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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   Information provided by National Institute of Mental Health (NIMH)
First Received: July 8, 2007   Last Updated: April 8, 2009   History of Changes

July 8, 2007
April 8, 2009
December 2007
July 2010   (final data collection date for 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 ]
Attrition (patient drop-out), number of sessions attended, depression (Hamilton Rating Scale for Depression, M.I.N.I.) [ Time Frame: All outcomes will be measured at baseline, and weeks 4, 8, 12, and 16 (post-treatment). Post-treatment follow-ups will be collected at months 3, 6, 9, and 12. ]
Complete list of historical versions of study NCT00498706 on ClinicalTrials.gov Archive Site
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 ]
Health-related quality of life (SF-36V), patient satisfaction (Satisfaction Index – Mental Health), therapeutic alliance (Working Alliance Inventory – Short Form) [ Time Frame: All outcomes will be measured at baseline, and weeks 4, 8, 12, and 16 (post-treatment). Post-treatment follow-ups will be collected at months 3, 6, 9, and 12. ]
 
Effectiveness of Telephone Versus Face-to-Face Administered Cognitive Behavioral Therapy in Treating People With Depression
Telephone Versus Face-to-Face Administration of CBT for Depression

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

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Depression
  • Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)
  • Behavioral: Face-to-face administered cognitive behavioral therapy (FtF-CBT)
  • Experimental: Participants will receive telephone-administered cognitive behavioral therapy.
  • Active Comparator: Participants will receive face-to-face cognitive behavioral therapy.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
240
November 2011
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Joyce Ho, PhD 312-503-5387 j-ho@northwestern.edu
Contact: David C. Mohr, PhD 312-503-1403 d-mohr@northwestern.edu
United States
 
NCT00498706
David C. Mohr, PhD/Professor, Northwestern University
R01 MH059708, DSIR 83-ATAS
National Institute of Mental Health (NIMH)
 
Principal Investigator: David C. Mohr, PhD Northwestern University
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP