Major Depressive DisorderGOLDNCT02229188
Games to Overcome Late Life Depression
A study testing Problem Solving Therapy, Evolution and Words in people with Major Depressive Disorder, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Problem Solving Therapy, Evolution and Words
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Department of Psychiatry and Behavioral Sciences
Seattle, Washington, 98105
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Problem Solving Therapy, Evolution, Words
- Keywords
- Depression; mood; cognitive training
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
Also called PST
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.
EvolutionBehavioural
Also called Neuroracer, Evo, Project: 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
WordsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Problem Solving Therapy | Active comparator | 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. Receives: Behavioral: Problem Solving Therapy |
| Evolution | Experimental | Evolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network. Receives: Behavioral: Evolution |
| Words | Placebo comparator | Words is a challenging crosswords type of game that will serve as the placebo comparator to Evo. Receives: Behavioral: Words |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression over time
Hamilton Depression Rating Scale
Measured: weeks 0, 4, 8, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pat Arean, University of Washington
- Investigators
- Patricia Arean, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229188
- Sponsor's protocol ID
- STUDY00001751
- Acronym
- GOLD
- Status last verified
- Sep 2018
- First submitted
- 26 Aug 2014
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Anguera JA, Gunning FM, Arean 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.
PubMed 28052513
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Games to Overcome Late Life Depression
- ClinicalTrials.gov ID
- NCT02229188
- Acronym / sponsor ID
- GOLD / STUDY00001751
- Conditions
- Major Depressive Disorder
- Keywords
- Depression; mood; cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Therapy | Active comparator | Behavioral: Problem Solving TherapyProblem 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. |
| Evolution | Experimental | Behavioral: EvolutionEvolution is a plasticity intervention in the form of a video driving game that targets the cognitive conflict network. |
| Words | Placebo comparator | Behavioral: WordsWords is a challenging crosswords type of game that will serve as the placebo comparator to Evo. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving TherapyAlso: PSTProblem 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. | Behavioural | Problem Solving Therapy |
| EvolutionAlso: Neuroracer, Evo, Project: EvolutionEvo 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 | Behavioural | Evolution |
| WordsWords 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 | Behavioural | Words |
Primary outcome
Change in depression over time
Time frame: weeks 0, 4, 8, 24
Hamilton Depression Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Derived from this study: PubMed 28052513Anguera JA, Gunning FM, Arean 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Arean, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy, Evolution and Words in people with Major Depressive Disorder, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression over time (time frame: weeks 0, 4, 8, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.