ESTIA: Computerized Intervention Targeting Cognitive Control Deficits in Depressed Adults

NCT02891564 | Completed DMC

• 1 other identifier: STUDY00001809
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depression

Keywords

therapeutic video games, mobile interventions

Outcome Measures

Primary Outcomes (3)

• CCN Function (Circuitry and Performance)

  \- Assess pre-post treatment change in activation (percent signal Δ) during the stroop/flanker test

  8 weeks

• CCN Function (Self-Report- Disability)

  \- Pre-post self-report assessment of disability via WHO Disability Assessment Scale (36-item)

  8 weeks

• CCN Function (Self-Report- Depressive Symptoms)

  \- Pre-post self-report assessment of depressive symptoms via Hamilton Depression Rating Scale (24-item)

  8 weeks

Study Arms (2)

Control Arm (R 33)

PLACEBO COMPARATOR

a mobile 3D video game to be used as placebo.

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.

Behavioral: Band Together

Interventions

Band Together BEHAVIORAL

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.

Intervention Arm (R 33)

Control Mobile 3D video game OTHER

expectancy-matched control game

Control Arm (R 33)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of Washington: lead
• Weill Medical College of Cornell University: collaborator
• University of California, San Francisco: collaborator

Study Sites (2)

Weill-Cornell Medical Center

White Plains, New York, 10605, United States

Location

University of Washington Department of Psychiatry and Behavioral Sciences

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Patricia A Arean, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 7, 2016
• Study Start: January 2, 2019
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)