Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD) (MDD)
June 21, 2019 updated by: Posit Science Corporation
To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games).
Study Overview
Status
Completed
Conditions
Detailed Description
The study will involve a randomized, controlled, double-blind trial to assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games).
Moodify is comprised of a novel continuous performance task (CPT) to improve cognitive slowing and lethargy often present in cases of major depressive disorder.
This training method is based on an existing, validated cognitive training paradigm (tonic and phasic attention training, TAPAT1; WIRB Study No. 1126399).
Moodify will also employ two additional cognitive training modules previously validated in this and other clinical populations.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94111
- Posit Science Corporation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must 18 to 85 years or older and not pregnant
- Participants must be fluent in English
- Participants must be able to engage with computerized cognitive tasks as required in order to participate in this study.
- Normal vision (or corrected to normal vision)
- Participants must be willing to commit to the time requirements of the study as evidenced by written, informed consent.
- Participants must meet diagnostic criteria for MDD
Exclusion Criteria:
- Participants report or present a hand tremor that prevents the use of a computer mouse or keyboard
- Participants unable to perform neuropsychological evaluations
- Participants cannot comprehend or follow instructions
- Participants not capable of giving informed consent
- Participants who appear to be intoxicated or under the influence of a controlled substance
- Participants with a history of significant medical diseases or multiple neurological events of the head
- Participants with serious or unstable medical illness (e.g. cardiovascular, hepatic, renal, endocrine, neurologic disease)
- Participants with a history or current diagnosis to specific Diagnostic and Statistical Manual (DSM)-IV psychiatric illness such as (but not limited to): organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder Not Otherwise Specific, bipolar disorder, substance dependence and substance abuse
- Participants with a history of seizure disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Treatment
Computerized plasticity-based adaptive cognitive training (Moodify) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.
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Other Names:
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Active Comparator: Active Comparator
Commercially available computerized training (Games) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change scores for depressive symptoms using Beck Depression Scale (BDI)
Time Frame: 3 months and 6 months
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3 months and 6 months
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Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
Time Frame: 3 months and 6 months
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3 months and 6 months
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Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)
Time Frame: 3 months and 6 months
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3 months and 6 months
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Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)
Time Frame: 3 months and 6 months
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3 months and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
June 21, 2019
Study Completion (Actual)
June 21, 2019
Study Registration Dates
First Submitted
July 13, 2016
First Submitted That Met QC Criteria
September 30, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Actual)
June 25, 2019
Last Update Submitted That Met QC Criteria
June 21, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSC-1008-2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.