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

NCT ID: NCT00223652

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-04-30

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.

Conditions

Depressive Disorder; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1 - Telephone CBT

Telephone cognitive behavioral therapy

Group Type: EXPERIMENTAL

Telephone cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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.

Arm 2 - Treatment as Usual

Treatment as usual control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David C. Mohr, PhD

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21369344 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21299274 (View on PubMed)

Other Identifiers

IIR 03-069

Identifier Type: -

Identifier Source: org_study_id