Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922556
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Posit Science Corporation

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Commercially available computerized training Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
Study Start Date : September 2015
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : June 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Name: Moodify

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
Other Name: Games




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922556


Locations
Layout table for location information
United States, California
Posit Science Corporation
San Francisco, California, United States, 94111
Sponsors and Collaborators
Posit Science Corporation

Layout table for additonal information
Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT02922556    
Other Study ID Numbers: PSC-1008-2015
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms