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Games to Overcome Late Life Depression (GOLD)

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ClinicalTrials.gov Identifier: NCT02229188
Recruitment Status : Active, not recruiting
First Posted : September 1, 2014
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Pat Arean, University of Washington

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Problem Solving Therapy Behavioral: Evolution Behavioral: Words Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Games to Overcome Late Life Depression
Actual Study Start Date : December 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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.
Other Name: PST
Experimental: Evolution
Evolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network.
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
Other Names:
  • Neuroracer
  • Evo
  • Project: Evolution
Placebo Comparator: Words
Words is a challenging crosswords type of game that will serve as the placebo comparator to Evo.
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



Primary Outcome Measures :
  1. Change in depression over time [ Time Frame: weeks 0, 4, 8, 24 ]
    Hamilton Depression Rating Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229188


Locations
United States, Washington
University of Washington Department of Psychiatry and Behavioral Sciences
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Patricia Arean, PhD University of Washington

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pat Arean, Professor, Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT02229188     History of Changes
Other Study ID Numbers: STUDY00001751
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by Pat Arean, University of Washington:
Depression; mood; cognitive training

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders