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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 : May 17, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Major Depression Behavioral: Project:EVO

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: We will first conduct a 2-year proof of concept study to determine if EVO can 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 are to determine if EVO will result in greater CCN engagement using three levels of analysis (circuitry, performance, self-report). At the circuitry level, we will measure CCN engagement by probing the system using task-based fMRI. We hypothesize 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 is that 66% of our sample will show 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: Should our proof of concept phase pass the Go/No-go rule, we will then conduct a 3-year pilot study to compare EVO 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 EVO in a larger randomized clinical trial will be based on whether we find (1) that EVO 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).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: mobile cognitive training
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computerized Intervention Targeting Cognitive Control Deficits in Depressed
Actual Study Start Date : January 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Project:Evo
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
Behavioral: Project:EVO
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.
Other Name: Neuroracer


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891564


Contacts
Contact: Kathy Ringwood, MSW 206-221-8569 ringwood@uw.edu
Contact: Cady Stanton, MS 206-543-5329 cadyms@uw.edu

Locations
United States, New York
Weill-Cornell Medical Center Recruiting
White Plains, New York, United States, 10605
Contact: Faith Gunning, PhD    914-997-8643    fgd2002@cornell.edu   
United States, Washington
University of Washington Department of Psychiatry and Behavioral Sciences Recruiting
Seattle, Washington, United States, 98195
Contact: Kathy Ringwood, MSW    206-221-8568    ringwood@uw.edu   
Contact: Cady Stanton, MS    206-543-5329    cadyms@uw.edu   
Principal Investigator: Patricia A Arean, PhD         
Principal Investigator: Faith Gunning, PhD         
Principal Investigator: Joaquin Anguera, PhD         
Sponsors and Collaborators
University of Washington
Weill Medical College of Cornell University
University of California, San Francisco
Investigators
Principal Investigator: Patricia A Arean, PhD University of Washington
More Information

Responsible Party: Pat Arean, Professor, Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT02891564     History of Changes
Other Study ID Numbers: STUDY00001809
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will make de-identified data available to all parties interested.

Keywords provided by Pat Arean, University of Washington:
therapeutic video games, mobile interventions

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders