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OpenTrials
Completed

NCT Number: NCT02229188

Games to Overcome Late Life Depression

This is a pilot study divided into two phases. IN phase 1 (completed) participants will be randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now recruiting), participants will be randomized to Evo, PST, and a different cognitive training program called Words. Words is similar to Evo in that it is an adaptive training program and includes case management. IN both studies participants will be assessed for clinical and functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Department of Psychiatry and Behavioral Sciences

Seattle, Washington, 98105, United States

About this study

Evo is a computer game that targets parts of the brain (i.e. the cognitive control network) that we think may be associated with depressive symptoms. This study is exploratory and will inform future hypotheses the research team will test in subsequent research.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 60-80 years of age
  • Meets criteria for Major Depressive Disorder
  • Hamilton Depression Rating Scale (HDRS) of 20 or greater
  • Mini Mental State Exam score of 24 or greater
  • Can speak and read English
  • Able to physically participate in the research protocol (e.g.: is not suffering from a terminal or highly disabling illness)
  • Can participate in MRI scans
  • Able to provide written informed consent

Exclusion criteria

  • History of psychosis, mania, or currently using or abusing illicit drugs or alcohol
  • Diagnosis of dementia
  • Taking cognitive enhancers
  • Change in or newly began taking psychiatric medication within the last 6 months
  • Pacemaker
  • Metal in the body that cannot be removed
  • Color blind
  • Movement disorder that prevents participation -

Treatment and study plan

Problem solving therapy

Behavioral

Problem solving therapy is an evidence based behavioral intervention for late life depression. It consist of 8 weekly session of talk therapy, whereby the therapist helps the patient solve problems that are thought to be causing depressive symptoms.

Other names: PST

Evolution

Behavioral

Evo is a video game that has therapeutic elements targeting the cognitive control network. Impairment in this neural network is associated with a specific subtype of late life depression that puts people at risk for poor response to SSRIs. Evo is built from a research grade training paradigm that has shown to induce improvements in this network in healthy older adults

Other names: Neuroracer, Evo, Project: Evolution

Words

Behavioral

Words is a cognitively challenging crossword/word search type of video game that will serve as the control condition for the second phase of this project

Primary outcomes

  1. Change in depression over time

    Time frame: weeks 0, 4, 8, 24

    Hamilton Depression Rating Scale

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Acronym: GOLD

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2014
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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