Overview

This trial is active, not recruiting.

Condition depression
Treatment computerized decision support system
Sponsor IRCCS Centro San Giovanni di Dio Fatebenefratelli
Start date November 2012
End date January 2016
Trial size 120 participants
Trial identifier NCT01701791, RF-2010-2316063

Summary

Background: In Italy, several recent studies found that a large percentage of patients attending Primary Care (PC) clinics meet criteria for at least one common mental disorder, as they show high rates of depression, anxiety, and co-morbid anxiety and depression. These patients may experience significant functional impairment and suffer from unexplained somatic symptoms, and often remain undetected and untreated. Consistent evidence for the effectiveness of organized care programs for depression, by improving quality of care and treatment adherence, is now available. Fundamental elements of these programs include algorithms to prompt the proper and timely implementation of evidence-based treatments, structured outcome assessment and systematic outreach. Telemedicine tools may represent a valuable strategy for improving depression outcomes in PC.

Aims: 1.To develop and employ computer-based assessment to more accurately and timely detect patient depression in PC settings; 2.To evaluate the feasibility and effectiveness of a care support program developed in conjunction with the PC-based assessment for patients suffering from depression, as based on two main objectives: 2a.To support GP decisions with treatment algorithms and improve the quality of GP and mental health service collaboration; 2b.To improve patient compliance and treatment adherence by using appropriate telecommunication tools and technologically advanced tools to conduct systematic routine assessment. Although much of this system will be computer-based, live telephonic and in-person contacts will also be included as needed.

Study Design: The study is a randomized controlled trial, involving four PC group clinics (GCs) located in two areas of Northern Italy. Two PC clinics will use the experimental protocol; the other two will serve as controls.

The study will compare two different conditions:

- Group 1 (experimental): GPs will use a Computer Decision Support System with treatment algorithms and advice and supervision from a consultant psychiatrist. Patients will receive reminders via mobile texting or automatic mobile (or landline) phone calls to improve adherence to the treatment prescribed.

- Group 2 (control): GPs will provide TAU, will make their own decisions and will therefore not use the CDSS. Patients will not receive any reminders. All enrolled patients will be administered and will fill in the IDS-SR at baseline, 3 and 6-months: the IDS-SR score will be used as a primary endpoint.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
GPs will use a CDSS with treatment algorithms, supervision from a consultant psychiatrist, and despatch to patients of reminders via mobile texting or automatic mobile (or landline) phone calls to improve adherence to the treatment prescribed.
computerized decision support system
(No Intervention)
GPs will provide TAU, will make their own decisions and will therefore not use the CDSS. Patients will not receive any reminders.

Primary Outcomes

Measure
Proportion of patients reaching remission
time frame: 6 months

Secondary Outcomes

Measure
Number of GP appointments actually attended during follow-up
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Patients aged 18-65 years - PHQ-9 score of >or=14 at baseline - IDS-SR score of >or=26 at baseline - No filling of antidepressant medication prescription for 270 prior days - Illiteracy or the lack of working telephone to receive reminders. Exclusion Criteria: - Current diagnosis of alcohol or substance dependence - History of Bipolar Disorder determined by a baseline Composite International Diagnostic Interview (CIDI) screening scale of lifetime mania/hypomania - Any current prescription for mood stabilizer or antipsychotic medication - Female with positive pregnancy test - General medical conditions which contraindicate antidepressant medications - Clinical status requiring inpatient or day hospital treatment.

Additional Information

Official title The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care
Principal investigator Matteo Balestrieri, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by IRCCS Centro San Giovanni di Dio Fatebenefratelli.