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Automated Telephone System to Improve Treatment Adherence in People With Depression

This study has been completed.
Sponsor:
Collaborator:
Boston Medical Center
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00136240
First received: August 25, 2005
Last updated: August 19, 2008
Last verified: August 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Telecom System to Improve Adherence to Antidepressants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Antidepressant medication adherence [ Time Frame: Measured monthly for 4 months ] [ Designated as safety issue: No ]
  • Adherence to scheduled psychiatry clinic visits [ Time Frame: Measured monthly for 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression status, measured by self-administered depression inventory scale [ Time Frame: Measured at baseline and at 4 month follow-up ] [ Designated as safety issue: No ]
  • General health status, measured by self-rating health survey [ Time Frame: Measured at baseline and at 4 month follow-up ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136240

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

No publications provided

Responsible Party: Ramesh Farzanfar
ClinicalTrials.gov Identifier: NCT00136240     History of Changes
Other Study ID Numbers: R21 MH63937, DAHBR HB-A
Study First Received: August 25, 2005
Last Updated: August 19, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 21, 2013