Clinical trial NCT02922556: Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
Official title: Piloting a Novel, Mobile Cognitive Training Tool for Patients With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change scores for depressive symptoms using Beck Depression Scale (BDI)
timeFrame: 3 months and 6 months
measure: Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
timeFrame: 3 months and 6 months
measure: Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)
timeFrame: 3 months and 6 months
measure: Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
References: