ESTIA: Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02891564|
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Behavioral: Band Together Other: Control Mobile 3D video game||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Randomized Control Trial|
|Masking:||None (Open Label)|
|Official Title:||Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults|
|Actual Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||September 2021|
Placebo Comparator: Control Arm (R 33)
a mobile 3D video game to be used as placebo.
Other: Control Mobile 3D video game
expectancy-matched control 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.
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.
- 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)
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
|Contact: Brittany Mosser, MSWemail@example.com|
|United States, New York|
|Weill-Cornell Medical Center||Recruiting|
|White Plains, New York, United States, 10605|
|Contact: Faith Gunning, PhD 914-997-8643 firstname.lastname@example.org|
|United States, Washington|
|University of Washington Department of Psychiatry and Behavioral Sciences||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Brittany Mosser, MSW 206-543-3350 email@example.com|
|Contact: Jaden Duffy, BA 206-616-4947 firstname.lastname@example.org|
|Principal Investigator: Patricia A Arean, PhD|
|Principal Investigator: Faith Gunning, PhD|
|Principal Investigator: Joaquin Anguera, PhD|
|Principal Investigator:||Patricia A Arean, PhD||University of Washington|