Automated Telephone System to Improve Treatment Adherence in People With Depression

July 24, 2013 updated by: Boston Medical Center

Telecom System to Improve Adherence to Antidepressants

This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to test the efficacy of a computerized telephone system called TLC (Telephone-Linked Care) in helping subjects adhere to their antidepressant medication regimens.

Study Type

Interventional

Enrollment

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three
  • Prescribed at least one antidepressant medication
  • Access to a telephone with touch-tone service
  • Speak and understand conversational English

Exclusion Criteria:

  • Current significant alcohol or drug abuse
  • Clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder
  • Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), or other neurodegenerative diseases
  • Alzheimer's disease and other dementia
  • Cancer, undergoing radiation therapy or chemotherapy
  • Suffering from Renal disease or on dialysis
  • Immunologic disorder (rheumatoid arthritis, systemic lupus erythematosus [SLE], etc.)
  • HIV
  • Terminal illness
  • Homeless
  • Legally blind
  • Planning to leave the geographic area during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antidepressant medication adherence
Time Frame: Measured monthly for 4 months
Measured monthly for 4 months
Adherence to scheduled psychiatry clinic visits
Time Frame: Measured monthly for 4 months
Measured monthly for 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression status, measured by self-administered depression inventory scale
Time Frame: Measured at baseline and at 4 month follow-up
Measured at baseline and at 4 month follow-up
General health status, measured by self-rating health survey
Time Frame: Measured at baseline and at 4 month follow-up
Measured at baseline and at 4 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Director: Ramesh Farzanfar, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

July 25, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH063937 (U.S. NIH Grant/Contract)
  • DAHBR HB-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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