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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Mohr, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00498706
First received: July 8, 2007
Last updated: July 15, 2013
Last verified: July 2013
  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 CBT (FtF-CBT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telephone Versus Face-to-Face Administration of CBT for Depression

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Attrition (Number of Therapy Sessions Attended) [ Time Frame: Post treatment, up to 18 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    Using the number of therapy sessions attended, we categorized patients into:

    1. those who discontinued treatment before session 18, and those who completed session 18.
    2. 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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 ]

Enrollment: 325
Study Start Date: December 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: David C. Mohr, PhD Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Mohr, Professor, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00498706     History of Changes
Other Study ID Numbers: R01 MH059708, R01MH059708
Study First Received: July 8, 2007
Results First Received: August 20, 2012
Last Updated: July 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
Depressive Disorder, Major
Cognitive Behavioral Therapy
Psychotherapy
Telemedicine
Primary Care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2014