ESTIA: Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults
Condition: Major Depression
MeSH terms: Depressive Disorder, Major
Study type: Interventional

Summary: 
      Project:EVO is a video-game based intervention that targets neural networks associated with
      cognitive control. The same networks have been implicated in poor treatment response in
      middle and older aged adults suffering from major depression. Related work has demonstrated
      that healthy older adults show significant improvement in cognitive control. In a very small
      sample of older adults suffering from depression (n=12), we found similar improvements in
      selective attention and working memory after 4 weeks of intervention, along with improvements
      in mood comparable to participants receiving an evidence-based psychotherapy. The intent of
      this proposal is to first determine if at least 2/3 of participants who use Project:EVO for
      four weeks demonstrate significant improvements in the function of these neural networks, and
      if improvements are observed, to conduct a second study to see if changes in neural network
      functions are associated with changes in mood. If we show that Project:EVO improves neural
      function and mood to a greater degree than a placebo cognitive training game, we will be in a
      position to move onto the next phase of study, which is to demonstrate the intervention's
      efficacy in a much larger sample of adults with depression.
    

Detailed description: 
      Project: EVO (or "EVO") is a mobile 3D video game that has been shown to reduce older adults'
      susceptibility to interference by augmenting sustained attention and working memory abilities
      (e.g. cognitive control) through targeted adaptive algorithms. The combination of
      peer-reviewed validity, adaptivity, and fun video game mechanics elevates the EVO platform
      beyond other at-home training tools while reducing burden associated with tedious task
      replication. We propose to study EVO as a potential intervention for the treatment of
      depression, a disorder that worsens medical outcomes, promotes disability, increases expense,
      and complicates medical care by clouding the clinical picture and undermining treatment
      adherence.

      R61 Phase (COMPLETE):

      In this first phase, we conducted a 2-year proof of concept study to determine if EVO could
      engage the cognitive control network (CCN) in 30 middle-aged and older adults with major
      depression. Primary aims for this phase of the proposed project were to determine if EVO will
      result in greater CCN engagement using three levels of analysis (circuitry, performance,
      self-report). At the circuitry level, we measured CCN engagement by probing the system using
      task-based fMRI. We hypothesized that activation and functional connectivity (FC) of anterior
      aspects of the CCN will increase from baseline to 4-weeks after treatment initiation. Our
      decision to move to the next phase of the planned study was that 66% of our sample showed
      significant increases in CCN functions at the circuitry level of analysis (CCN activation and
      FC) and at either the performance level or self-report level of analysis.

      R33 Phase (CURRENT):

      Successful proof of concept has initiated the second phase of the ESTIA study. In this phase,
      we plan to conduct a 3-year pilot study to compare "Band Together" (an EVO analog) to an
      expectancy-matched control game in terms of CCN target engagement at the circuitry
      (task-based fMRI) and behavioral levels (task performance, self-report) in 60 middle-aged and
      older adults with major depression. In addition, we well determine if changes in target
      engagement are associated with changes in mood and mood-induced disability. The decision to
      move onto development of a proposal to study the clinical efficacy of Band Together in a
      larger randomized clinical trial will be based on whether we find (1) that Band Together
      out-performs our control condition in terms of the engagement of CCN at the circuitry and
      behavioral levels (2) significant associations between changes in engagement of the CCN and
      changes in mood and (3) that the study methods are feasible to complete (sampling rate,
      retention, intervention adherence, intervention acceptability and expectancy-match for our
      control condition).
    

Intervention name(s): Band Together; Control Mobile 3D video game
Intervention type(s): Behavioral; Other
Intervention description(s): a mobile 3D video game that has been shown to reduce older adults' susceptibility to interference by augmenting sustained attention and working memory abilities (e.g. cognitive control) through targeted adaptive algorithms. This game is analogous to Project: EVO.; expectancy-matched control game
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Randomized Control Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: therapeutic video games, mobile interventions