Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telephone-administered cognitive behavioral therapy (T-CBT)
Face-to-face administered CBT (FtF-CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depressive Disorder, Major, Cognitive Behavioral Therapy, Psychotherapy, Telemedicine, Primary Care
Eligibility 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
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telephone-administered CBT
Face-to-face CBT
Arm Description
Participants will receive telephone-administered cognitive behavioral therapy.
Participants will receive face-to-face cognitive behavioral therapy.
Outcomes
Primary Outcome Measures
Attrition (Number of Therapy Sessions Attended)
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
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
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)
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)
Full Information
NCT ID
NCT00498706
First Posted
July 8, 2007
Last Updated
July 15, 2013
Sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00498706
Brief Title
Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression
Official Title
Telephone Versus Face-to-Face Administration of CBT for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depressive Disorder, Major, Cognitive Behavioral Therapy, Psychotherapy, Telemedicine, Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone-administered CBT
Arm Type
Experimental
Arm Description
Participants will receive telephone-administered cognitive behavioral therapy.
Arm Title
Face-to-face CBT
Arm Type
Active Comparator
Arm Description
Participants will receive face-to-face cognitive behavioral therapy.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-administered cognitive behavioral therapy (T-CBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face administered CBT (FtF-CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attrition (Number of Therapy Sessions Attended)
Description
Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.
Time Frame
Post treatment, up to 18 weeks
Title
Number of Participants Who Dropped Out of Therapy
Description
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.
Time Frame
Post treatment, up to 18 weeks
Title
Patient Health Questionnaire (PHQ)-9
Description
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.
Time Frame
Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up
Title
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)
Description
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.
Time Frame
Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Mohr, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22706833
Citation
Mohr DC, Ho J, Duffecy J, Reifler D, Sokol L, Burns MN, Jin L, Siddique J. Effect of telephone-administered vs face-to-face cognitive behavioral therapy on adherence to therapy and depression outcomes among primary care patients: a randomized trial. JAMA. 2012 Jun 6;307(21):2278-85. doi: 10.1001/jama.2012.5588.
Results Reference
derived
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Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression
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