Cognitive Therapy for Recurrent Depression

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Robin Jarrett, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT00118404

First received: July 6, 2005

Last updated: May 13, 2014

Last verified: May 2014

History of Changes

Results First Received: December 12, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Depression
Interventions:	Behavioral: Continuation phase cognitive therapy Drug: Continuation phase fluoxetine Other: Continuation phase pill placebo Behavioral: Acute phase cognitive therapy

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult outpatients diagnosed with recurrent major depressive disorder (MDD) using the Structured Clinical Interview for Diagnostic and Statistical Manual-IV were recruited from January 2000-July 2008. The first diagnostic evaluation was completed in March 2000.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients (n=523) entered 12-14 weeks of acute phase cognitive therapy. Responders (no MDD & Hamilton Rating Scale for Depression [HRSD] ≤12) were divided by lower & higher risk based on the final 7 HRSD scores. Only consenting, higher risk patients (N=241) were randomized into the 3 arms below. See Jarrett &Thase (2010) for design details.

Reporting Groups

	Description
Continuation Phase Fluoxetine	Participants received acute phase cognitive therapy and continuation phase pill placebo Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions. Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.
Continuation Phase Cognitive Therapy	Participants received acute phase and continuation phase cognitive therapy Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions. Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.
Continuation Phase Pill Placebo	Participants received acute phase cognitive therapy and continuation phase fluoxetine Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions. Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

Description

Continuation Phase Fluoxetine

Participants received acute phase cognitive therapy and continuation phase pill placebo

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.

Continuation Phase Cognitive Therapy

Participants received acute phase and continuation phase cognitive therapy

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.

Continuation Phase Pill Placebo

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

Participant Flow: Overall Study

	Continuation Phase Fluoxetine	Continuation Phase Cognitive Therapy	Continuation Phase Pill Placebo
STARTED	86	86	69
COMPLETED	62	70	49
NOT COMPLETED	24	16	20

Baseline Characteristics

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Outcome Measures

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1. Primary:

Depressive Relapse or MDD [ Time Frame: Measured at month 8 ]

Show Outcome Measure 1

2. Primary:

Depressive Relapse/Recurrence or MDD [ Time Frame: Measured at month 20 ]

Show Outcome Measure 2

3. Primary:

Depressive Relapse/Recurrence or MDD [ Time Frame: Measured at month 32 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
To our knowledge in 2014 this is of the largest, cognitive therapy responders who presented with recurrent MDD and were followed longitudinally Proficient therapists;competency measured. Generalizability is limited by design characteristics.

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

To our knowledge in 2014 this is of the largest, cognitive therapy responders who presented with recurrent MDD and were followed longitudinally

Proficient therapists;competency measured.

Generalizability is limited by design characteristics.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Robin B. Jarrett, Professor of Psychiatry
Organization: The University of Texas Southwestern Medical Center
phone: 214-648-5345
e-mail: Robin.Jarrett@UTSouthwestern.edu

Publications of Results:

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.

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.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Robin Jarrett, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00118404 History of Changes
Obsolete Identifiers:	NCT00183664, NCT00218764
Other Study ID Numbers:	R01MH058397 ( U.S. NIH Grant/Contract ) R01MH069619 ( U.S. NIH Grant/Contract ) R01MH058356 ( U.S. NIH Grant/Contract ) R01MH069618 ( U.S. NIH Grant/Contract )
Study First Received:	July 6, 2005
Results First Received:	December 12, 2013
Last Updated:	May 13, 2014

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