Games to Overcome Late Life Depression

Major Depressive Disorder Clinical Trial

— GOLD  

Official title:

Games to Overcome Late Life Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229188
• Other study ID #: STUDY00001751
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
United States	University of Washington Department of Psychiatry and Behavioral Sciences	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression over time	Hamilton Depression Rating Scale	weeks 0, 4, 8, 24

External Links

•   BRIGHTEN Center