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

Major Depressive Disorder Clinical Trial

— MDD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922556
• Other study ID #: PSC-1008-2015
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 21, 2019

Study information

• Verified date: June 2019
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Other:
• Computerized Plasticity-Based Adaptive Cognitive Training

• Commercially available computerized training

Locations

Country	Name	City	State
United States	Posit Science Corporation	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Posit Science Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores for depressive symptoms using Beck Depression Scale (BDI)		3 months and 6 months
Primary	Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)		3 months and 6 months
Primary	Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)		3 months and 6 months
Primary	Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)		3 months and 6 months