Major Depressive Disorder (MDD)

Effectiveness of Physicians' Education, Implementation and Follow up of Current Recommendations Regarding Screening for Major Depressive Disorder in High Risk Patients on Improving the Under-Recognition Rates of Depression in Primary Care

The purpose of this study is to assess the effectiveness of systematic screening for depression in high-risk patient participants in everyday clinical practice. Systematic screening for depression in high-risk patients is recommended to be included as a usual practice but its effectiveness in this context remains controversial. In this study, 35 primary care physicians (PCPs) in Spain were assigned to intervention (receive one day training in depression screening guidelines and use guidelines for six months) and 34 PCPs were assigned to a control group (manage depression in the usual way for six months). There were a total of 525 patient participants with MDD.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Intervention; Behavioral: Control

• Study Type: Observational
• Enrollment (Actual): 525

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary Care Physicians are given the intervention of education to utilize on screened and consented patient participants under the PCP care.

Description

Inclusion Criteria:

• PCP Participants: PCPs informed of the study design and who agreed to be randomized to the intervention or control group
• Patient Participants: Aged 18 years or older who provide a written consent for the collection and use of their clinical data

Exclusion Criteria:

• PCP Participants: If they already follow the recommendations on screening or were planning to do so. If they will be absent from their practice for a significant period during the study, or if they do not usually manage depression
• PCP Participants: Those who were not able to understand the aims of the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months	Behavioral: Intervention; PCP receives one day training in depression screening guidelines and uses guidelines for six months
Control; Control group PCP manages depression in the usual way for six months	Behavioral: Control; PCP manages depression in the usual way for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks	24 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks	24 Weeks
Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks	Baseline, 24 Weeks
Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks	Baseline, 24 Weeks
Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks	Baseline, 24 Weeks
Mean Duration of Depressive Episodes in Patient Participants	24 Weeks
Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants	24 Weeks
Sheehan Disability Scale (SDS) Score in Patient Participants	24 Weeks
Mean Duration of Sick Leave Due to Depression in Patient Participants	24 Weeks
Percentage of Patient Participants with Sick Leave Due to Depression	24 Weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Romera I, Montejo AL, Aragones E, Arbesu JA, Iglesias-Garcia C, Lopez S, Lozano JA, Pamulapati S, Yruretagoyena B, Gilaberte I. Systematic depression screening in high-risk patients attending primary care: a pragmatic cluster-randomized trial. BMC Psychiatry. 2013 Mar 13;13:83. doi: 10.1186/1471-244X-13-83.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Estimate): August 10, 2012
• Last Update Submitted That Met QC Criteria: August 8, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 13487; H6U-XM-S007 (Other Identifier: Eli Lilly and Company)