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Games to Overcome Late Life Depression (GOLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229188
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Pat Arean, University of Washington

Tracking Information
First Submitted Date  ICMJE August 26, 2014
First Posted Date  ICMJE September 1, 2014
Last Update Posted Date September 19, 2018
Actual Study Start Date  ICMJE December 2013
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2014)
Change in depression over time [ Time Frame: weeks 0, 4, 8, 24 ]
Hamilton Depression Rating Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Games to Overcome Late Life Depression
Official Title  ICMJE Games to Overcome Late Life Depression
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Problem Solving Therapy
  • Experimental: Evolution
    Evolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network.
    Intervention: Behavioral: Evolution
  • Placebo Comparator: Words
    Words is a challenging crosswords type of game that will serve as the placebo comparator to Evo.
    Intervention: Behavioral: Words
Publications * Anguera JA, Gunning FM, Areán 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2014)
40
Actual Study Completion Date  ICMJE August 31, 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229188
Other Study ID Numbers  ICMJE STUDY00001751
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pat Arean, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patricia Arean, PhD University of Washington
PRS Account University of Washington
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP