Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression

Phase 3

Completed

Conditions: Depression

Interventions: Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)
Behavioral: Face-to-face administered CBT (FtF-CBT)

Registration Number: NCT00498706

Lead Sponsor: Northwestern University

Brief Summary: This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression.

Detailed Description: Major depressive disorder is a common and often long-lasting disorder with 12-month prevalence rates estimated to be between 6.6% and 10.3%. Although the personal and societal costs of depression are high, it is well established that depression can be effectively treated using antidepressant medication and/or forms of psychotherapy. Several studies have found that when given a choice, about two-thirds of depressed patients prefer psychotherapy or counseling over antidepressant medication. However, a variety of barriers exist to initiating and maintaining psychotherapy. Only about 20% of all patients referred for psychotherapy actually initiate treatment, and of those who do initiate treatment, nearly half drop out before completing treatment. The use of the telephone to deliver treatment services has been recommended as a way to reduce many of the barriers associated with failure to initiate and sustain treatment. When administered over the telephone, cognitive behavioral therapy (CBT), a form of psychotherapy that teaches ways to modify thoughts and behaviors that contribute to depression, may be superior to face-to-face CBT in improving treatment adherence and reducing depressive symptoms. This study will compare the effectiveness of telephone CBT (T-CBT) versus face-to-face CBT (FtF-CBT) in treating people with depression.

Participation in this study will include 18 weeks of treatment and 12 months of follow-up. All participants will first undergo baseline assessments that will include a telephone interview and questionnaires about mood. Participants will then be assigned randomly to receive T-CBT or FtF-CBT. Participants in both groups will receive eighteen 45-minute sessions of their assigned treatment over 18 weeks. Sessions will occur twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. During sessions, participants will learn ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made. Treatment sessions will be identical for both groups, except one group will receive sessions over the telephone and the other in-person at a study office. All participants will repeat the baseline assessments at Weeks 4, 9, 14, and 18 of treatment and Months 3, 6, 9, and 12 of follow-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 325

Inclusion Criteria

Has a current diagnosis of major depressive disorder
Has a primary care physician at Northwestern University in Illinois, or one of a number of approved community clinics in Chicago.
Resides in Illinois
Has a telephone
Speaks and reads English

Exclusion Criteria

Hearing, voice, or visual impairment
Meets criteria for dementia
Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous
Currently receiving individual psychotherapy or planning to receive psychotherapy during the treatment phase of the study
Planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time
Recent history of suicide attempts or is severely suicidal
Initiated treatment with an antidepressant in the 2 months before study entry (antidepressant medication is not exclusionary)
Depression determined to be primarily of an organic etiology

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone-administered CBT	Telephone-administered cognitive behavioral therapy (T-CBT)	Participants will receive telephone-administered cognitive behavioral therapy.
Face-to-face CBT	Face-to-face administered CBT (FtF-CBT)	Participants will receive face-to-face cognitive behavioral therapy.

Primary Outcome Measures

Name	Time	Method
Attrition (Number of Therapy Sessions Attended)	Post treatment, up to 18 weeks	Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)	Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up	Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant.
Number of Participants Who Dropped Out of Therapy	Post treatment, up to 18 weeks	Using the number of therapy sessions attended, we categorized patients into: 1. those who discontinued treatment before session 18, and those who completed session 18. 2. those who discontinued before Session 5, and those who continued.
Patient Health Questionnaire (PHQ)-9	Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up	Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment.

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)	Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up