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Automated Telephone System to Improve Treatment Adherence in People With Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00136240
First Posted: August 29, 2005
Last Update Posted: July 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Boston Medical Center
  Purpose
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.

Condition Intervention
Depression Behavioral: Computer Assisted Education for Behavior Change

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Telecom System to Improve Adherence to Antidepressants

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Antidepressant medication adherence [ Time Frame: Measured monthly for 4 months ]
  • Adherence to scheduled psychiatry clinic visits [ Time Frame: Measured monthly for 4 months ]

Secondary Outcome Measures:
  • Depression status, measured by self-administered depression inventory scale [ Time Frame: 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 ]

Estimated Enrollment: 144
Study Start Date: April 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136240


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
National Institute of Mental Health (NIMH)
Investigators
Study Director: Ramesh Farzanfar Boston University
  More Information

Responsible Party: Ramesh Farzanfar
ClinicalTrials.gov Identifier: NCT00136240     History of Changes
Other Study ID Numbers: R21MH063937 ( U.S. NIH Grant/Contract )
DAHBR HB-A
First Submitted: August 25, 2005
First Posted: August 29, 2005
Last Update Posted: July 25, 2013
Last Verified: August 2008

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders