A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19
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ClinicalTrials.gov Identifier: NCT04524598 |
Recruitment Status :
Completed
First Posted : August 24, 2020
Results First Posted : December 13, 2021
Last Update Posted : July 18, 2022
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Study Type | Interventional |
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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 |
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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.
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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 | |
---|---|---|---|---|---|---|
![]() |
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 | |
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[Not Specified]
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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%
|
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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%
|
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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%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 35 participants | 25 participants | 63 participants | 58 participants | 181 participants |
35 | 25 | 63 | 58 | 121 |
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 |