A Mobile and Virtual Reality Intervention for Adolescent Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depression, the most common mental health disorder among adolescents, is a critical health
      problem within the US. In this study, the feasibility, acceptability, and preliminary
      efficacy of Limbix Spark, a cognitive behavioral therapy (CBT)- based mobile app + virtual
      reality (VR) program for helping adolescents live well with depression will be investigated.
      This program is specifically designed around behavioral activation theory, the idea that
      completing activities that make a patient feel pleasure or provide a sense of mastery are
      effective in reducing symptoms of depression. The program involves the use of both VR and a
      mobile app that include CBT components like psychological assessments, psychoeducation, and
      skills training. 30 participants aged 12-21 years old with mild to severe depressive symptoms
      and smartphone access will be enrolled in this study. The primary efficacy outcome measures
      will be depressive symptoms with anxiety symptoms, functional outcomes, and dimensional
      scales of positive and negative affect and behavioral activation serving as secondary outcome
      measures. Qualitative and quantitative feedback on the use of the VR + mobile app (ease of
      use, comfort, willingness to use again) will be assessed using questionnaires. Engagement and
      adherence to the program will be assessed by assessing VR and app usage.
    

Detailed description: 
      Depression, the most common mental health disorder among adolescents, is a major public
      health concern with significant personal, societal, and economic burdens, particularly as
      incidence rates are increasing. Effective care for adolescent depression is limited due to
      lack of access to care, increasingly long waitlists, stigma surrounding mental health, and
      ineffectiveness of pharmaceutical options. There is an urgent need for accessible,
      cost-effective, and evidence-based treatment options for adolescents with depression.

      The development of effective digital health programs for adolescents is a key strategy to
      reduce the personal, familiar and societal burden of depression. Such programs provide an
      innovative way to deliver resources in a cost-effective, accessible fashion.
      Cognitive-behavioral therapy (CBT) is effective in the prevention and treatment of depression
      in children and adolescents. Digital forms of CBT have also been shown to be efficacious in
      the treatment of anxiety and depressive symptoms in youth, however. adherence to such
      programs in clinical trials and particularly in real world evidence evaluations is low.
      Virtual reality (VR) holds promise as a way to enhance adherence to and the efficacy of
      digital CBT for depression.

      To address the need for effective, accessible, and engaging treatments for adolescent
      depression, the objective of this project is to evaluate the feasibility, acceptability, and
      preliminary evidence of efficacy of Limbix Spark: a 5 week CBT-based mobile + VR self-guided
      program. Limbix Spark is specifically designed to implement behavioral activation, a CBT
      skill, which involves completing self-monitored activities that provide a sense of pleasure
      or mastery in order to reduce depressive symptoms and improve functional outcomes. VR allows
      adolescents to complete such activities in virtual environments as a potential stepping stone
      to engaging in similar experiences in the real world.

      30 participants aged 12-21 years old with mild to severe depressive symptoms and with smart
      phone access will be enrolled. During a baseline visit, participants or participants' legal
      guardians, will be asked to provide written informed consent and potential participants under
      18 will be asked to provide written assent after study procedures are explained and any
      questions are answered by study staff in accordance with good clinical practice (GCP) and
      human subjects research guidelines.

      After consent, all eligible participants will be assigned to complete the 5-week Limbix Spark
      program. Participants and their legal guardian if under 18 will first complete baseline
      assessments, including the Patient Health Questionnaire (PHQ-8) Generalized Anxiety Disorder
      scale (GAD-7), the Positive and Negative Affective Schedule (PANAS-C), the Behavioral
      Activation for Depression Scale-Short Form (BADS-SF), 20-item Short Form Survey (SF-20), Mood
      and Feelings Questionnaire Short Parent version (MFQ-PS). Participants will then receive VR
      equipment, and receive an initial orientation to the Limbix Spark program. Program
      orientation will include training on how to set up and use the VR headset and how to download
      and use the mobile app.

      The 5 modules in the Limbix Spark program are meant to be completed weekly, however,
      participants will be allowed to progress through the program at their own pace. Each module
      contains VR and mobile app components and is expected to take no more than 60 minutes to
      complete, with no more than approximately 25 min per module of VR content. Modules do not
      need to be completed in a single session and can be completed over the course of several
      days. During the program, weekly PHQ-8 assessments will be completed within the mobile app.

      At the post-intervention site visit, participants and their legal guardian if under 18 will
      complete post-program assessments, including the PHQ-8, GAD-7, PANAS-C, MFQ-PS, SF-20, and
      BADS-SF, as well as a questionnaire about their thoughts and experiences with the Spark
      program. Participants will also complete a qualitative interview to further understand their
      experience with the program.

      One month after the post-intervention site visit, participants will be sent a 1-month follow
      up questionnaires via email, including the PHQ-8, GAD-7, PANAS-C, MFQ-PS, SF-20, and BADS-SF,
      as well as a questionnaire about their thoughts and experiences with the Spark program.
    

Intervention name(s): Limbix Spark
Intervention type(s): Other
Intervention description(s): 5-week, self-guided mobile + VR CBT-based program for adolescent depression
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adolescence; Cognitive Behavioral Therapy; Virtual Reality; Depression; Behavioral Activation