An interventional study of Active Intervention in Depressive Symptoms, Depression and Depressive Disorder, sponsored by Limbix Health, Inc.. Completed at 1 site in United States. Open to participants aged 13 Years to 21 Years. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by Limbix Health, Inc. · Not applicable, Interventional, and Treatment
The goal of this study is to test whether an investigational mobile app can be a helpful treatment option for adolescents with symptoms of depression. Adolescents aged 13 to 21 with depression symptoms can be part of this study if eligible.
Eligible participants will be randomly assigned to one of two groups: one group will receive the mobile app intervention in addition to their usual care and the other group will simply continue their usual care for symptoms of depression. Both groups will have 5 weeks to use a study app, and will complete assessments during the intervention period, at post-intervention, and at one month follow-up.
The primary aim of the proposed research is to evaluate the effectiveness of a self-guided, cognitive behavioral therapy (CBT)-based mobile app + assessment-enhanced Usual Care (eUC) compared to eUC alone as an intervention for adolescents with symptoms of depression who are under the supervision of a licensed healthcare provider.
The sample size for this study is 220 subjects. Sample size calculation is based on primary outcome patient health questionnaire (PHQ-8) at post-intervention (5 weeks). Six PHQ-8 measurements will be collected from each subject (baseline and weekly during the 5-week intervention period). Using a two-sample t-test approach, assuming a two-tailed alpha set at 0.05, a total of 200 participants (100 in each study arm) will give us 80% power to detect a moderate effect size of at least d=0.4. Given an anticipated 10% rate of attrition, we aim to enroll 220 total participants in the study.
A 50% female sample will be targeted. Earlier recruitment efforts within the study demographic have resulted in majority female samples, consistent with prevalence rates within the study population. As such, recruitment efforts will be undertaken to ensure representation of male participants. Recruitment efforts will be taken to ensure adequate representation of underrepresented racial and ethnic minority groups.
Children between the ages of 13-17 will be included in this research as the program to be evaluated is specifically designed as an intervention for adolescents with symptoms of depression. Assent will be obtained from all children under 18 for study enrollment unless legally emancipated or financially independent in accordance with CA state regulations and regulations of the state in which the minor resides.
Study staff will monitor participants' symptom deterioration and questionnaire data for safety.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 223 is above the median of 84 across 6,720 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.
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Exclusion Criteria:
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
Device: Active Intervention
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
Depressive Symptom Severity at Post-intervention
Measured by the Patient Health Questionnaire (PHQ-8), an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.
Time frame: Post-intervention (5 week timepoint)
Intervention Response at Post-intervention
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Intervention response is defined as a 50% reduction in PHQ-8 score from baseline.
Time frame: Change from baseline to post-intervention (5 weeks)
Remission at Post-intervention
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Remission is defined as a PHQ-8 score less than 5 at post-intervention.
Time frame: Post-intervention (5 week timepoint)
Clinically-meaningful Reduction in Severity at Post-intervention
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Clinically-meaningful reduction is defined as a ≥5 point reduction in PHQ-8 score from baseline.
Time frame: Change from baseline to post-intervention (5 weeks)
| Milestone | Active Intervention | Usual Care |
|---|---|---|
| Started | 111 | 112 |
| Completed | 96 | 98 |
| Not completed | 15 | 14 |
Measured by the Patient Health Questionnaire (PHQ-8), an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.
| units on a scale | Active Intervention | Usual Care |
|---|---|---|
| Depressive Symptom Severity at Post-intervention | 8.39 ± 0.38 | 11.03 ± 0.37 |
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Intervention response is defined as a 50% reduction in PHQ-8 score from baseline.
| percentage of participants | Active Intervention | Usual Care |
|---|---|---|
| Intervention Response (Yes) | 31.7 (22.5 to 40.8) | 11.6 (5.2 to 18.0) |
| Intervention Response (No) | 68.3 (59.2 to 77.5) | 88.4 (82.0 to 94.8) |
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Remission is defined as a PHQ-8 score less than 5 at post-intervention.
| percentage of participants | Active Intervention | Usual Care |
|---|---|---|
| Remission at Post-intervention | 24.9 (16.4 to 33.4) | 9.4 (3.9 to 15.0) |
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Clinically-meaningful reduction is defined as a ≥5 point reduction in PHQ-8 score from baseline.
| percentage of participants | Active Intervention | Usual Care |
|---|---|---|
| Clinically-meaningful Reduction in Severity at Post-intervention | 40.5 (30.9 to 50.1) | 15.8 (8.9 to 22.7) |
Collected over Through study completion, up to 11 weeks after randomization. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Intervention | 0/111 (0%) | 2/111 (1.8%) | 0/111 (0%) |
| Usual Care | 0/112 (0%) | 1/112 (0.9%) | 0/112 (0%) |
| Event | Active Intervention | Usual Care |
|---|---|---|
| HospitalizationPsychiatric disorders | 2/111 | 0/112 |
| Victim of violenceSocial circumstances | 0/111 | 1/112 |
| Age, Categorical(Participants) | Active Intervention | Usual Care | Total |
|---|---|---|---|
| <=18 years | 54 | 56 | 110 |
| Between 18 and 65 years | 57 | 56 | 113 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 17.3 ± 2.6 | 17.2 ± 2.7 | 17.3 ± 2.6 |
| Sex/Gender, Customized(participants) | Active Intervention | Usual Care | Total |
|---|---|---|---|
| Gender Identity : Girl/Woman | 61 | 65 | 126 |
| Gender Identity : Boy/Man | 35 | 33 | 68 |
| Gender Identity : Non-binary | 13 | 16 | 29 |
| Gender Identity : Transgender | 13 | 10 | 23 |
| Gender Identity : Intersex | 1 | 0 | 1 |
| Gender Identity : Other | 8 | 4 | 12 |
| Gender Identity : I prefer not to say | 2 | 3 | 5 |
| Sex: Female, Male(Participants) | Active Intervention | Usual Care | Total |
|---|---|---|---|
| Female | 82 | 81 | 163 |
| Male | 28 | 30 | 58 |
| Ethnicity (NIH/OMB)(Participants) | Active Intervention | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 15 | 30 |
| Not Hispanic or Latino | 87 | 89 | 176 |
| Unknown or Not Reported | 9 | 8 | 17 |
| Race (NIH/OMB)(Participants) | Active Intervention | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 7 | 4 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 8 | 19 |
| White | 77 | 86 | 163 |
| More than one race | 11 | 11 | 22 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Patient Health Questionnaire-8 (PHQ-8)(units on a scale) | Active Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 12.14 ± 4.28 | 12.59 ± 4.24 | 12.37 ± 4.26 |
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Limbix Health, Inc.