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

Sponsor
Posit Science Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02922556
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
45.6
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Computerized Plasticity-Based Adaptive Cognitive Training
  • Other: Commercially available computerized training
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Sep 1, 2015
Actual Primary Completion Date :
Jun 21, 2019
Actual Study Completion Date :
Jun 21, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • Games

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change scores for depressive symptoms using Beck Depression Scale (BDI) [3 months and 6 months]

    2. Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7) [3 months and 6 months]

    3. Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12) [3 months and 6 months]

    4. Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9) [3 months and 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Posit Science Corporation San Francisco California United States 94111

    Sponsors and Collaborators

    • Posit Science Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Posit Science Corporation
    ClinicalTrials.gov Identifier:
    NCT02922556
    Other Study ID Numbers:
    • PSC-1008-2015
    First Posted:
    Oct 4, 2016
    Last Update Posted:
    Jun 25, 2019
    Last Verified:
    Jun 1, 2019
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major

    Study Results

    No Results Posted as of Jun 25, 2019