Games to Overcome Late Life Depression

Study Overview
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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.

Official Title
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Games to Overcome Late Life Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Problem Solving Therapy
* Behavioral: Evolution
* Behavioral: Words


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Problem Solving Therapy<br>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. | Behavioral: Problem Solving Therapy<br>* 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.<br>* Other names: PST;|
| Experimental: Evolution<br>Evolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network. | Behavioral: Evolution<br>* 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<br>* Other names: Project: Evolution;|
| Placebo Comparator: Words<br>Words is a challenging crosswords type of game that will serve as the placebo comparator to Evo. | Behavioral: Words<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression over time | Hamilton Depression Rating Scale | weeks 0, 4, 8, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression; mood; cognitive training