Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012974
First received: March 14, 2001
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to examine the efficacy of telephone-administered cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by community-based outpatient clinics (CBOCs) in the Veteran�s Integrated Service Network (VISN) 21, which serves rural areas in Northern California


Condition Intervention Phase
Heart Failure
Beta-blocker Treatment
Behavioral: GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)
Procedure: Provider education, computer reminders, nurse case management
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Innovative Strategies for Implementing New CHF Guideline Recommendations

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maintenance of treatment gains at 6 month follow-up (week 48). [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2005
Study Completion Date: May 2007
Arms Assigned Interventions
Arm 1 Behavioral: GTelephone-administered Cognitive-Behavioral Therapy (T-CBT) Procedure: Provider education, computer reminders, nurse case management

Detailed Description:

More that 20% of patients in primary care have depressive disorders. While primary care is the principal venue for treatment for depression, fewer than 25% of depressed patients receive adequate treatment for their depression. These outcomes can be worse when there are barriers to treatment such as living in a rural area. Several studies have found that given a choice, about two-thirds of depressed primary care patients prefer psychotherapy or counseling over antidepressant medication.

This is a controlled, randomized trial in which subjects meeting criteria for major depressive disorder (MDD) from primary care settings in VISN 21 including CBOCs will be randomly assigned to one of two conditions: 1) a 16-session manualized telephone administered cognitive behavioral therapy (T-CBT) delivered over 24 weeks or 2) a treatment-as-usual (TAU) condition. Telephone-administered cognitive behavioral therapy (T-CBT) is an intervention aimed at improving coping skills and social functioning. It is divided into two phases: 1) an initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and 2) a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains. T-CBT, administered by doctoral level psychologists, will be compared to a treatment-as-usual (TAU) condition that controls for the natural course of depression during the course of treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have chronic heart failure, systolic left ventricular dysfunction (ejection fraction less than or equal to 45%), not be receiving beta-blockers, and not have contraindications to beta-blockers.

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012974

Locations
United States, California
VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
Investigators
Principal Investigator: Barry M Massie, MD VA Medical Center, San Francisco
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012974     History of Changes
Other Study ID Numbers: CHI 99-063
Study First Received: March 14, 2001
Last Updated: April 14, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014