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ESTIA: Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults

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ClinicalTrials.gov Identifier: NCT02891564
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
Weill Medical College of Cornell University
University of California, San Francisco
Information provided by (Responsible Party):
Pat Arean, University of Washington

September 1, 2016
September 7, 2016
September 21, 2018
November 2018
January 2021   (Final data collection date for primary outcome measure)
  • CCN Function (Circuitry and Performance) [ Time Frame: 8 weeks ]
    - Assess pre-post treatment change in activation (percent signal Δ) during the stroop/flanker test
  • CCN Function (Self-Report- Disability) [ Time Frame: 8 weeks ]
    - Pre-post self-report assessment of disability via WHO Disability Assessment Scale (36-item)
  • CCN Function (Self-Report- Depressive Symptoms) [ Time Frame: 8 weeks ]
    - Pre-post self-report assessment of depressive symptoms via Hamilton Depression Rating Scale (24-item)
CCN engagement using task-based fMRI [ Time Frame: 4 weeks ]
we will compare baseline to 4 weeks activation and functional connectivity (FC) of anterior aspects of the CCN
Complete list of historical versions of study NCT02891564 on ClinicalTrials.gov Archive Site
Not Provided
improved performance on the Test of Variables of Attention (TOVA)4 and a delayed recognition working memory task OR decreased complaints on the Frontal Systems Behavior Scale (FRsBE) [ Time Frame: 4 weeks ]
We will compare baseline performance on the TOVA, FRsBE and the AID
Not Provided
Not Provided
 
ESTIA: Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults
Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults
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.

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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Randomized Control Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depression
  • Behavioral: Band Together
    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.
  • Other: Control Mobile 3D video game
    expectancy-matched control game
  • Placebo Comparator: Control Arm (R 33)
    a mobile 3D video game to be used as placebo.
    Intervention: Other: Control Mobile 3D video game
  • Experimental: Intervention Arm (R 33)
    a mobile 3D video game (Band Together) 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.
    Intervention: Behavioral: Band Together
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
30
September 2021
January 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • (1) Age 45 to 75; (2) unipolar, nonpsychotic major depression (by SCID, DSM-V), (3) Hamilton Depression Rating Scale > 20; (4) off antidepressants or have been on a stable dose for 12 weeks and do not intend to change dose in the next 5 weeks, (5) capacity to consent; (6) ability to participate in MRI.

Exclusion Criteria:

  • 1) Intent or plan to attempt suicide in the near future; 2) history or presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder; 3) use of psychotropic drugs or cholinesterase inhibitors other than mild doses of benzodiazepines 4) dementia or MCI (please see Human Subjects). Participants with an MMSE score falling 1 SD below the mean score for their age and education will be excluded as well.
Sexes Eligible for Study: All
45 Years to 75 Years   (Adult, Older Adult)
Yes
Contact: Kathy Ringwood, MSW 206-221-8569 ringwood@uw.edu
United States
 
 
NCT02891564
STUDY00001809
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: We will make de-identified data available to all parties interested.
Pat Arean, University of Washington
University of Washington
  • Weill Medical College of Cornell University
  • University of California, San Francisco
Principal Investigator: Patricia A Arean, PhD University of Washington
University of Washington
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP