NCT02453438

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,716

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

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

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

May 5, 2015

Last Update Submit

September 5, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

Interventions

Patient reported outcomes will be collected using a variety of questionnaires that assess mood symptoms.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Bipolar Clinic and Research Program

Boston, Massachusetts, 02134, United States

Location

MeSH Terms

Conditions

Mood DisordersBipolar DisorderDepressive Disorder, MajorDepression

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Mental DisordersBipolar and Related DisordersDepressive DisorderBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Andrew A Nierenberg, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Bipolar Clinic and Research Program

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 25, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations