Measuring Quality of Decisions About Treatment of Depression

NCT01152307 | Completed Results

• 1 other identifier: CSR-DQ1-002
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Depressive disorder; Decision Making; Decision Aids; Decision Quality Instrument

Outcome Measures

Primary Outcomes (1)

• 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%).

  2 weeks, on average

Secondary Outcomes (1)

• Value Concordance

  2 weeks, on average

Study Arms (2)

Decision Aid

EXPERIMENTAL

Group receiving the decision aid (DVD/booklet)

Behavioral: DVD/Booklet: Coping with Symptoms of Depression

Control

NO INTERVENTION

Group not receiving the decision aid (DVD/booklet)

Interventions

DVD/Booklet: Coping with Symptoms of Depression BEHAVIORAL

DVD and booklet that provides information about treatment choices for depression symptoms

Also known as: Decision aids, Shared decision making programs

Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• University of Massachusetts, Boston: lead
• Foundation for Informed Medical Decision Making: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Center for Survey Research - University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

Related Publications (1)

• 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.

  PMID: 34445969 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

Those who answered fewer than half of the knowledge questions do not have a total knowledge score (primary outcome).

Results Point of Contact

• Title: Dr. Karen Sepucha
• Organization: Massachusetts General Hospital

ksepucha@partners.org

617-724-3350

Study Officials

• Patricia M Gallagher, PhD

  University of Massachusetts, Boston

  STUDY DIRECTOR

• Karen R Sepucha, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 20, 2012
• Results First Posted: August 20, 2012

Record last verified: 2012-07

Locations

US (1)