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

NCT ID: NCT02922556

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-06-21

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type: OTHER

Active Comparator

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

Group Type: ACTIVE_COMPARATOR

Commercially available computerized training

Intervention Type: OTHER

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type: OTHER

Commercially available computerized training

Intervention Type: OTHER

Other Intervention Names

Moodify; Games

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Posit Science Corporation

San Francisco, California, United States

Countries

United States

Other Identifiers

PSC-1008-2015

Identifier Type: -

Identifier Source: org_study_id