Research Evaluating the Value of Augmenting Medication With Psychotherapy
NCT ID: NCT00057551
Last Updated: 2017-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
491 participants
INTERVENTIONAL
2003-04-30
2007-03-31
Brief Summary
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Detailed Description
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Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CBASP
Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
CBASP
psychotherapy developed for chronic depression
Brief Supportive Psychotherapy
Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Brief Supportive Psychotherapy
brief supportive psychotherapy
Medication Only
Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
Medication Only
antidepressant medication
Interventions
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Brief Supportive Psychotherapy
brief supportive psychotherapy
CBASP
psychotherapy developed for chronic depression
Medication Only
antidepressant medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Depressive symptoms \> 2 years without remission
* Hamilton Depression Scale (HAM-D) score \> 20
* Fluent in English
Exclusion Criteria
* Serious, unstable, or terminal medical condition
* Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
* Previous treatment with CBASP
* Previous ineffective treatment with 4 of the medication treatments used in the study
* Substance abuse
* Pregnancy
* Not willing to end other psychiatric treatment
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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James H Kocsis
Role: PRINCIPAL_INVESTIGATOR
weill cornell mc
Locations
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Emory University
Atlanta, Georgia, United States
Weill-Cornell Medical College Payne Whitney Clinic
New York, New York, United States
SUNY- Stony Brook
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
University of Arizona
Tucson, Arizona, United States
Stanford University
Palo Alto, California, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Keller MB, McCullough JP, Klein DN, Arnow B, Dunner DL, Gelenberg AJ, Markowitz JC, Nemeroff CB, Russell JM, Thase ME, Trivedi MH, Zajecka J. A comparison of nefazodone, the cognitive behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression. N Engl J Med. 2000 May 18;342(20):1462-70. doi: 10.1056/NEJM200005183422001.
Keller MB, Kocsis JH, Thase ME, Gelenberg AJ, Rush AJ, Koran L, Schatzberg A, Russell J, Hirschfeld R, Klein D, McCullough JP, Fawcett JA, Kornstein S, LaVange L, Harrison W. Maintenance phase efficacy of sertraline for chronic depression: a randomized controlled trial. JAMA. 1998 Nov 18;280(19):1665-72. doi: 10.1001/jama.280.19.1665.
McCullough JP Jr. Treatment for chronic depression using Cognitive Behavioral Analysis System of Psychotherapy (CBASP). J Clin Psychol. 2003 Aug;59(8):833-46. doi: 10.1002/jclp.10176.
Shankman SA, Gorka SM, Katz AC, Klein DN, Markowitz JC, Arnow BA, Manber R, Rothbaum BO, Thase ME, Schatzberg AF, Keller MB, Trivedi MH, Kocsis JH. Side Effects to Antidepressant Treatment in Patients With Depression and Comorbid Panic Disorder. J Clin Psychiatry. 2017 Apr;78(4):433-440. doi: 10.4088/JCP.15m10370.
Shankman SA, Campbell ML, Klein DN, Leon AC, Arnow BA, Manber R, Keller MB, Markowitz JC, Rothbaum BO, Thase ME, Kocsis JH. Dysfunctional attitudes as a moderator of pharmacotherapy and psychotherapy for chronic depression. J Psychiatr Res. 2013 Jan;47(1):113-21. doi: 10.1016/j.jpsychires.2012.09.018. Epub 2012 Oct 25.
Klein DN, Leon AC, Li C, D'Zurilla TJ, Black SR, Vivian D, Dowling F, Arnow BA, Manber R, Markowitz JC, Kocsis JH. Social problem solving and depressive symptoms over time: a randomized clinical trial of cognitive-behavioral analysis system of psychotherapy, brief supportive psychotherapy, and pharmacotherapy. J Consult Clin Psychol. 2011 Jun;79(3):342-52. doi: 10.1037/a0023208.
Kocsis JH, Gelenberg AJ, Rothbaum BO, Klein DN, Trivedi MH, Manber R, Keller MB, Leon AC, Wisniewski SR, Arnow BA, Markowitz JC, Thase ME; REVAMP Investigators. Cognitive behavioral analysis system of psychotherapy and brief supportive psychotherapy for augmentation of antidepressant nonresponse in chronic depression: the REVAMP Trial. Arch Gen Psychiatry. 2009 Nov;66(11):1178-88. doi: 10.1001/archgenpsychiatry.2009.144.
Other Identifiers
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