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CompletedNCT02922556MDDUpdated Jun 25, 2019

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

An interventional study of Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in Major Depressive Disorder, sponsored by Posit Science Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-25.

Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 28 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Posit Science Corporation is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • 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.

    Other: Computerized Plasticity-Based Adaptive Cognitive Training

  • 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.

    Other: Commercially available computerized training

Interventions

  • OtherComputerized Plasticity-Based Adaptive Cognitive Training

    Also known as: Moodify

  • OtherCommercially available computerized training

    Also known as: Games

06

What researchers measure

Primary outcomes

  1. Change scores for depressive symptoms using Beck Depression Scale (BDI)

    Time frame: 3 months and 6 months

  2. Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)

    Time frame: 3 months and 6 months

  3. 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

  4. Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)

    Time frame: 3 months and 6 months

07

Study locations

1 site
  • Posit Science Corporation
    San Francisco, California 94111, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02922556
Lead sponsor
Posit Science Corporation
Responsible party
Sponsor
First posted
Oct 4, 2016
Start date
Sep 2015
Primary completion
Jun 21, 2019
Completion
Jun 21, 2019
Last update
Jun 25, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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