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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title Limbix Spark - Phase I Psychoeducation - Phase I Limbix Spark - Phase II Psychoeducation/Control Extension - Phase II Total
Hide 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
Hide 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
1.Primary Outcome
Title Phase I - Feasibility (Eligibility)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
People who expressed interest in participating in the study.
Arm/Group Title Number of Potentially Eligible Participants
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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"
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the post-treatment questionnaires.
Arm/Group Title Limbix Spark - Phase I Psychoeducation - Phase I
Hide 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)
Hide Description Descriptive report of participant safety. Phase I participant arms are reported for this outcome.
Time Frame From Baseline to Post Treatment (Week 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Limbix Spark - Phase I Psychoeducation - Phase I
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only Phase I participants were included in this Outcome measure.
Arm/Group Title Limbix Spark - Phase I Psychoeducation - Phase I
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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.
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Limbix Spark - Phase I Psychoeducation - Phase I Limbix Spark - Phase II Psychoeducation/Control Extension - Phase II
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Limbix Spark - Phase II Psychoeducation - Phase II
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Limbix Spark - Phase I Limbix Spark - Phase II
Hide 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)
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
Hide 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%)    
Hide 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"
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Janel Shelton-DeMagnus, Research Operations Manager
Organization: Limbix Health
Phone: 8885462495 ext 709
EMail: janel@limbix.com
Layout table for additonal information
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