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.
Device: Limbix Spark
The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
Other: Psychoeducation
The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
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
Limbix Health, Inc.
San Francisco, California, United States