A Closed-loop Assessment and Treatment Platform for Unipolar Depression and Anxiety
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Specific Aim 1: Finalize development of the closed-loop strategy in the MMT application.

      Specific Aim 2: Evaluate the acceptability and feasibility of the MMT application with the
      target population to prepare for a large-scale efficacy trial.
    

Detailed description: 
      Specific Aim 1: Investigators have recently constructed a beta version of the MMT
      application, comprised of the multi-modal assessment modules, several treatment modules and
      an initial version of the closed-loop algorithm to control treatment delivery. Utilizing the
      extensive experience in developing mobile assessment and treatment tools at Posit Science
      Corporation, the investigators will employ an iterative development process incorporating
      feedback from users (focus groups of patients with mood disorders), clinicians and scientists
      (project consultants) to achieve the following development goals: (1) Finalize MMT's
      closed-loop algorithm to incorporate all assessment modules and expand the existing triage
      approach; (2) Expand cognitive behavioral therapy (CBT) functions within the app; and (3)
      Expand in-app bi-directional communication feature between the clinician and user. At the
      completion of Specific Aim 1, the investigators will have a mobile app suitable for
      evaluation in a feasibility trial (Specific Aim 2).

      Specific Aim 2: The investigators will conduct a single arm, open label feasibility field
      trial with 40 participants that meet criteria for Major Depressive Disorder (MDD).
      Participants will be asked to engage with the experimental cognitive treatment and spend up
      to six weeks engaged in 15 hours of cognitive training as an adjunct to their standard
      clinical treatment. The experimental cognitive treatment will be deployed as dictated by the
      closed loop predictive algorithm, with all patient data continuously accessible for remote
      monitoring by the attending clinicians, research staff and Principal Investigator at
      University of Minnesota, and research staff and Sponsor PI at Posit Science Corporation.
      Participants will be re-evaluated every two weeks during treatment use, and again at the
      expected time of completion of training, at 6 weeks, to evaluate changes in cognitive
      function. Participants will then stop using their assigned program for 6 weeks, and return
      for a follow-up assessment to evaluate the endurance of changes in cognitive function in the
      absence of further program use.
    

Intervention name(s): Mobile-device, plasticity-based adaptive cognitive treatment
Intervention type(s): Other
Intervention description(s): This study employs a mobile-device delivered treatment program. Participants will be asked to use the assigned treatment program for approximately 30 minutes per session, up to seven sessions per week, over 6 weeks (42 total sessions).
Other intervention name(s): MMT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment