An interventional study of Limbix Spark and Psychoeducation in Depression, sponsored by Limbix Health, Inc.. Completed at 1 site in United States. Open to participants aged 13 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-18.
Sponsored by Limbix Health, Inc. · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 227 is above the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →Limbix Health, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A 5 week CBT-based intervention
Device: Limbix Spark
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
Other: Psychoeducation
The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
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
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)
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"
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)
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)
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)
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)
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)
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)
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
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)
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)
| Milestone | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation - Phase II | Control Extension - Phase II |
|---|---|---|---|---|---|
| Started | 35 | 25 | 0 | 0 | 0 |
| Completed | 31 | 20 | 0 | 0 | 0 |
| Not completed | 4 | 5 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 4 | 0 | 0 | 0 |
| Withdrew: Dropped for missing two consecutive weekly safety check-ins. | 2 | 1 | 0 | 0 | 0 |
| Milestone | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation - Phase II | Control Extension - Phase II |
|---|---|---|---|---|---|
| Started | 0 | 0 | 80 | 80 | 0 |
| Met phq-8 threshold (baseline >/= 10) | 0 | 0 | 63 | 58 | 0 |
| Completed | 0 | 0 | 54 | 67 | 0 |
| Not completed | 0 | 0 | 26 | 13 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 16 | 8 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Dropped for missing two consecutive weekly safety check-ins. | 0 | 0 | 8 | 5 | 0 |
| Milestone | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation - Phase II | Control Extension - Phase II |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 66 |
| Completed | 0 | 0 | 0 | 0 | 54 |
| Not completed | 0 | 0 | 0 | 0 | 12 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 6 |
| Withdrew: Dropped for missing two consecutive weekly safety check-ins. | 0 | 0 | 0 | 0 | 6 |
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.
| Participants | Number of Potentially Eligible Participants |
|---|---|
| Limbix Spark - Phase I | 35 |
| Psychoeducation - Phase I | 25 |
Descriptive report of willingness to participate and program adherence. Phase I participant arms are reported for this outcome.
| Participants | Limbix Spark - Phase I | Psychoeducation - Phase I |
|---|---|---|
| % of eligible participants willing to participate | 35 | 25 |
| % of enrolled participants completing all sessions by post-treatment | 8 | — |
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.
| units on a scale | Limbix Spark - Phase I | Psychoeducation - Phase I |
|---|---|---|
| Participant Reported Mood Improvement | 5.08 ± 2.54 | 1.78 ± 2.21 |
| Participant Reported Enjoyment | 6.79 ± 2.11 | 3.94 ± 2.51 |
Descriptive report of participant safety. Phase I participant arms are reported for this outcome.
| Participants | Limbix Spark - Phase I | Psychoeducation - Phase I |
|---|---|---|
| Adverse Events | 0 | 0 |
| Serious Adverse Events | 0 | 2 |
| Adverse Device Effects | 0 | 0 |
| Unanticipated Adverse Device Effects | 0 | 0 |
| None | 35 | 23 |
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.
| score on a scale | Limbix Spark - Phase II | Psychoeducation - Phase II |
|---|---|---|
| Phase II - Change in Depressive Symptoms | -5.08 (-6.72 to -3.42) | -3.51 (-5.09 to -1.93) |
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.
| score on a scale | Limbix Spark - Phase I | Psychoeducation - Phase I |
|---|---|---|
| Phase I - Change in Depression Symptoms | -3.89 ± 5.29 | -3.34 ± 5.14 |
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 | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II |
|---|---|---|---|---|
| Number of Participants in Remission | 13 | 7 | 11 | 2 |
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.
| score on a scale | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II |
|---|---|---|---|---|
| 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 |
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.
| units on a scale | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II |
|---|---|---|---|---|
| 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 |
Between-group treatment-related differences in clinical concern rates and serious clinical concerns. Phase II participant arms are reported for this outcome.
| Participants | Limbix Spark - Phase II | Psychoeducation - Phase II |
|---|---|---|
| Adverse Events | 4 | 2 |
| Serious Adverse Events | 0 | 0 |
| Adverse Device Effects | 0 | 0 |
| Unanticipated Adverse Device Effects | 0 | 0 |
| None | 76 | 78 |
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).
| app modules completed | Limbix Spark - Phase I | Limbix Spark - Phase II |
|---|---|---|
| App Engagement and Adherence | 2.74 ± 1.69 | 3.17 ± 1.82 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Limbix Spark - Phase I | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Psychoeducation - Phase I | 0/25 (0%) | 2/25 (8%) | 0/25 (0%) |
| Limbix Spark - Phase II | 0/80 (0%) | 0/80 (0%) | 4/80 (5%) |
| Psychoeducation - Phase II | 0/80 (0%) | 0/80 (0%) | 2/80 (2.5%) |
| Event | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation - Phase II |
|---|---|---|---|---|
| Hospitalized for a suicide attemptPsychiatric disorders | 0/35 | 1/25 | 0/80 | 0/80 |
| Hospitalized for "low mood"Psychiatric disorders | 0/35 | 1/25 | 0/80 | 0/80 |
| Event | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation - Phase II |
|---|---|---|---|---|
| Clinical DeteriorationPsychiatric disorders | 0/35 | 0/25 | 1/80 | 2/80 |
| Suicidal IdeationPsychiatric disorders | 0/35 | 0/25 | 2/80 | 0/80 |
| Non-Suicidal Self-Injury IdeationPsychiatric disorders | 0/35 | 0/25 | 1/80 | 0/80 |
| Age, Categorical(Participants) | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II | Total |
|---|---|---|---|---|---|
| <=18 years | 18 | 17 | 33 | 35 | 103 |
| Between 18 and 65 years | 17 | 8 | 30 | 23 | 78 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II | Total |
|---|---|---|---|---|---|
| Mean | 18 ± 2.36 | 17 ± 2.57 | 17.06 ± 2.49 | 16.46 ± 2.43 | 16.78 ± 2.47 |
| Sex/Gender, Customized(Participants) | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II | Total |
|---|---|---|---|---|---|
| Participant Reported Gender — Female | 28 | 19 | 42 | 39 | 128 |
| Participant Reported Gender — Male | 6 | 5 | 16 | 10 | 37 |
| Participant Reported Gender — Non-Binary | 1 | 1 | 5 | 9 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 6 | 4 | 11 | 8 | 29 |
| Not Hispanic or Latino | 29 | 21 | 46 | 47 | 143 |
| Unknown or Not Reported | 0 | 0 | 6 | 3 | 9 |
| Race (NIH/OMB)(Participants) | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 | 2 | 4 |
| Asian | 7 | 4 | 4 | 0 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 3 | 2 | 10 |
| White | 20 | 17 | 47 | 45 | 129 |
| More than one race | 3 | 1 | 8 | 8 | 20 |
| Unknown or Not Reported | 2 | 0 | 0 | 1 | 3 |
| Region of Enrollment(participants) | Limbix Spark - Phase I | Psychoeducation - Phase I | Limbix Spark - Phase II | Psychoeducation/Control Extension - Phase II | Total |
|---|---|---|---|---|---|
| United States | 35 | 25 | 63 | 58 | 121 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Limbix Health, Inc.