Back to resultsMeasuring Quality of Decisions About Treatment of Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DVD/Booklet: Coping with Symptoms of Depression
Sponsored by
About this trial
This is an interventional health services research trial for Depression focused on measuring Depression, Depressive disorder, Decision Making, Decision Aids, Decision Quality Instrument
Eligibility 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
Sites / Locations
- Center for Survey Research - University of Massachusetts Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Decision Aid
Control
Arm Description
Group receiving the decision aid (DVD/booklet)
Group not receiving the decision aid (DVD/booklet)
Outcomes
Primary Outcome Measures
Depression Knowledge
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
Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs
Full Information
NCT ID
NCT01152307
First Posted
June 22, 2010
Last Updated
July 13, 2012
Sponsor
University of Massachusetts, Boston
Collaborators
Foundation for Informed Medical Decision Making, Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01152307
Brief Title
Measuring Quality of Decisions About Treatment of Depression
Official Title
Measuring Quality of Decisions About Treatment of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Boston
Collaborators
Foundation for Informed Medical Decision Making, Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Depressive disorder, Decision Making, Decision Aids, Decision Quality Instrument
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
Group receiving the decision aid (DVD/booklet)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group not receiving the decision aid (DVD/booklet)
Intervention Type
Behavioral
Intervention Name(s)
DVD/Booklet: Coping with Symptoms of Depression
Other Intervention Name(s)
Decision aids, Shared decision making programs
Intervention Description
DVD and booklet that provides information about treatment choices for depression symptoms
Primary Outcome Measure Information:
Title
Depression Knowledge
Description
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%).
Time Frame
2 weeks, on average
Secondary Outcome Measure Information:
Title
Value Concordance
Description
Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs
Time Frame
2 weeks, on average
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia M Gallagher, PhD
Organizational Affiliation
Center for Survey Research, University of Massachusetts, Boston
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karen R Sepucha, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Survey Research - University of Massachusetts Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34445969
Citation
Brodney S, Valentine KD, Sepucha K. Psychometric evaluation of a decision quality instrument for medication decisions for treatment of depression symptoms. BMC Med Inform Decis Mak. 2021 Aug 27;21(1):252. doi: 10.1186/s12911-021-01611-w.
Results Reference
derived
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Measuring Quality of Decisions About Treatment of Depression
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