Depression
Conditions
Keywords
Adolescence, Digital Therapeutic, Cognitive Behavioral Therapy, Behavioral Activation
Brief summary
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).
Detailed description
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.
Interventions
DEVICELimbix Spark
The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
OTHERPsychoeducation
The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
Sponsors
Limbix Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 13 and 21 * Self-reported symptoms of depression * Will be residing in the USA for the duration of the 5-week study * Under the care of a US-based primary care and/or licensed mental healthcare provider and willing and able to provide the name and contact information of the provider during consent appointment. * English fluency and literacy of adolescent and consenting legal guardian if under 18 * Access to a smartphone (iPhone 5s or later or running Android 4.4 KitKat or later) and regular internet access * Willing to provide informed e-consent/assent and have legal guardian willing to provide informed e-consent if under 18.
Exclusion criteria
* Self-reported lifetime suicide attempt or active self-harm or active suicidal ideation with intent * Have a diagnosis by a clinician of bipolar disorder, substance use disorder, or any psychotic disorder including schizophrenia * Incapable of understanding or completing study procedures and digital intervention as determined by participant, patient/legal guardian, healthcare provider, or clinical research team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I - Feasibility (Eligibility) | 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. |
| Number of Participants With Willingness to Participate and Program Adherence | 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. |
| Phase I - Feasibility (Satisfaction) | 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. |
| Phase I - Feasibility (Safety) | From Baseline to Post Treatment (Week 5) | Descriptive report of participant safety. Phase I participant arms are reported for this outcome. |
| Phase II - Change in Depressive Symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase II - Safety | 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. |
| Phase I - Change in Depression Symptoms | 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. |
| App Engagement and Adherence | 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). |
| Number of Participants in Remission | 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. |
| Change in Participant-rated Anxiety Symptoms and Global Functioning | 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. Statistical Analyses are presented for Phase II results only because Phase I was intentionally not powered for analysis. |
| Change in Parent-reported Depressive Symptoms and Global Functioning. | 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 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. |
| Average Treatment-related Usability and Engagement Ratings | 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 represent more engagement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 25 |
| 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. | 63 |
| 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. | 58 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Phase I - Feasibility | Dropped for missing two consecutive weekly safety check-ins. | 2 | 1 | 0 | 0 | 0 |
| Phase I - Feasibility | Lost to Follow-up | 2 | 4 | 0 | 0 | 0 |
| Phase II - Control Extension | Dropped for missing two consecutive weekly safety check-ins. | 0 | 0 | 0 | 0 | 6 |
| Phase II - Control Extension | Lost to Follow-up | 0 | 0 | 0 | 0 | 6 |
| Phase II - Outcomes | Dropped for missing two consecutive weekly safety check-ins. | 0 | 0 | 8 | 5 | 0 |
| Phase II - Outcomes | Lost to Follow-up | 0 | 0 | 16 | 8 | 0 |
| Phase II - Outcomes | Withdrawal by Subject | 0 | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 17 Participants | 33 Participants | 35 Participants | 103 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 8 Participants | 30 Participants | 23 Participants | 78 Participants |
| Age, Continuous | 18 years STANDARD_DEVIATION 2.36 | 17 years STANDARD_DEVIATION 2.57 | 17.06 years STANDARD_DEVIATION 2.49 | 16.46 years STANDARD_DEVIATION 2.43 | 16.78 years STANDARD_DEVIATION 2.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 11 Participants | 8 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 21 Participants | 46 Participants | 47 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 4 Participants | 4 Participants | 0 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 8 Participants | 8 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 20 Participants | 17 Participants | 47 Participants | 45 Participants | 129 Participants |
| Region of Enrollment United States | 35 participants | 25 participants | 63 participants | 58 participants | 121 participants |
| Sex/Gender, Customized Participant Reported Gender Female | 28 Participants | 19 Participants | 42 Participants | 39 Participants | 128 Participants |
| Sex/Gender, Customized Participant Reported Gender Male | 6 Participants | 5 Participants | 16 Participants | 10 Participants | 37 Participants |
| Sex/Gender, Customized Participant Reported Gender Non-Binary | 1 Participants | 1 Participants | 5 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 25 | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 0 / 35 | 0 / 25 | 4 / 80 | 2 / 80 |
| serious Total, serious adverse events | 0 / 35 | 2 / 25 | 0 / 80 | 0 / 80 |
Outcome results
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.
Time frame: From Baseline to Post Treatment (Week 5)
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Number of Potentially Eligible Participants | Number of Participants With Willingness to Participate and Program Adherence | % of eligible participants willing to participate | 35 Participants |
| Number of Potentially Eligible Participants | Number of Participants With Willingness to Participate and Program Adherence | % of enrolled participants completing all sessions by post-treatment | 8 Participants |
| Psychoeducation - Phase I | Number of Participants With Willingness to Participate and Program Adherence | % of eligible participants willing to participate | 25 Participants |
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.
Time frame: Pre-enrollment
Population: People who expressed interest in participating in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Number of Potentially Eligible Participants | Phase I - Feasibility (Eligibility) | Limbix Spark - Phase I | 35 Participants |
| Number of Potentially Eligible Participants | Phase I - Feasibility (Eligibility) | Psychoeducation - Phase I | 25 Participants |
Primary
Phase I - Feasibility (Safety)
Descriptive report of participant safety. Phase I participant arms are reported for this outcome.
Time frame: From Baseline to Post Treatment (Week 5)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Number of Potentially Eligible Participants | Phase I - Feasibility (Safety) | Serious Adverse Events | 0 Participants |
| Number of Potentially Eligible Participants | Phase I - Feasibility (Safety) | Unanticipated Adverse Device Effects | 0 Participants |
| Number of Potentially Eligible Participants | Phase I - Feasibility (Safety) | Adverse Device Effects | 0 Participants |
| Number of Potentially Eligible Participants | Phase I - Feasibility (Safety) | None | 35 Participants |
| Number of Potentially Eligible Participants | Phase I - Feasibility (Safety) | Adverse Events | 0 Participants |
| Psychoeducation - Phase I | Phase I - Feasibility (Safety) | None | 23 Participants |
| Psychoeducation - Phase I | Phase I - Feasibility (Safety) | Adverse Events | 0 Participants |
| Psychoeducation - Phase I | Phase I - Feasibility (Safety) | Serious Adverse Events | 2 Participants |
| Psychoeducation - Phase I | Phase I - Feasibility (Safety) | Adverse Device Effects | 0 Participants |
| Psychoeducation - Phase I | Phase I - Feasibility (Safety) | Unanticipated Adverse Device Effects | 0 Participants |
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.
Time frame: Post-Treatment -Week 5
Population: Participants who completed the post-treatment questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Number of Potentially Eligible Participants | Phase I - Feasibility (Satisfaction) | Participant Reported Mood Improvement | 5.08 units on a scale | Standard Deviation 2.54 |
| Number of Potentially Eligible Participants | Phase I - Feasibility (Satisfaction) | Participant Reported Enjoyment | 6.79 units on a scale | Standard Deviation 2.11 |
| Psychoeducation - Phase I | Phase I - Feasibility (Satisfaction) | Participant Reported Mood Improvement | 1.78 units on a scale | Standard Deviation 2.21 |
| Psychoeducation - Phase I | Phase I - Feasibility (Satisfaction) | Participant Reported Enjoyment | 3.94 units on a scale | Standard Deviation 2.51 |
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.
Time frame: Change from Baseline to Post treatment (5 weeks)
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Number of Potentially Eligible Participants | Phase II - Change in Depressive Symptoms | -5.08 score on a scale |
| Psychoeducation - Phase I | Phase II - Change in Depressive Symptoms | -3.51 score on a scale |
Comparison: 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. Group and Week were entered as fixed factors. Spark version, and assessment completion days since baseline were included as fixed factors to control for effects of app version and differences in time between completion of successive weekly assessments.p-value: 0.06Mixed Models Analysis
Comparison: 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.p-value: 0.01Mixed Models Analysis
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).
Time frame: From Baseline to Post Treatment (Week 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Number of Potentially Eligible Participants | App Engagement and Adherence | 2.74 app modules completed | Standard Deviation 1.69 |
| Psychoeducation - Phase I | App Engagement and Adherence | 3.17 app modules completed | Standard Deviation 1.82 |
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.
Time frame: Post-Treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Number of Potentially Eligible Participants | Average Treatment-related Usability and Engagement Ratings | SUS | 80.67 units on a scale | Standard Error 2.17 |
| Number of Potentially Eligible Participants | Average Treatment-related Usability and Engagement Ratings | UES-SF | 3.62 units on a scale | Standard Error 0.1 |
| Psychoeducation - Phase I | Average Treatment-related Usability and Engagement Ratings | UES-SF | 3.10 units on a scale | Standard Error 0.12 |
| Psychoeducation - Phase I | Average Treatment-related Usability and Engagement Ratings | SUS | 75.83 units on a scale | Standard Error 2.29 |
| Limbix Spark - Phase II | Average Treatment-related Usability and Engagement Ratings | SUS | 82.85 units on a scale | Standard Error 1.89 |
| Limbix Spark - Phase II | Average Treatment-related Usability and Engagement Ratings | UES-SF | 3.80 units on a scale | Standard Error 0.08 |
| Psychoeducation/Control Extension - Phase II | Average Treatment-related Usability and Engagement Ratings | SUS | 76.12 units on a scale | Standard Error 1.92 |
| Psychoeducation/Control Extension - Phase II | Average Treatment-related Usability and Engagement Ratings | UES-SF | 3.22 units on a scale | Standard Error 0.09 |
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.
Time frame: From Baseline to Post Treatment (Week 5)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Number of Potentially Eligible Participants | Change in Parent-reported Depressive Symptoms and Global Functioning. | MFQ-SF | -4.20 score on a scale | Standard Deviation 5.49 |
| Number of Potentially Eligible Participants | Change in Parent-reported Depressive Symptoms and Global Functioning. | PROMIS Parent Proxy - General Health | 0.70 score on a scale | Standard Deviation 2.54 |
| Psychoeducation - Phase I | Change in Parent-reported Depressive Symptoms and Global Functioning. | PROMIS Parent Proxy - General Health | 0.88 score on a scale | Standard Deviation 2.59 |
| Psychoeducation - Phase I | Change in Parent-reported Depressive Symptoms and Global Functioning. | MFQ-SF | -4.88 score on a scale | Standard Deviation 3.6 |
| Limbix Spark - Phase II | Change in Parent-reported Depressive Symptoms and Global Functioning. | MFQ-SF | -4.83 score on a scale | Standard Deviation 4.31 |
| Limbix Spark - Phase II | Change in Parent-reported Depressive Symptoms and Global Functioning. | PROMIS Parent Proxy - General Health | 1.21 score on a scale | Standard Deviation 3.23 |
| Psychoeducation/Control Extension - Phase II | Change in Parent-reported Depressive Symptoms and Global Functioning. | MFQ-SF | -2.85 score on a scale | Standard Deviation 4.14 |
| Psychoeducation/Control Extension - Phase II | Change in Parent-reported Depressive Symptoms and Global Functioning. | PROMIS Parent Proxy - General Health | 1.04 score on a scale | Standard Deviation 2.47 |
Comparison: 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.p-value: 0.33ANOVA
Comparison: 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.p-value: 0.9ANOVA
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.
Time frame: From Baseline to Post Treatment (Week 5)
Population: Participants who completed post-program questionnaires. Phase II participants were included if they had a baseline PHQ-8 score ≥ 10.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Number of Potentially Eligible Participants | Change in Participant-rated Anxiety Symptoms and Global Functioning | GAD-7 | -2.87 score on a scale | Standard Deviation 4.67 |
| Number of Potentially Eligible Participants | Change in Participant-rated Anxiety Symptoms and Global Functioning | PROMIS - General Health | 1.13 score on a scale | Standard Deviation 3.64 |
| Psychoeducation - Phase I | Change in Participant-rated Anxiety Symptoms and Global Functioning | PROMIS - General Health | -0.14 score on a scale | Standard Deviation 2.69 |
| Psychoeducation - Phase I | Change in Participant-rated Anxiety Symptoms and Global Functioning | GAD-7 | -2.29 score on a scale | Standard Deviation 3.94 |
| Limbix Spark - Phase II | Change in Participant-rated Anxiety Symptoms and Global Functioning | GAD-7 | -3.21 score on a scale | Standard Deviation 4.54 |
| Limbix Spark - Phase II | Change in Participant-rated Anxiety Symptoms and Global Functioning | PROMIS - General Health | 1.35 score on a scale | Standard Deviation 3.41 |
| Psychoeducation/Control Extension - Phase II | Change in Participant-rated Anxiety Symptoms and Global Functioning | GAD-7 | -1.45 score on a scale | Standard Deviation 3.33 |
| Psychoeducation/Control Extension - Phase II | Change in Participant-rated Anxiety Symptoms and Global Functioning | PROMIS - General Health | -0.35 score on a scale | Standard Deviation 1.85 |
Comparison: 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.p-value: 0.23ANOVA
Comparison: 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.p-value: 0.11ANOVA
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.
Time frame: From Baseline to Post Treatment (Week 5)
Population: Participants with baseline PHQ-8 ≥ 10.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Number of Potentially Eligible Participants | Number of Participants in Remission | 13 Participants |
| Psychoeducation - Phase I | Number of Participants in Remission | 7 Participants |
| Limbix Spark - Phase II | Number of Participants in Remission | 11 Participants |
| Psychoeducation/Control Extension - Phase II | Number of Participants in Remission | 2 Participants |
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.
Time frame: From Baseline to Post Treatment (Week 5)
Population: Only Phase I participants were included in this Outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Number of Potentially Eligible Participants | Phase I - Change in Depression Symptoms | -3.89 score on a scale | Standard Deviation 5.29 |
| Psychoeducation - Phase I | Phase I - Change in Depression Symptoms | -3.34 score on a scale | Standard Deviation 5.14 |
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.
Time frame: From Baseline to Post Treatment (Week 5)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Number of Potentially Eligible Participants | Phase II - Safety | Adverse Events | 4 Participants |
| Number of Potentially Eligible Participants | Phase II - Safety | Unanticipated Adverse Device Effects | 0 Participants |
| Number of Potentially Eligible Participants | Phase II - Safety | Adverse Device Effects | 0 Participants |
| Number of Potentially Eligible Participants | Phase II - Safety | None | 76 Participants |
| Number of Potentially Eligible Participants | Phase II - Safety | Serious Adverse Events | 0 Participants |
| Psychoeducation - Phase I | Phase II - Safety | None | 78 Participants |
| Psychoeducation - Phase I | Phase II - Safety | Adverse Events | 2 Participants |
| Psychoeducation - Phase I | Phase II - Safety | Serious Adverse Events | 0 Participants |
| Psychoeducation - Phase I | Phase II - Safety | Adverse Device Effects | 0 Participants |
| Psychoeducation - Phase I | Phase II - Safety | Unanticipated Adverse Device Effects | 0 Participants |