Mood Patient Powered Research Network (MoodNetwork) | NCT02453438

Studies
Mood Patient Powered Research Network (MoodNetwork)

NCT02453438

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Sep 6, 2019Actual

Enrollment

5,716Actual

Phase

Not provided

Conditions

Mood Disorders
Bipolar Disorder
Major Depressive Disorder
Depression

Interventions

Patient Reported Outcomes

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Mar 2019Actual

Completion Date

Mar 2019Actual

First Submitted Date

May 5, 2015

First Submission Date that Met QC Criteria

May 22, 2015

First Posted Date

May 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2019

Last Update Posted Date

Sep 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew A. Nierenberg, MD, Director, Bipolar Clinic and Research Program, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is to improve the nation's capacity to conduct comparative effectiveness research that reflects questions of greatest importance to patients and other stakeholders. A robust data infrastructure will be built that, in phase one, allows participants to contribute data, including those from participant questionnaires, visualize their own health information in intuitive and helpful ways, and share their aggregated de-identified health information within and outside of the Network.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,716Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient Reported Outcomes	Other	Patient reported outcomes will be collected using a variety of questionnaires that assess mood symptoms.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Reported Outcomes Working Group Items Questionnaire		average of 3 years
Composite International Diagnostic Interview Mania Questionnaire		average of 3 years
Mini International Neuropsychiatric Interview Depression		average of 3 years
Quick Inventory of Depressive Symptoms Self Report		average of 3 years
Altman Self Rated Mania Scale		average of 3 years
WHO-five well-being index (WHO-5)		average of 3 years
Depression and Bipolar Support Alliance Wellness Tracker Questionnaire		average of 3 years
Experience of Care and Health Outcomes Questionnaire		average of 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

English speaking
Valid email address
Self-identify as having a mood disorder

Exclusion Criteria:

Under 18 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

English speaking individuals over 18 years of age who self-identify as having a mood disorder.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew A Nierenberg, M.D.	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital Bipolar Clinic and Research Program		Boston	Massachusetts	02134	United States

Condition Browse Module

MeSH Terms

ID	Term
D019964	Mood Disorders
D001714	Bipolar Disorder
D003865	Depressive Disorder, Major
D003863	Depression

Ancestor Terms

ID	Term
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D003866	Depressive Disorder
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000071066	Patient Reported Outcome Measures

Ancestor Terms

ID	Term
D019538	Health Care Surveys
D011795	Surveys and Questionnaires
D003625	Data Collection
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided