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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).
Depression in adolescence is a public health crisis, with incidence and suicide rates rising sharply over the past decade. The COVID-19 global pandemic, along with mandated social and physical distancing, is expected to have substantial repercussions on public mental health and exacerbate the mental health crisis among teens. Adolescents, a group with significant unmet mental health needs, are at risk during this time, as they are especially vulnerable to depression and suicidality following environmental stressors, trauma, and social isolation that are endemic to this global pandemic. With difficulties in receiving in person care magnified during social distancing, now more than ever, there is an immediate need for safe, accessible, and effective digital treatments for mental health disorders.
The proposed intervention is intended to increase access to mental health care during the COVID-19 pandemic. This study aims to evaluate the clinical effectiveness and safety of a cognitive behavioral therapy (CBT)- based digital treatment for adolescent depression (Limbix Spark) relative to psychoeducation. Limbix Spark implements behavioral activation (BA), a key CBT skill that provides a sense of pleasure or mastery through self-monitored activities to reduce depressive symptoms and improve functional outcomes.
Adolescents with depression (13-21 years old) across the country will be recruited to participate in a fully remote, clinical trial via https://www.limbix.com/spark. At an initial virtual visit, following informed consent, adolescents and parents (for those under 18) will fill out standardized questionnaires designed to measure symptoms of depression, anxiety, and general health. Participants will then download an app onto their mobile phone and be randomly assigned to one of two groups. One group will receive the Limbix Spark program and the other will receive the Psychoeducation program for 5 weeks. The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and behavioral activation, and interactive activities including mood tracking and activity scheduling. The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression. During both 5 week programs, patients will also complete a weekly Patient Health Questionnaire, which is designed to measure depressive symptoms and also will report any negative side effects they may be experiencing. After 5 weeks, participants and legal guardians (for those under 18) will complete another set of standardized questionnaires designed to measure symptoms of depression, anxiety, and general health. Patients will also complete questionnaires asking them about their thoughts and experiences with the program they just completed. Lastly, a subset of patients and parents will be invited to complete a virtual interview to provide feedback on using the program.
The trial will be divided into two phases. The first phase will enroll 60 participants and participants will be randomized to either Spark and Control groups as described above. The second phase will enroll 175 participants and those randomized into the control group will be given access to the 5-week Spark intervention after completing the 5 weeks of control condition (control extension arm). Once completing the control extension arm, participants will complete a second set of post study questionnaires after 5 weeks.
All study participants that complete the 5-week Limbix Spark program and the post study questionnaires will be contacted and asked to consent to participation in the follow-up study. Only participants who did not opt-out to being contacted for future research will be contacted. This study will collect questionnaires from participants at any or all of the following time frames as indicated: 1-month, 3-month, and 6-month following completion of the Spark arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Limbix Spark | Experimental | A 5 week CBT-based intervention |
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| Psychoeducation | Active Comparator | 5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limbix Spark | Device | The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I - Feasibility (Eligibility) | 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. | Pre-enrollment |
| Number of Participants With Willingness to Participate and Program Adherence | Descriptive report of willingness to participate and program adherence. Phase I participant arms are reported for this outcome. | From Baseline to Post Treatment (Week 5) |
| Phase I - Feasibility (Satisfaction) | 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. | Post-Treatment -"Week 5" |
| Phase I - Feasibility (Safety) | Descriptive report of participant safety. Phase I participant arms are reported for this outcome. | From Baseline to Post Treatment (Week 5) |
| Phase II - Change in Depressive Symptoms | 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. | Change from Baseline to Post treatment (5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I - Change in Depression Symptoms | 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. | From Baseline to Post Treatment (Week 5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Lake, PhD | Director of Research | Principal Investigator |
| Aarthi Padmanabhan, Phd | Research Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limbix Health, Inc. | San Francisco | California | 94104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38324367 | Derived | Peake E, Miller I, Flannery J, Chen L, Lake J, Padmanabhan A. Preliminary Efficacy of a Digital Intervention for Adolescent Depression: Randomized Controlled Trial. J Med Internet Res. 2024 Feb 7;26:e48467. doi: 10.2196/48467. | |
| 37323125 | Derived | Kulikov VN, Crosthwaite PC, Hall SA, Flannery JE, Strauss GS, Vierra EM, Koepsell XL, Lake JI, Padmanabhan A. A CBT-based mobile intervention as an adjunct treatment for adolescents with symptoms of depression: a virtual randomized controlled feasibility trial. Front Digit Health. 2023 May 23;5:1062471. doi: 10.3389/fdgth.2023.1062471. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Limbix Spark - Phase I | A 5 week CBT-based intervention Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. |
| FG001 | Psychoeducation - Phase I | 5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression. |
| FG002 | Limbix Spark - Phase II | A 5 week CBT-based intervention Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. |
| FG003 | Psychoeducation - Phase II | 5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression. |
| FG004 | Control Extension - Phase II | Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark. Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I - Feasibility |
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| Phase II - Outcomes |
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| Phase II - Control Extension |
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| ID | Title | Description |
|---|---|---|
| BG000 | Limbix Spark - Phase I | A 5 week CBT-based intervention Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. |
| BG001 | Psychoeducation - Phase I |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase I - Feasibility (Eligibility) | 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. | People who expressed interest in participating in the study. | Posted | Count of Participants | Participants | Pre-enrollment |
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Adverse events were collected per patient during their 7-week (5 weeks of treatment program plus a 2 week post program questionnaire) duration of study participation. The entire duration of the study was from 30NOV2020 thru 03SEP2021.
Adverse events were monitored on a daily basis via the review of free form text that could be entered by participants throughout the study and from specific questions in the weekly symptom check and weekly PHQ-8 assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Limbix Spark - Phase I | A 5 week CBT-based intervention Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized for a suicide attempt | Psychiatric disorders | Systematic Assessment | Parent reported participant hospitalization because of suicide attempt |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinical Deterioration | Psychiatric disorders | Systematic Assessment | Clinical deterioration in PHQ for 2 consecutive weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janel Shelton-DeMagnus, Research Operations Manager | Limbix Health | 8885462495 | 709 | janel@limbix.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2021 | Sep 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Psychoeducation | Other | The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression. |
|
| Number of Participants in Remission | 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. | From Baseline to Post Treatment (Week 5) |
| Change in Participant-rated Anxiety Symptoms and Global Functioning | 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. | From Baseline to Post Treatment (Week 5) |
| Change in Parent-reported Depressive Symptoms and Global Functioning. | 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. | From Baseline to Post Treatment (Week 5) |
| Average Treatment-related Usability and Engagement Ratings | 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. | Post-Treatment |
| Phase II - Safety | Between-group treatment-related differences in clinical concern rates and serious clinical concerns. Phase II participant arms are reported for this outcome. | From Baseline to Post Treatment (Week 5) |
| App Engagement and Adherence | 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). | From Baseline to Post Treatment (Week 5) |
| Dropped for missing two consecutive weekly safety check-ins. |
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| Met PHQ-8 Threshold (Baseline >/= 10) | Participants who met this threshold were included in the intention-to-treat analysis and the per protocol analyses. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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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. |
| BG002 | Limbix Spark - Phase II | A 5 week CBT-based intervention Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. |
| BG003 | Psychoeducation/Control Extension - Phase II | 5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression. Participants who were initially assigned to the Psychoeducation control arm were given the opportunity to then complete the 5 week CBT-based intervention, Limbix Spark. Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants With Willingness to Participate and Program Adherence | Descriptive report of willingness to participate and program adherence. Phase I participant arms are reported for this outcome. | 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. | Posted | Count of Participants | Participants | From Baseline to Post Treatment (Week 5) |
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| Primary | Phase I - Feasibility (Satisfaction) | 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. | Participants who completed the post-treatment questionnaires. | Posted | Mean | Standard Deviation | units on a scale | Post-Treatment -"Week 5" |
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| Primary | Phase I - Feasibility (Safety) | Descriptive report of participant safety. Phase I participant arms are reported for this outcome. | Posted | Count of Participants | Participants | From Baseline to Post Treatment (Week 5) |
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| Primary | Phase II - Change in Depressive Symptoms | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Post treatment (5 weeks) |
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| Secondary | Phase I - Change in Depression Symptoms | 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. | Only Phase I participants were included in this Outcome measure. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Post Treatment (Week 5) |
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| Secondary | Number of Participants in Remission | 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. | Participants with baseline PHQ-8 ≥ 10. | Posted | Count of Participants | Participants | From Baseline to Post Treatment (Week 5) |
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| Secondary | Change in Participant-rated Anxiety Symptoms and Global Functioning | 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. | Participants who completed post-program questionnaires. Phase II participants were included if they had a baseline PHQ-8 score ≥ 10. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Post Treatment (Week 5) |
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| Secondary | Change in Parent-reported Depressive Symptoms and Global Functioning. | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Post Treatment (Week 5) |
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| Secondary | Average Treatment-related Usability and Engagement Ratings | 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. | Posted | Mean | Standard Error | units on a scale | Post-Treatment |
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| Secondary | Phase II - Safety | Between-group treatment-related differences in clinical concern rates and serious clinical concerns. Phase II participant arms are reported for this outcome. | Posted | Count of Participants | Participants | From Baseline to Post Treatment (Week 5) |
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| Secondary | App Engagement and Adherence | 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). | Posted | Mean | Standard Deviation | app modules completed | From Baseline to Post Treatment (Week 5) |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Psychoeducation - Phase I | 5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression. | 0 | 25 | 2 | 25 | 0 | 25 |
| EG002 | Limbix Spark - Phase II | A 5 week CBT-based intervention Limbix Spark: The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities. | 0 | 80 | 0 | 80 | 4 | 80 |
| EG003 | Psychoeducation - Phase II | 5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention Psychoeducation: The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression. | 0 | 80 | 0 | 80 | 2 | 80 |
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| Hospitalized for "low mood" | Psychiatric disorders | Systematic Assessment | Parent reported participant hospitalization for "low mood" |
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| Suicidal Ideation | Psychiatric disorders | Systematic Assessment | Participant reported suicidal ideation |
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| Non-Suicidal Self-Injury Ideation | Psychiatric disorders | Systematic Assessment | Parent reported that participant was experiencing Non-Suicidal Self-Injury ideation |
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| % of enrolled participants completing all sessions by post-treatment |
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| Adverse Device Effects |
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| Unanticipated Adverse Device Effects |
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| None |
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| We used a Per Protocol approach that included participants who completed the PHQ at baseline and each week. A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction. | Mixed Models Analysis | 0.01 | t | -2.546 | 2-Sided | Superiority |
| PROMIS - General Health |
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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.
| ANOVA |
| 0.11 |
| F |
| 2.59 |
| 2-Sided |
| Superiority |
| PROMIS Parent Proxy - General Health |
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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.
| ANOVA |
| 0.90 |
| F |
| 0.02 |
| 2-Sided |
| Superiority |
| UES-SF |
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| Adverse Device Effects |
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| Unanticipated Adverse Device Effects |
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| None |
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