Clinical trial NCT00223652: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Depression
Keywords: Cognitive-Behavioral Therapy
Telephone psychotherapy
Clinical Trial
Primary Care Clinic
Treatment for Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-09-22
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Severity of Depression Using Hamilton Depression Rating Scale
timeFrame: Baseline, 12 weeks, 20 weeks
measure: Change in Severity of Depression Using the Patient Health Questionnaire-9
timeFrame: Baseline, Week 12, Week 20
measure: Number of Participants Meeting Criteria for Major Depressive Disorder
timeFrame: Baseline to week 12, and week 20
Secondary outcomes:
measure: Maintenance of Treatment Effect
timeFrame: 6 month follow-up (week 44)
measure: Maintenance of Treatment Effect
timeFrame: 6-month post treatment follow-up
measure: Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up
timeFrame: 6-month follow up at week 44 post treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: David C. Mohr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1468-2850.2008.00134.x.
citation: 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.