Measuring Quality of Decisions About Treatment of Depression

This study has been completed.
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Information provided by (Responsible Party):
Carol Cosenza, University of Massachusetts, Boston
ClinicalTrials.gov Identifier:
NCT01152307
First received: June 22, 2010
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals and treatment choices.


Condition Intervention
Depression
Behavioral: DVD/Booklet: Coping with Symptoms of Depression

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Measuring Quality of Decisions About Treatment of Depression

Further study details as provided by University of Massachusetts, Boston:

Primary Outcome Measures:
  • Depression Knowledge [ Time Frame: 2 weeks, on average ] [ Designated as safety issue: No ]
    Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).


Secondary Outcome Measures:
  • Value Concordance [ Time Frame: 2 weeks, on average ] [ Designated as safety issue: No ]
    Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs


Enrollment: 405
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decision Aid
Group receiving the decision aid (DVD/booklet)
Behavioral: DVD/Booklet: Coping with Symptoms of Depression
DVD and booklet that provides information about treatment choices for depression symptoms
Other Names:
  • Decision aids
  • Shared decision making programs
No Intervention: Control
Group not receiving the decision aid (DVD/booklet)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18+
  • In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling)

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152307

Locations
United States, Massachusetts
Center for Survey Research - University of Massachusetts Boston
Boston, Massachusetts, United States, 02125
Sponsors and Collaborators
University of Massachusetts, Boston
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Investigators
Study Director: Patricia M Gallagher, PhD Center for Survey Research/University of Massachusetts Boston
Principal Investigator: Karen R Sepucha, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Carol Cosenza, Project Manager, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT01152307     History of Changes
Other Study ID Numbers: CSR-DQ1-002
Study First Received: June 22, 2010
Results First Received: June 12, 2012
Last Updated: July 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Boston:
Depression
Depressive disorder
Decision Making
Decision Aids
Decision Quality Instrument

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014