Back to resultsPiloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD) (MDD)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-Based Adaptive Cognitive Training
Commercially available computerized training
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
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
Sites / Locations
- Posit Science Corporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Treatment
Active Comparator
Arm Description
Computerized plasticity-based adaptive cognitive training (Moodify) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.
Commercially available computerized training (Games) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.
Outcomes
Primary Outcome Measures
Change scores for depressive symptoms using Beck Depression Scale (BDI)
Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)
Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02922556
Brief Title
Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
Acronym
MDD
Official Title
Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Computerized plasticity-based adaptive cognitive training (Moodify) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Commercially available computerized training (Games) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-Based Adaptive Cognitive Training
Other Intervention Name(s)
Moodify
Intervention Type
Other
Intervention Name(s)
Commercially available computerized training
Other Intervention Name(s)
Games
Primary Outcome Measure Information:
Title
Change scores for depressive symptoms using Beck Depression Scale (BDI)
Time Frame
3 months and 6 months
Title
Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
Time Frame
3 months and 6 months
Title
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
Title
Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Posit Science Corporation
City
San Francisco
State/Province
California
ZIP/Postal Code
94111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
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