Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)

Posit Science

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Commercially available computerized training

Study type: Interventional

Funder types: Industry

Identifiers

NCT02922556

PSC-1008-2015

Details and patient eligibility

About

To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for depression (Moodify) versus an active control treatment (commercially available computer games).

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

Experimental Treatment

Experimental group

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.

Treatment:

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

Active Comparator group

Description:

Commercially available computerized training (Games) requiring a total maximum of 50 treatment hours, 3-5 times weekly, 30-45 minutes each session.

Treatment:

Other: Commercially available computerized training