A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): Limbix Spark; Psychoeducation
Intervention type(s): Device; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescence; Digital Therapeutic; Cognitive Behavioral Therapy; Behavioral Activation