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Games to Overcome Late Life Depression (GOLD)

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Problem Solving Therapy

Evolution

Words

About this trial

This is an interventional health services research trial for Major Depressive Disorder focused on measuring Depression; mood; cognitive training

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

University of Washington Department of Psychiatry and Behavioral Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Problem Solving Therapy

Evolution

Words

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Change in depression over time

Hamilton Depression Rating Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02229188

First Posted

August 26, 2014

Last Updated

September 18, 2018

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT02229188

Brief Title

Games to Overcome Late Life Depression

Acronym

GOLD

Official Title

Games to Overcome Late Life Depression

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

December 2013 (Actual)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Depression; mood; cognitive training

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Problem Solving Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Evolution

Arm Type

Experimental

Arm Description

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

Arm Title

Words

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Problem Solving Therapy

Other Intervention Name(s)

PST

Intervention Description

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

Intervention Name(s)

Evolution

Other Intervention Name(s)

Neuroracer, Evo, Project: Evolution

Intervention Description

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

Intervention Name(s)

Words

Intervention Description

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 Outcome Measure Information:

Title

Change in depression over time

Description

Hamilton Depression Rating Scale

Time Frame

weeks 0, 4, 8, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia Arean, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington Department of Psychiatry and Behavioral Sciences

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28052513

Citation

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.

Results Reference

derived

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Games to Overcome Late Life Depression

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