Major DepressionNCT02891564
ESTIA: Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults
A study testing Band Together in people with Major Depression, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- Band Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2019to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Washington Department of Psychiatry and Behavioral Sciences
Seattle, Washington, 98195
Weill-Cornell Medical Center
White Plains, New York, 10605
About this study
Official title: 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.
Read the 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).
- Conditions
- Major Depression
- Being tested
- Band Together, Control Mobile 3D video game
- Keywords
- therapeutic video games, mobile interventions
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Band TogetherBehavioural
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.
Control Mobile 3D video gameOther
expectancy-matched control game
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (R 33) | Placebo comparator | a mobile 3D video game to be used as placebo. Receives: Other: Control Mobile 3D video game |
| Intervention Arm (R 33) | Experimental | 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. Receives: Behavioral: Band Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
CCN Function (Circuitry and Performance)
- Assess pre-post treatment change in activation (percent signal Δ) during the stroop/flanker test
Measured: 8 weeks
CCN Function (Self-Report- Disability)
- Pre-post self-report assessment of disability via WHO Disability Assessment Scale (36-item)
Measured: 8 weeks
CCN Function (Self-Report- Depressive Symptoms)
- Pre-post self-report assessment of depressive symptoms via Hamilton Depression Rating Scale (24-item)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start2 Jan 2019
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pat Arean, University of Washington
- Investigators
- Patricia A Arean, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891564
- Sponsor's protocol ID
- STUDY00001809
- Status last verified
- Dec 2022
- First submitted
- 1 Sep 2016
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make de-identified data available to all parties interested.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults
- ClinicalTrials.gov ID
- NCT02891564
- Acronym / sponsor ID
- STUDY00001809
- Conditions
- Major Depression
- Keywords
- therapeutic video games, mobile interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, University of California, San Francisco
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Control Arm (R 33) | Placebo comparator | Other: Control Mobile 3D video gamea mobile 3D video game to be used as placebo. |
| Intervention Arm (R 33) | Experimental | Behavioral: Band Togethera 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Band Togethera 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. | Behavioural | Intervention Arm (R 33) |
| Control Mobile 3D video gameexpectancy-matched control game | Other | Control Arm (R 33) |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Yes. We will make de-identified data available to all parties interested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A Arean, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Band Together in people with Major Depression, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CCN Function (Circuitry and Performance) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.