Games to Overcome Late Life Depression

NCT ID: NCT02229188

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Problem Solving Therapy

Problem Solving Therapy is an evidence-based behavioral treatment for late life depression proven effective with different geriatric groups including ambulatory; medically ill; older adults with executive dysfunctions; and more recently, low-income, disabled older adults.

Group Type ACTIVE_COMPARATOR

Problem Solving Therapy

Intervention Type 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.

Evolution

Evolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network.

Group Type EXPERIMENTAL

Evolution

Intervention Type 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

Words

Words is a challenging crosswords type of game that will serve as the placebo comparator to Evo.

Group Type PLACEBO_COMPARATOR

Words

Intervention Type 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

Interventions

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Problem Solving Therapy

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.

Intervention Type BEHAVIORAL

Evolution

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

Intervention Type BEHAVIORAL

Words

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

Intervention Type BEHAVIORAL

Other Intervention Names

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PST Neuroracer Evo Project: Evolution

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. History of psychosis, mania, or currently using or abusing illicit drugs or alcohol
2. Diagnosis of dementia
3. Taking cognitive enhancers
4. Change in or newly began taking psychiatric medication within the last 6 months
5. Pacemaker
6. Metal in the body that cannot be removed
7. Color blind
8. Movement disorder that prevents participation -
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Pat Arean

Professor, Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Arean, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington Department of Psychiatry and Behavioral Sciences

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Anguera JA, Gunning FM, Arean PA. Improving late life depression and cognitive control through the use of therapeutic video game technology: A proof-of-concept randomized trial. Depress Anxiety. 2017 Jun;34(6):508-517. doi: 10.1002/da.22588. Epub 2017 Jan 3.

Reference Type DERIVED
PMID: 28052513 (View on PubMed)

Other Identifiers

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STUDY00001751

Identifier Type: -

Identifier Source: org_study_id

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