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

March 14, 2001
April 14, 2014
November 2005
Not Provided
Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00012974 on ClinicalTrials.gov Archive Site
Maintenance of treatment gains at 6 month follow-up (week 48). [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas
Innovative Strategies for Implementing New CHF Guideline Recommendations

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Beta-blocker Treatment
  • Behavioral: GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)
  • Procedure: Provider education, computer reminders, nurse case management
Arm 1
Interventions:
  • Behavioral: GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)
  • Procedure: Provider education, computer reminders, nurse case management

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2007
Not Provided

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:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012974
CHI 99-063
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Barry M Massie, MD VA Medical Center, San Francisco
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP