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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
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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
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 May 16, 2013