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

Depression Clinical Trial

Official title:

Tele-Mental Health Intervention to Improve Depression Outcomes in Community Based Outpatient Clinics (CBOCs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223652
• Other study ID #: IIR 03-069
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: April 6, 2015
• Start date: March 2006
• Est. completion date: April 2010

Study information

• Verified date: August 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

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.

Locations

Country	Name	City	State
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Severity of Depression Using Hamilton Depression Rating Scale	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.	Baseline, 12 weeks, 20 weeks	No
Primary	Change in Severity of Depression Using the Patient Health Questionnaire-9	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.	Baseline, Week 12, Week 20	No
Primary	Number of Participants Meeting Criteria for Major Depressive Disorder	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.	Baseline to week 12, and week 20	No
Secondary	Maintenance of Treatment Effect	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.	6 month follow-up (week 44)	No
Secondary	Maintenance of Treatment Effect	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.	6-month post treatment follow-up	No
Secondary	Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up	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.	6-month follow up at week 44 post treatment	No