Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
523 participants
INTERVENTIONAL
2000-03-31
2008-07-31
Brief Summary
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Detailed Description
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This study lasted approximately 36 months and comprised three phases. For the first 12 weeks, all participants received between 16 and 20 CT sessions. Participants were then randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants entered follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires were used to assess depressive symptoms of participants at study start and at the end of each study phase.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Participants received acute phase and continuation phase cognitive therapy
Continuation phase cognitive therapy
Continuation phase cognitive therapy included 10 sessions over 8 months.
Acute phase cognitive therapy
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
2
Participants received acute phase cognitive therapy and continuation phase pill placebo
Continuation phase pill placebo
The dosage of pill placebo was increased to 40 mg over 8 months.
Acute phase cognitive therapy
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
3
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Continuation phase fluoxetine
The dosage of fluoxetine was increased to 40 mg over 8 months.
Acute phase cognitive therapy
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Interventions
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Continuation phase cognitive therapy
Continuation phase cognitive therapy included 10 sessions over 8 months.
Continuation phase fluoxetine
The dosage of fluoxetine was increased to 40 mg over 8 months.
Continuation phase pill placebo
The dosage of pill placebo was increased to 40 mg over 8 months.
Acute phase cognitive therapy
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have experienced at least two episodes of major depression
* Have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
* Willing and able to comply with all study requirements
* Able to speak and read English
Exclusion Criteria
* Currently at risk for suicide
* Mood disorders due to a medical condition or substance abuse
* Bipolar, schizoaffective, obsessive compulsive, or eating disorders
* Schizophrenia
* Unable to stop mood-altering medications
* Current use of medication or diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis)
* Previous failure to experience a reduction in depressive symptoms after 8 weeks of cognitive therapy with a certified therapist
* Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac
* Pregnancy or plan to become pregnant in the next 11-12 months
* Unable to attend clinic twice weekly during business hours
* Unable to complete questionnaires
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Robin Jarrett
Professor of Psychiatry
Principal Investigators
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Robin B. Jarrett, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Southwestern Medical Center at Dallas
Locations
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University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Countries
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References
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Jarrett RB, Thase ME. Comparative efficacy and durability of continuation phase cognitive therapy for preventing recurrent depression: design of a double-blinded, fluoxetine- and pill placebo-controlled, randomized trial with 2-year follow-up. Contemp Clin Trials. 2010 Jul;31(4):355-77. doi: 10.1016/j.cct.2010.04.004. Epub 2010 May 6.
Jarrett RB, Vittengl JR, Clark LA, Thase ME. Skills of Cognitive Therapy (SoCT): a new measure of patients' comprehension and use. Psychol Assess. 2011 Sep;23(3):578-86. doi: 10.1037/a0022485.
Dunn TW, Vittengl JR, Clark LA, Carmody T, Thase ME, Jarrett RB. Change in psychosocial functioning and depressive symptoms during acute-phase cognitive therapy for depression. Psychol Med. 2012 Feb;42(2):317-26. doi: 10.1017/S0033291711001279. Epub 2011 Jul 25.
Smits JA, Minhajuddin A, Thase ME, Jarrett RB. Outcomes of acute phase cognitive therapy in outpatients with anxious versus nonanxious depression. Psychother Psychosom. 2012;81(3):153-60. doi: 10.1159/000334909. Epub 2012 Mar 3.
Renner F, Jarrett RB, Vittengl JR, Barrett MS, Clark LA, Thase ME. Interpersonal problems as predictors of therapeutic alliance and symptom improvement in cognitive therapy for depression. J Affect Disord. 2012 May;138(3):458-67. doi: 10.1016/j.jad.2011.12.044. Epub 2012 Feb 4.
Jarrett RB, Minhajuddin A, Borman PD, Dunlap L, Segal ZV, Kidner CL, Friedman ES, Thase ME. Cognitive reactivity, dysfunctional attitudes, and depressive relapse and recurrence in cognitive therapy responders. Behav Res Ther. 2012 May;50(5):280-6. doi: 10.1016/j.brat.2012.01.008. Epub 2012 Feb 21.
Brandon AR, Minhajuddin A, Thase ME, Jarrett RB. Impact of reproductive status and age on response of depressed women to cognitive therapy. J Womens Health (Larchmt). 2013 Jan;22(1):58-66. doi: 10.1089/jwh.2011.3427.
Jarrett RB, Minhajuddin A, Kangas JL, Friedman ES, Callan JA, Thase ME. Acute phase cognitive therapy for recurrent major depressive disorder: who drops out and how much do patient skills influence response? Behav Res Ther. 2013 May;51(4-5):221-30. doi: 10.1016/j.brat.2013.01.006.
Jarrett RB, Minhajuddin A, Gershenfeld H, Friedman ES, Thase ME. Preventing depressive relapse and recurrence in higher-risk cognitive therapy responders: a randomized trial of continuation phase cognitive therapy, fluoxetine, or matched pill placebo. JAMA Psychiatry. 2013 Nov;70(11):1152-60. doi: 10.1001/jamapsychiatry.2013.1969.
Vittengl JR, Clark LA, Thase ME, Jarrett RB. Nomothetic and idiographic symptom change trajectories in acute-phase cognitive therapy for recurrent depression. J Consult Clin Psychol. 2013 Aug;81(4):615-26. doi: 10.1037/a0032879. Epub 2013 Apr 29.
Vittengl JR, Clark LA, Thase ME, Jarrett RB. Replication and extension: separate personality traits from states to predict depression. J Pers Disord. 2014 Apr;28(2):225-46. doi: 10.1521/pedi_2013_27_117. Epub 2013 Jun 20.
Callan JA, Kazantzis N, Park SY, Moore CG, Thase ME, Minhajuddin A, Kornblith S, Siegle GJ. A Propensity Score Analysis of Homework Adherence-Outcome Relations in Cognitive Behavioral Therapy for Depression. Behav Ther. 2019 Mar;50(2):285-299. doi: 10.1016/j.beth.2018.05.010. Epub 2018 Jun 5.
Brown GK, Thase ME, Vittengl JR, Borman PD, Clark LA, Jarrett RB. Assessing cognitive therapy skills comprehension, acquisition, and use by means of an independent observer version of the Skills of Cognitive Therapy (SoCT-IO). Psychol Assess. 2016 Feb;28(2):205-13. doi: 10.1037/pas0000080. Epub 2015 Sep 7.
Horner MS, Siegle GJ, Schwartz RM, Price RB, Haggerty AE, Collier A, Friedman ES. C'mon get happy: reduced magnitude and duration of response during a positive-affect induction in depression. Depress Anxiety. 2014 Nov;31(11):952-60. doi: 10.1002/da.22244. Epub 2014 Mar 18.
Related Links
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Psychosocial Research and Depression Clinic
Other Identifiers
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NCT00183664
Identifier Type: -
Identifier Source: nct_alias
NCT00218764
Identifier Type: -
Identifier Source: nct_alias
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