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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00223652
First received: September 20, 2005
Last updated: April 6, 2015
Last verified: August 2014
  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 and (VISN) 12, which serves rural areas surrounding the Hines, IL VA Hospital.

Condition Intervention Phase
Depressive Disorder Depression Behavioral: Telephone cognitive behavioral therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tele-Mental Health Intervention to Improve Depression Outcomes in Community Based Outpatient Clinics (CBOCs)

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 85
Study Start Date: March 2006
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - Telephone CBT
Telephone cognitive behavioral therapy
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.
No Intervention: Arm 2 - Treatment as Usual
Treatment as usual control.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223652

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David C. Mohr, PhD Edward Hines Jr. VA Hospital, Hines, IL
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00223652     History of Changes
Other Study ID Numbers: IIR 03-069
Study First Received: September 20, 2005
Results First Received: September 9, 2014
Last Updated: April 6, 2015

Keywords provided by VA Office of Research and Development:
Cognitive-Behavioral Therapy
Telephone psychotherapy
Clinical Trial
Primary Care Clinic
Treatment for Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 19, 2017