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

Phase 1

Completed

• Conditions: Beta-blocker Treatment; Heart Failure
• Interventions: Behavioral: GTelephone-administered Cognitive-Behavioral Therapy (T-CBT); Procedure: Provider education, computer reminders, nurse case management

• Registration Number: NCT00012974
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2001-03-14
• Study First Submitted QC: 2001-03-15
• Study First Posted: 2001-03-16
• Study Start: 2005-11
• Status Verified: 2005-12
• Study Completion: 2007-05
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 1	Provider education, computer reminders, nurse case management	-
Arm 1	GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)	-

Primary Outcome Measures

Name	Time	Method
Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Maintenance of treatment gains at 6 month follow-up (week 48).

Trial Locations

Locations (2)

San Francisco VA Medical Center, San Francisco, CA; 🇺🇸 San Francisco, California, United States

VA Northern California Health Care System, Mather, CA; 🇺🇸 Sacramento, California, United States