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Games to Overcome Late Life Depression (GOLD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Pat Arean, University of Washington
ClinicalTrials.gov Identifier:
NCT02229188
First received: August 26, 2014
Last updated: October 11, 2016
Last verified: October 2016
  Purpose
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 Intervention
Major Depressive Disorder
Behavioral: Problem Solving Therapy
Behavioral: Evolution
Behavioral: Words

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Games to Overcome Late Life Depression

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in depression over time [ Time Frame: weeks 0, 4, 8, 24 ] [ Designated as safety issue: Yes ]
    Hamilton Depression Rating Scale


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Genders 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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02229188

Contacts
Contact: Kathy Ringwood, MSW 206.221.8568 ringwood@uw.edu

Locations
United States, Washington
University of Washington Department of Psychiatry and Behavioral Sciences Recruiting
Seattle, Washington, United States, 98105
Contact: Kathy Ringwood, MSW    206-221-8568    ringwood@uw.edu   
Contact: Patricia Arean, PhD    206.221.8692    cadyms@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Patricia Arean, PhD University of Washington
  More Information

Additional Information:
Responsible Party: Pat Arean, Professor, Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT02229188     History of Changes
Other Study ID Numbers: 49440-EG 
Study First Received: August 26, 2014
Last Updated: October 11, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on January 14, 2017