Self-guided Treatment for Adolescents Navigating Depression
Condition: Depressive Symptoms; Depression; Depressive Disorder; Depressive Episode
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Active Intervention
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Mental Health; Adolescents; Depression; Adolescent Mental Health