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

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00012974
Collaborator
(none)
60
2
1
17.9
30
1.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)
  • Procedure: Provider education, computer reminders, nurse case management
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Innovative Strategies for Implementing New CHF Guideline Recommendations
Study Start Date :
Nov 1, 2005
Actual Study Completion Date :
May 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Behavioral: GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)

Procedure: Provider education, computer reminders, nurse case management

Outcome Measures

Primary Outcome Measures

  1. Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks []

Secondary Outcome Measures

  1. Maintenance of treatment gains at 6 month follow-up (week 48). []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 VA Northern California Health Care System, Mather, CA Sacramento California United States 95655
2 San Francisco VA Medical Center, San Francisco, CA San Francisco California United States 94121

Sponsors and Collaborators

  • US Department of Veterans Affairs

Investigators

  • Principal Investigator: Barry M Massie, MD, San Francisco VA Medical Center, San Francisco, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
US Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012974
Other Study ID Numbers:
  • CHI 99-063
First Posted:
Mar 16, 2001
Last Update Posted:
Apr 7, 2015
Last Verified:
Dec 1, 2005
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2015