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

• 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: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information

• First Submitted Date: September 20, 2005
• First Posted Date: September 22, 2005
• Results First Submitted Date: September 9, 2014
• Results First Posted Date: December 17, 2014
• Last Update Posted Date: April 24, 2015
• Study Start Date: March 2006
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 20, 2005): Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks.

Current Secondary Outcome Measures (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 (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: Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Depressive Disorder
• Depression

Intervention

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

• 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 *

• Mohr DC, Vella L, Hart S, Heckman T, Simon G. The Effect of Telephone-Administered Psychotherapy on Symptoms of Depression and Attrition: A Meta-Analysis. Clin Psychol (New York). 2008;15(3):243-253.
• Mohr DC, Carmody T, Erickson L, Jin L, Leader J. Telephone-administered cognitive behavioral therapy for veterans served by community-based outpatient clinics. J Consult Clin Psychol. 2011 Apr;79(2):261-5. doi: 10.1037/a0022395.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2009): 85
• Original Enrollment (submitted: September 20, 2005): 154
• Actual Study Completion Date: April 2010
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00223652
• Other Study ID Numbers: IIR 03-069
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
• Study Sponsor: US Department of Veterans Affairs
• Collaborators: Not Provided

Investigators

• 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