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Effectiveness of Telephone Versus Face-to-Face Administered Cognitive Behavioral Therapy in Treating People With Depression

This study is currently recruiting participants.
Study NCT00498706.   Last updated on July 23, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Telephone Versus Face-to-Face Administered Cognitive Behavioral Therapy in Treating People With Depression
Official Title  Telephone Versus Face-to-Face Administration of CBT for Depression
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.

Study Phase Phase II, Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Attrition (e.g., number of sessions attended, dropout rate) [ Time Frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up ] [ Designated as safety issue: No ]
Depression, as assessed by Patient Health Questionnaire (PHQ)-9, Hamilton Rating Scale for Depression, and Mini International Neuropsychiatric Interview (MINI) [ Time Frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ] [ Designated as safety issue: No ]
Condition  Depression
Intervention  Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)
Behavioral: Face-to-face administered cognitive behavioral therapy (FtF-CBT)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  240
Start Date  December 2007
Completion Date October 2011
Eligibility Criteria 

Inclusion Criteria:

  • Has a current diagnosis of major depressive disorder
  • Has a primary care physician at Northwestern University in Illinois
  • 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Joyce Ho, PhD     312-503-5387     j-ho@northwestern.edu    
Contact: David C. Mohr, PhD     312-503-1403     d-mohr@northwestern.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00498706
Organization ID R01 MH059708
Secondary IDs †† DSIR 83-ATAS
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     David C. Mohr, PhD     Northwestern University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date July 2008
First Received Date  July 8, 2007
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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