Games to Overcome Late Life Depression
GOLD
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Dec 2013
Longer than P75 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 26, 2014
CompletedFirst Posted
Study publicly available on registry
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedSeptember 19, 2018
September 1, 2018
4.7 years
August 26, 2014
September 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in depression over time
Hamilton Depression Rating Scale
weeks 0, 4, 8, 24
Study Arms (3)
Problem Solving Therapy
ACTIVE COMPARATORProblem 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
EXPERIMENTALEvolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network.
Words
PLACEBO COMPARATORWords is a challenging crosswords type of game that will serve as the placebo comparator to Evo.
Interventions
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.
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 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington Department of Psychiatry and Behavioral Sciences
Seattle, Washington, 98105, United States
Related Publications (1)
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.
PMID: 28052513DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Arean, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Psychiatry and Behavioral Sciences
Study Record Dates
First Submitted
August 26, 2014
First Posted
September 1, 2014
Study Start
December 1, 2013
Primary Completion
August 1, 2018
Study Completion
August 31, 2018
Last Updated
September 19, 2018
Record last verified: 2018-09