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

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

Detailed Description
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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.

Official Title
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Telephone Versus Face-to-Face Administration of CBT for Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)
* Behavioral: Face-to-face administered CBT (FtF-CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone-administered CBT<br>Participants will receive telephone-administered cognitive behavioral therapy. | Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)<br>* Over 18 weeks, participants will receive eighteen 45-minute sessions of T-CBT administered by a therapist. Participants will undergo telephone-administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.<br>|
| Active Comparator: Face-to-face CBT<br>Participants will receive face-to-face cognitive behavioral therapy. | Behavioral: Face-to-face administered CBT (FtF-CBT)<br>* Over 18 weeks, participants will receive eighteen 45-minute sessions of FtF-CBT administered by a therapist. Participants will undergo face-to-face administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition (Number of Therapy Sessions Attended) | Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected. | Post treatment, up to 18 weeks | 
| Number of Participants Who Dropped Out of Therapy | Using the number of therapy sessions attended, we categorized patients into: those who discontinued treatment before session 18, and those who completed session 18. those who discontinued before Session 5, and those who continued. | Post treatment, up to 18 weeks | 
| Patient Health Questionnaire (PHQ)-9 | 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. | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up | 
| Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | 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. | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive Disorder, Major, Cognitive Behavioral Therapy, Psychotherapy, Telemedicine, Primary Care