NCT02922556

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

3.8 years

First QC Date

July 13, 2016

Last Update Submit

June 21, 2019

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

  • Change scores for depressive symptoms using Beck Depression Scale (BDI)

    3 months and 6 months

  • Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)

    3 months and 6 months

  • Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12)

    3 months and 6 months

  • Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9)

    3 months and 6 months

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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

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

Interventions

Computerized Plasticity-Based Adaptive Cognitive TrainingOTHER
Also known as: Moodify
Experimental Treatment
Commercially available computerized trainingOTHER
Also known as: Games
Active Comparator

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94111, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Games, Experimental

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

October 4, 2016

Study Start

September 1, 2015

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations

US(1)