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

This study is not yet open for patient recruitment.
Verified by Department of Veterans Affairs September 2005

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223652

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
Depressive Disorder
Depression
 Behavior: Telephone-administered Cognitive-Behavioral Therapy (T-CBT)
Phase I
Phase II

MedlinePlus related topics:  Depression;   Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Official Title: Tele-Mental Health Intervention to Improve Depression Outcomes in CBOCs

Further Study Details: 
Primary Outcomes: Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks.
Secondary Outcomes: Maintenance of treatment gains at 6 month follow-up (week 48).
Expected Total Enrollment:  154

Study start: November 2005;  Expected completion: November 2009
Last follow-up: May 2009

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 above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Has a DSM-IV diagnosis of Major Depressive Disorder as assessed using the SCID
  • Has a telephone
  • Able to speak and read English
  • At least 18 years of age
  • Able to give informed consent

Exclusion Criteria:

  • Has a hearing, voice or visual impairment that would prevent participation in T-CBT
  • Meets criteria for dementia
  • Is diagnosed with Psychotic Disorder, Bipolar Disorder, current PTSD or substance abuse
  • Is currently receiving psychotherapy or planning to receive psychotherapy suring the 24-week treatment phase of the study
  • Has a history of suicide attempts.
  • Has initiated treatment with an antidepressant in the past 2 months prior to enrollment.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00223652

Paul J Westcoat       Paul.Westcoat@va.gov

California
      San Francisco, San Francisco,  California,  94121,  United States
Lena Inoue
Claudine Catledge, MA  (415) 221-4810  Ext. 4954    claudine.catledge@va.gov 
David C. Mohr, PhD,  Principal Investigator

Study chairs or principal investigators

David C. Mohr, PhD,  Principal Investigator,  San Francisco   

More Information

Study ID Numbers:  IIR 03-069
Last Updated:  September 26, 2005
Record first received:  September 20, 2005
ClinicalTrials.gov Identifier:  NCT00223652
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27



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