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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.
Verified by National Institute of Mental Health (NIMH), July 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00498706
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)
Behavioral: Face-to-face administered cognitive behavioral therapy (FtF-CBT)
Phase II
Phase III

MedlinePlus related topics:   Depression    Mental Health   

ChemIDplus related topics:   Benzocaine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Telephone Versus Face-to-Face Administration of CBT for Depression

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment:   240
Study Start Date:   December 2007
Estimated Study Completion Date:   October 2011
Estimated Primary Completion Date:   October 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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.
2: Active Comparator
Participants will receive face-to-face cognitive behavioral therapy.
Behavioral: Face-to-face administered cognitive behavioral therapy (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.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498706

Contacts
Contact: Joyce Ho, PhD     312-503-5387     j-ho@northwestern.edu    
Contact: David C. Mohr, PhD     312-503-1403     d-mohr@northwestern.edu    

Locations
United States, Illinois
Northwestern University     Recruiting
      Chicago, Illinois, United States, 60611
      Contact: Joyce Ho, PhD     312-503-5387     j-ho@northwestern.edu    
      Contact: David C. Mohr, PhD     312-503-1403     d-mohr@northwestern.edu    
      Principal Investigator: David C. Mohr, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     David C. Mohr, PhD     Northwestern University    
  More Information

Responsible Party:   Northwestern University ( David C. Mohr, PhD/Professor )
Study ID Numbers:   R01 MH059708, DSIR 83-ATAS
First Received:   July 8, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00498706
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Depressive Disorder, Major  
Cognitive Behavioral Therapy  
Psychotherapy  
Telemedicine  
Primary Care  

Study placed in the following topic categories:
Depression
Facies
Mental Disorders
Benzocaine
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 29, 2008




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