NCT04524598

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

Completed NA Results posted Last updated 18 May 2023

What this trial tests

NA trial testing Limbix Spark in Depression in 227 participants. Completed in 16 January 2022.

Timeline

20 July 2020

Primary endpoint
3 September 2021

16 January 2022

Quick facts

Lead sponsor	Limbix Health, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	227
Start date	20 July 2020
Primary completion	3 September 2021
Estimated completion	16 January 2022
Sites	1 location across United States

Drugs / interventions tested

• Limbix Spark
• Psychoeducation

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Limbix Health, Inc.

Who can join

Adults 13 to 21, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase I - Feasibility (Eligibility) Primary · Pre-enrollment

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.

Limbix Spark - Phase I

Group	Value	95% CI
Number of Potentially Eligible Participants	35

Psychoeducation - Phase I

Group	Value	95% CI
Number of Potentially Eligible Participants	25

Number of Participants With Willingness to Participate and Program Adherence Primary · From Baseline to Post Treatment (Week 5)

Descriptive report of willingness to participate and program adherence. Phase I participant arms are reported for this outcome.

% of eligible participants willing to participate

Group	Value	95% CI
Limbix Spark - Phase I	35
Psychoeducation - Phase I	25

% of enrolled participants completing all sessions by post-treatment

Group	Value	95% CI
Limbix Spark - Phase I	8

Phase I - Feasibility (Satisfaction) Primary · Post-Treatment -"Week 5"

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.

Participant Reported Mood Improvement

Group	Value	95% CI
Limbix Spark - Phase I	5.08	± 2.54
Psychoeducation - Phase I	1.78	± 2.21

Participant Reported Enjoyment

Group	Value	95% CI
Limbix Spark - Phase I	6.79	± 2.11
Psychoeducation - Phase I	3.94	± 2.51

Phase I - Feasibility (Safety) Primary · From Baseline to Post Treatment (Week 5)

Descriptive report of participant safety. Phase I participant arms are reported for this outcome.

Adverse Events

Group	Value	95% CI
Limbix Spark - Phase I	0
Psychoeducation - Phase I	0

Serious Adverse Events

Group	Value	95% CI
Limbix Spark - Phase I	0
Psychoeducation - Phase I	2

Adverse Device Effects

Group	Value	95% CI
Limbix Spark - Phase I	0
Psychoeducation - Phase I	0

Unanticipated Adverse Device Effects

Group	Value	95% CI
Limbix Spark - Phase I	0
Psychoeducation - Phase I	0

None

Group	Value	95% CI
Limbix Spark - Phase I	35
Psychoeducation - Phase I	23

Phase II - Change in Depressive Symptoms Primary · Change from Baseline to Post treatment (5 weeks)

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.

Group	Value	95% CI
Limbix Spark - Phase II	-5.08	-6.72 – -3.42
Psychoeducation - Phase II	-3.51	-5.09 – -1.93

Phase I - Change in Depression Symptoms Secondary · From Baseline to Post Treatment (Week 5)

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.

Group	Value	95% CI
Limbix Spark - Phase I	-3.89	± 5.29
Psychoeducation - Phase I	-3.34	± 5.14

Number of Participants in Remission Secondary · From Baseline to Post Treatment (Week 5)

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.

Group	Value	95% CI
Limbix Spark - Phase I	13
Psychoeducation - Phase I	7
Limbix Spark - Phase II	11
Psychoeducation/Control Extension - Phase II	2

Change in Participant-rated Anxiety Symptoms and Global Functioning Secondary · From Baseline to Post Treatment (Week 5)

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. Statistica

GAD-7

Group	Value	95% CI
Limbix Spark - Phase I	-2.87	± 4.67
Psychoeducation - Phase I	-2.29	± 3.94
Limbix Spark - Phase II	-3.21	± 4.54
Psychoeducation/Control Extension - Phase II	-1.45	± 3.33

PROMIS - General Health

Group	Value	95% CI
Limbix Spark - Phase I	1.13	± 3.64
Psychoeducation - Phase I	-0.14	± 2.69
Limbix Spark - Phase II	1.35	± 3.41
Psychoeducation/Control Extension - Phase II	-0.35	± 1.85

Change in Parent-reported Depressive Symptoms and Global Functioning. Secondary · From Baseline to Post Treatment (Week 5)

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 he

MFQ-SF

Group	Value	95% CI
Limbix Spark - Phase I	-4.20	± 5.49
Psychoeducation - Phase I	-4.88	± 3.60
Limbix Spark - Phase II	-4.83	± 4.31
Psychoeducation/Control Extension - Phase II	-2.85	± 4.14

PROMIS Parent Proxy - General Health

Group	Value	95% CI
Limbix Spark - Phase I	0.70	± 2.54
Psychoeducation - Phase I	0.88	± 2.59
Limbix Spark - Phase II	1.21	± 3.23
Psychoeducation/Control Extension - Phase II	1.04	± 2.47

Average Treatment-related Usability and Engagement Ratings Secondary · Post-Treatment

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

SUS

Group	Value	95% CI
Limbix Spark - Phase I	80.67	± 2.17
Psychoeducation - Phase I	75.83	± 2.29
Limbix Spark - Phase II	82.85	± 1.89
Psychoeducation/Control Extension - Phase II	76.12	± 1.92

UES-SF

Group	Value	95% CI
Limbix Spark - Phase I	3.62	± 0.10
Psychoeducation - Phase I	3.10	± 0.12
Limbix Spark - Phase II	3.80	± 0.08
Psychoeducation/Control Extension - Phase II	3.22	± 0.09

Phase II - Safety Secondary · 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.

Group	Value	95% CI
Limbix Spark - Phase II	4
Psychoeducation - Phase II	2
Limbix Spark - Phase II	0
Psychoeducation - Phase II	0
Limbix Spark - Phase II	0
Psychoeducation - Phase II	0
Limbix Spark - Phase II	0
Psychoeducation - Phase II	0

App Engagement and Adherence Secondary · 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).

Group	Value	95% CI
Limbix Spark - Phase I	2.74	± 1.69
Limbix Spark - Phase II	3.17	± 1.82

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Limbix Spark - Phase I

Serious: 0/35 (0%)

Deaths: 0/35

Psychoeducation - Phase I

Serious: 2/25 (8%)

Deaths: 0/25

Limbix Spark - Phase II

Serious: 0/80 (0%)

Deaths: 0/80

Psychoeducation - Phase II

Serious: 0/80 (0%)

Deaths: 0/80

Serious adverse events (2 terms)

Reaction	System	Limbix Spark - Phase I	Psychoeducation - Phase I	Limbix Spark - Phase II	Psychoeducation - Phase II
Hospitalized for a suicide attempt	Psychiatric disorders	—	—	—	—
Hospitalized for "low mood"	Psychiatric disorders	—	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Limbix Spark - Phase I	Psychoeducation - Phase I	Limbix Spark - Phase II	Psychoeducation - Phase II
Clinical Deterioration	Psychiatric disorders	—	—	—	—
Suicidal Ideation	Psychiatric disorders	—	—	—	—
Non-Suicidal Self-Injury Ideation	Psychiatric disorders	—	—	—	—

Most-reported serious reactions: Hospitalized for a suicide attempt, Hospitalized for "low mood".

Data from ClinicalTrials.gov NCT04524598 adverse events section.

Sponsor's own description

Over 3 million teenagers in the USA have depression, and rates of depression and suicide are sharply increasing. Teenage depression has far-reaching consequences including impairments in academic and work performance and social and family relationships, substance abuse, and worsening of other health conditions, which can persist into adulthood. Access to mental health care for teenagers is limited due to a shortage of mental health providers and many teenagers and parents are reluctant to take antidepressants. COVID-19 and mandated physical and social distancing is expected to increase rates of teenage depression, and further limit access to traditional methods of care (e.g. psychotherapy). This highlights an urgent need to develop accessible, digital treatments for teenage depression to address the serious mental health impacts of the COVID-19 pandemic. This fully virtual study (https://www.limbix.com/spark) will compare the relative safety, effectiveness, and engagement of a mobile application based on cognitive behavioral therapy and behavioral activation (Limbix Spark), focusing on the idea that engaging in behaviors that are rewarding or provide a sense of mastery can be effective in reducing symptoms of depression. Limbix Spark will be compared to a mobile app containing educational material about depression (Psychoeducation).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Addressing Pediatric Mental Health Using Telehealth During Coronavirus Disease-2019 and Beyond: A Narrative Review.
   Cunningham NR, Ely SL, Barber Garcia BN, Bowden J. · · 2021 · cited 44× · PMID 34118499 · DOI 10.1016/j.acap.2021.06.002
2. A CBT-based mobile intervention as an adjunct treatment for adolescents with symptoms of depression: a virtual randomized controlled feasibility trial.
   Kulikov VN, Crosthwaite PC, Hall SA, Flannery JE, et al · · 2023 · cited 16× · PMID 37323125 · DOI 10.3389/fdgth.2023.1062471
3. Preliminary Efficacy of a Digital Intervention for Adolescent Depression: Randomized Controlled Trial.
   Peake E, Miller I, Flannery J, Chen L, et al · · 2024 · cited 15× · PMID 38324367 · DOI 10.2196/48467
4. Advances in the prevalence and treatment of depression for adolescents: a review.
   Yin C, Xu M, Zong Z. · · 2025 · cited 2× · PMID 40406494 · DOI 10.3389/fphar.2025.1574574