A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19
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|ClinicalTrials.gov Identifier: NCT04524598|
Recruitment Status : Active, not recruiting
First Posted : August 24, 2020
Last Update Posted : August 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Depression||Device: Limbix Spark Other: Psychoeducation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||227 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Limbix Spark: A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19|
|Actual Study Start Date :||July 20, 2020|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Limbix Spark
A 5 week CBT-based intervention
Device: Limbix Spark
The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
Active Comparator: Psychoeducation
5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention
The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
- Change in depressive symptoms [ Time Frame: Change from Baseline to Post treatment (5 weeks) ]Change in depressive symptoms measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression).
- Change in anxiety symptoms [ Time Frame: Change from Baseline to Post treatment (5 weeks) ]Change in anxiety symptoms measured by the Generalized Anxiety Disorder (GAD-7) scale (min: 0; max: 21, with higher score indicating more severe anxiety).
- Change in parent report of child depressive symptoms [ Time Frame: Change from Baseline to Post treatment (5 weeks) ]Change in parent report of child depressive symptoms measured by the Mood and Feelings Questionnaire (MFQ) (min: 0; max: 26, with higher score indicating more severe depression)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524598
|United States, California|
|Limbix Health, Inc.|
|San Francisco, California, United States, 94104|
|Principal Investigator:||Jessica Lake, PhD||Director of Research|
|Principal Investigator:||Aarthi Padmanabhan, Phd||Research Director|