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OpenTrials
Completed

NCT Number: NCT02922556

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Posit Science Corporation

San Francisco, California, 94111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

Other names: Moodify

Commercially available computerized training

Other

Other names: Games

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

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Registry information

Acronym: MDD

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2016
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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