Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression
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|ClinicalTrials.gov Identifier: NCT00498706|
Recruitment Status : Completed
First Posted : July 10, 2007
Results First Posted : July 17, 2013
Last Update Posted : July 17, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT) Behavioral: Face-to-face administered CBT (FtF-CBT)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||325 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Telephone Versus Face-to-Face Administration of CBT for Depression|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Telephone-administered CBT
Participants will receive telephone-administered cognitive behavioral therapy.
Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)
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.
Active Comparator: Face-to-face CBT
Participants will receive face-to-face cognitive behavioral therapy.
Behavioral: Face-to-face administered CBT (FtF-CBT)
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.
- Attrition (Number of Therapy Sessions Attended) [ Time Frame: 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.
- Number of Participants Who Dropped Out of Therapy [ Time Frame: Post treatment, up to 18 weeks ]
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.
- Patient Health Questionnaire (PHQ)-9 [ Time Frame: 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.
- Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) [ Time Frame: 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.
- Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form) [ Time Frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498706
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||David C. Mohr, PhD||Northwestern University|
|Responsible Party:||David Mohr, Professor, National Institute of Mental Health (NIMH)|
|Other Study ID Numbers:||
R01MH059708 ( U.S. NIH Grant/Contract )
R01MH059708 ( U.S. NIH Grant/Contract )
|First Posted:||July 10, 2007 Key Record Dates|
|Results First Posted:||July 17, 2013|
|Last Update Posted:||July 17, 2013|
|Last Verified:||July 2013|
Depressive Disorder, Major
Cognitive Behavioral Therapy