II
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/35 (0.00%)		0/25 (0.00%)		0/80 (0.00%)		0/80 (0.00%)
Serious Adverse Events
	Limbix Spark - Phase I		Psychoeducation - Phase I		Limbix Spark - Phase II		Psychoeducation - Phase II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0.00%)		2/25 (8.00%)		0/80 (0.00%)		0/80 (0.00%)
Psychiatric disorders
Hospitalized for a suicide attempt † [1]	0/35 (0.00%)	0	1/25 (4.00%)	1	0/80 (0.00%)	0	0/80 (0.00%)	0
Hospitalized for "low mood" † [2]	0/35 (0.00%)	0	1/25 (4.00%)	1	0/80 (0.00%)	0	0/80 (0.00%)	0
† Indicates events were collected by systematic assessment; [1] Parent reported participant hospitalization because of suicide attempt; [2] Parent reported participant hospitalization for "low mood"
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Limbix Spark - Phase I		Psychoeducation - Phase I		Limbix Spark - Phase II		Psychoeducation - Phase II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0.00%)		0/25 (0.00%)		4/80 (5.00%)		2/80 (2.50%)
Psychiatric disorders
Clinical Deterioration † [1]	0/35 (0.00%)		0/25 (0.00%)		1/80 (1.25%)		2/80 (2.50%)
Suicidal Ideation † [2]	0/35 (0.00%)		0/25 (0.00%)		2/80 (2.50%)		0/80 (0.00%)
Non-Suicidal Self-Injury Ideation † [3]	0/35 (0.00%)		0/25 (0.00%)		1/80 (1.25%)		0/80 (0.00%)
† Indicates events were collected by systematic assessment; [1] Clinical deterioration in PHQ for 2 consecutive weeks; [2] Participant reported suicidal ideation; [3] Parent reported that participant was experiencing Non-Suicidal Self-Injury ideation

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Janel Shelton-DeMagnus, Research Operations Manager
• Organization: Limbix Health
• Phone: 8885462495 ext 709
• EMail: janel@limbix.com

• Responsible Party: Limbix Health, Inc.
• ClinicalTrials.gov Identifier: NCT04524598
• Other Study ID Numbers: Limbix Spark 02
• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Results First Submitted: September 30, 2021
• Results First Posted: December 13, 2021
• Last Update Posted: July 18, 2022