Major Depressive Disorder
Conditions
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.
Interventions
Sponsors
Posit Science Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change scores for depressive symptoms using Beck Depression Scale (BDI) | 3 months and 6 months |
| Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7) | 3 months and 6 months |
| Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12) | 3 months and 6 months |
| Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9) | 3 months and 6 months |
Countries
United States
Outcome results
None listed