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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223652
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 17, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE September 20, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE September 9, 2014
Results First Posted Date  ICMJE December 17, 2014
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE March 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • Change in Severity of Depression Using Hamilton Depression Rating Scale [ Time Frame: Baseline, 12 weeks, 20 weeks ]
    Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
  • Change in Severity of Depression Using the Patient Health Questionnaire-9 [ Time Frame: Baseline, Week 12, Week 20 ]
    Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score ranges from 0-27, higher values indicate more severe depression.
  • Number of Participants Meeting Criteria for Major Depressive Disorder [ Time Frame: Baseline to week 12, and week 20 ]
    Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • Maintenance of Treatment Effect [ Time Frame: 6 month follow-up (week 44) ]
    Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
  • Maintenance of Treatment Effect [ Time Frame: 6-month post treatment follow-up ]
    6-month post treatment follow-up on outcome measure of the Patient Health Questionnaire-9 (PHQ-9). Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 score ranges from 0-27, higher values indicate more severe depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.
  • Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up [ Time Frame: 6-month follow up at week 44 post treatment ]
    Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
Maintenance of treatment gains at 6 month follow-up (week 48).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas
Official Title  ICMJE Tele-Mental Health Intervention to Improve Depression Outcomes in Community Based Outpatient Clinics (CBOCs)
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 and (VISN) 12, which serves rural areas surrounding the Hines, IL VA Hospital.
Detailed Description

More than 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 20 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder
  • Depression
Intervention  ICMJE Behavioral: Telephone cognitive behavioral therapy
An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.
Study Arms  ICMJE
  • Experimental: Arm 1 - Telephone CBT
    Telephone cognitive behavioral therapy
    Intervention: Behavioral: Telephone cognitive behavioral therapy
  • No Intervention: Arm 2 - Treatment as Usual
    Treatment as usual control.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2009)
85
Original Enrollment  ICMJE
 (submitted: September 20, 2005)
154
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has a DSM-IV diagnosis of Major Depressive Disorder as assessed using the MINI
  • Has a telephone
  • Able to speak and read English
  • At least 18 years of age
  • Able to give informed consent
  • Must be registered at a VA community-based, outpatient clinic (CBOC) at VA Eureka or VA Ukiah or VA Santa Rosa, or VA Manteno, or VA Elgin, or VA La Salle

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, substance abuse with clinical consensus, or current severe PTSD.
  • Is currently receiving psychotherapy or planning to receive psychotherapy during the 20-week treatment phase of the study
  • Has a history of suicide attempts or is at high risk for suicide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00223652
Other Study ID Numbers  ICMJE IIR 03-069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David C. Mohr, PhD Edward Hines Jr. VA Hospital, Hines, IL
PRS Account VA Office of Research and Development
Verification Date August 2014

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