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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014