title: 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.
abstract: BACKGROUND
  Major Depressive Disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences.
  
  
  OBJECTIVE
  This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower vs. higher risk for relapse; and 2) the subsequent durability of 8-month continuation phase therapies in randomized higher risk responders followed for an additional 24 months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to continuation phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX).
  
  
  METHODS
  Outpatients, aged 18 to 70 years, with recurrent MDD received 12-14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression <or=12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of continuation phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the continuation phase, higher risk patients were followed by blinded evaluators for 24 months.
  
  
  RESULTS
  The trial began in 2000. Enrollment is complete (n=523). The follow-up continues.
  
  
  CONCLUSIONS
  The trial evaluates the preventive effects and durability of acute and continuation phase treatments in the largest known sample of CT responders collected worldwide.
authors.affiliation: Department of Psychiatry, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, TX 75390-9149, USA. Robin.Jarrett@UTSouthwestern.edu
authors.forename: Robin B
authors.initials: RB
authors.lastname: Jarrett
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy; D003865:Major Depressive Disorder / Q000517:prevention & control* / Q000628:therapy; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012107:Research Design; D055502:Secondary Prevention; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine
references.citation: Arch Gen Psychiatry. 2006 Jul;63(7):749-55
references.pmid: 16818864
references.citation: Psychol Med. 2004 Jan;34(1):73-82
references.pmid: 14971628
references.citation: Acta Psychiatr Scand Suppl. 1987;334:1-100
references.pmid: 2887090
references.citation: Arch Gen Psychiatry. 1961 Jun;4:561-71
references.pmid: 13688369
references.citation: Psychiatry. 1994 May;57(2):115-32
references.pmid: 7938331
references.citation: Aust N Z J Psychiatry. 1976 Mar;10(1):27-32
references.pmid: 1065311
references.citation: Psychiatry Res. 1986 May;18(1):65-87
references.pmid: 3737788
references.citation: Psychol Assess. 2011 Sep;23(3):578-86
references.pmid: 21319902
references.citation: Arch Gen Psychiatry. 1987 Jun;44(6):540-8
references.pmid: 3579500
references.citation: Arch Gen Psychiatry. 1996 Aug;53(8):717-23
references.pmid: 8694685
references.citation: Psychiatry Clin Neurosci. 2006 Jun;60(3):358-64
references.pmid: 16732754
references.citation: J Consult Clin Psychol. 1974 Dec;42(6):861-5
references.pmid: 4436473
references.citation: J Psychiatr Res. 2001 Sep-Oct;35(5):297-305
references.pmid: 11591433
references.citation: J Clin Nurs. 2008 Feb;17(3):323-32
references.pmid: 17419785
references.citation: J Abnorm Psychol. 2003 Feb;112(1):72-80
references.pmid: 12653415
references.citation: Psychol Rep. 2008 Aug;103(1):243-70
references.pmid: 18982957
references.citation: J Psychiatr Res. 1994 Nov-Dec;28(6):531-45
references.pmid: 7699612
references.citation: N Engl J Med. 2008 Jan 17;358(3):252-60
references.pmid: 18199864
references.citation: Br J Psychiatry. 1998 Dec;173:519-22
references.pmid: 9926082
references.citation: Psychol Rep. 2007 Dec;101(3 Pt 1):920-6
references.pmid: 18232450
references.citation: J Nerv Ment Dis. 1969 Jan;148(1):87-98
references.pmid: 5768895
references.citation: J Affect Disord. 2008 Dec;111(2-3):185-92
references.pmid: 18358541
references.citation: J Abnorm Psychol. 2001 May;110(2):282-9
references.pmid: 11358022
references.citation: Int J Psychiatry Med. 2008;38(2):141-52
references.pmid: 18724566
references.citation: Br J Psychiatry Suppl. 1988 Sep;(3):69-76
references.pmid: 3150694
references.citation: Emotion. 2005 Sep;5(3):343-8
references.pmid: 16187869
references.citation: Psychiatry Clin Neurosci. 2003 Aug;57(4):441-6
references.pmid: 12839527
references.citation: Am J Psychiatry. 2007 May;164(5):739-52
references.pmid: 17475733
references.citation: Psychiatry Res. 1989 May;28(2):193-213
references.pmid: 2748771
references.citation: Am J Psychiatry. 1991 Aug;148(8):997-1008
references.pmid: 1853989
references.citation: Br J Math Stat Psychol. 2008 Nov;61(Pt 2):401-13
references.pmid: 17535485
references.citation: J Abnorm Psychol. 1983 May;92(2):173-84
references.pmid: 6863732
references.citation: Psychol Med. 2007 Jun;37(6):769-78
references.pmid: 17202001
references.citation: Arch Gen Psychiatry. 2005 Apr;62(4):409-16
references.pmid: 15809408
references.citation: J Stud Alcohol. 1989 May;50(3):202-9
references.pmid: 2724967
references.citation: Int J Soc Psychiatry. 2004 Jun;50(2):142-52
references.pmid: 15293431
references.citation: Lancet. 2003 Feb 22;361(9358):653-61
references.pmid: 12606176
references.citation: Qual Life Res. 2005 Dec;14(10):2323-8
references.pmid: 16328911
references.citation: J Clin Psychol. 2006 Sep;62(9):1197-204
references.pmid: 16810663
references.citation: J Clin Psychopharmacol. 1996 Oct;16(5):356-62
references.pmid: 8889907
references.citation: JAMA. 2003 Jun 18;289(23):3106-16
references.pmid: 12813116
references.citation: J Abnorm Psychol. 1999 Feb;108(1):51-7
references.pmid: 10066992
references.citation: Aging Ment Health. 2004 Mar;8(2):153-60
references.pmid: 14982720
references.citation: Qual Life Res. 2005 Sep;14(7):1693-703
references.pmid: 16119181
references.citation: Arch Gen Psychiatry. 1988 Aug;45(8):742-7
references.pmid: 3395203
references.citation: Psychol Med. 1978 Nov;8(4):577-88
references.pmid: 724871
references.citation: Psychol Assess. 2007 Jun;19(2):199-209
references.pmid: 17563201
references.citation: J Affect Disord. 2004 Mar;78(3):185-92
references.pmid: 15013242
references.citation: J Am Acad Child Adolesc Psychiatry. 2006 Apr;45(4):401-7
references.pmid: 16601644
references.citation: Arch Gen Psychiatry. 2001 Apr;58(4):381-8
references.pmid: 11296099
references.citation: J Fam Psychol. 2006 Sep;20(3):386-96
references.pmid: 16937995
references.citation: Schizophr Res. 1995 Jan;14(2):121-32
references.pmid: 7710992
references.citation: J Consult Clin Psychol. 1983 Aug;51(4):504-10
references.pmid: 6619356
references.citation: Arch Gen Psychiatry. 1982 Aug;39(8):911-5
references.pmid: 7103680
references.citation: Res Nurs Health. 2002 Dec;25(6):471-8
references.pmid: 12424784
references.citation: Acta Psychiatr Scand. 2007 Apr;115(4):326-30
references.pmid: 17355524
references.citation: Eur Psychiatry. 2008 Dec;23(8):575-9
references.pmid: 18774271
references.citation: J Abnorm Psychol. 1991 Aug;100(3):316-36
references.pmid: 1918611
references.citation: Am J Psychiatry. 1992 Aug;149(8):1046-52
references.pmid: 1636804
references.citation: J Abnorm Psychol. 1988 Feb;97(1):87-9
references.pmid: 3351118
references.citation: J Consult Clin Psychol. 2000 Jun;68(3):438-50
references.pmid: 10883561
references.citation: JAMA. 2004 Mar 3;291(9):1081-91
references.pmid: 14996777
references.citation: Behav Ther. 2009 Sep;40(3):302-14
references.pmid: 19647531
references.citation: Am J Psychiatry. 1973 Apr;130(4):455-9
references.pmid: 4691303
references.citation: Br J Psychiatry. 2000 Jul;177:4-7
references.pmid: 10945080
references.citation: Am Psychol. 1995 Dec;50(12):965-74
references.pmid: 8561380
references.citation: J Clin Psychol. 2009 Jan;65(1):20-35
references.pmid: 19051242
references.citation: J Affect Disord. 1991 Dec;23(4):223-9
references.pmid: 1791268
references.citation: J Abnorm Psychol. 1983 Feb;92(1):107-9
references.pmid: 6833629
references.citation: Br J Med Psychol. 1994 Jun;67 ( Pt 2):171-85
references.pmid: 7918212
references.citation: J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62
references.pmid: 14399272
references.citation: Psychopharmacol Bull. 1973 Jan;9(1):13-28
references.pmid: 4682398
references.citation: J Abnorm Psychol. 1989 Aug;98(3):229-35
references.pmid: 2768657
references.citation: J Consult Clin Psychol. 2007 Jun;75(3):475-88
references.pmid: 17563164
references.citation: J Consult Clin Psychol. 1986 Jun;54(3):381-5
references.pmid: 3722567
references.citation: J Clin Psychiatry. 2006 May;67(5):747-55
references.pmid: 16841624
references.citation: Arch Gen Psychiatry. 1976 Jun;33(6):766-71
references.pmid: 938196
references.citation: Am J Psychiatry. 2007 Jul;164(7):989-91
references.pmid: 17606644
references.citation: Psychopharmacol Bull. 1993;29(2):321-6
references.pmid: 8290681
references.citation: Psychopharmacol Bull. 1988;24(1):183-8
references.pmid: 3290940
references.citation: J Abnorm Psychol. 1999 Feb;108(1):3-10
references.pmid: 10066988
references.citation: Br J Psychiatry. 1977 Jul;131:49-52
references.pmid: 884416
references.citation: Psychother Res. 2005 Jul;15(3):272-86
references.pmid: 22011156
references.citation: Arch Gen Psychiatry. 1987 Sep;44(9):817-20
references.pmid: 3632255
references.citation: Arch Gen Psychiatry. 1982 Aug;39(8):905-10
references.pmid: 7103679
references.citation: Behav Res Ther. 2008 Oct;46(10):1142-50
references.pmid: 18707676
references.citation: Am J Psychiatry. 2007 Jul;164(7):1035-43
references.pmid: 17606655
references.citation: Am J Psychiatry. 1985 May;142(5):559-63
references.pmid: 3985195
references.citation: Behav Res Ther. 2010 Jun;48(6):449-58
references.pmid: 20163785
references.citation: J Consult Clin Psychol. 1998 Dec;66(6):1036-40
references.pmid: 9874918
references.citation: Arch Gen Psychiatry. 1986 Nov;43(11):1076-81
references.pmid: 3767597
references.citation: Psychol Med. 1985 Feb;15(1):189-94
references.pmid: 3991833
references.citation: CNS Spectr. 2006 Dec;11(12 Suppl 15):12-21
references.pmid: 17146414
references.citation: Psychol Med. 2005 Jan;35(1):59-68
references.pmid: 15842029
references.citation: Psychopharmacol Bull. 1987;23(2):309-24
references.pmid: 3303100
references.citation: J Abnorm Psychol. 2003 Aug;112(3):488-96
references.pmid: 12943027
references.citation: J Psychosom Res. 1998 Jul;45(1):5-13
references.pmid: 9720850
references.citation: J Abnorm Psychol. 1994 Feb;103(1):18-31
references.pmid: 8040477
references.citation: J Clin Psychol. 1967 Jan;23(1):94-6
references.pmid: 6031042
references.citation: J Abnorm Psychol. 2007 Aug;116(3):475-83
references.pmid: 17696703
references.citation: Med Care. 1988 Jul;26(7):724-35
references.pmid: 3393032
references.citation: Cognit Ther Res. 2009 Aug;33(4):345-355
references.pmid: 19623267
references.citation: Arch Gen Psychiatry. 1976 Sep;33(9):1111-5
references.pmid: 962494
references.citation: J Consult Clin Psychol. 1988 Dec;56(6):885-92
references.pmid: 3204198
references.citation: J Abnorm Child Psychol. 1995 Oct;23(5):597-606
references.pmid: 8568082
references.citation: West J Nurs Res. 2008 Feb;30(1):113-29
references.pmid: 18029543
references.citation: J Fam Psychol. 2001 Jun;15(2):225-40
references.pmid: 11458630
references.citation: Psychol Bull. 1978 Sep;85(5):1154-76
references.pmid: 704721
references.citation: J Nerv Ment Dis. 1978 May;166(5):317-26
references.pmid: 650195
references.citation: Pain. 2000 Apr;85(3):457-463
references.pmid: 10781919
references.citation: JAMA. 1975 Dec 15;234(11):1146-9
references.pmid: 1242427
references.citation: Cogn Behav Ther. 2004;33(2):83-6
references.pmid: 15279314
references.citation: J Psychiatr Res. 1999 Mar-Apr;33(2):105-12
references.pmid: 10221742
references.citation: Med Care. 1995 Jan;33(1):67-74
references.pmid: 7823648
references.citation: J Clin Psychiatry. 2005 Apr;66(4):455-68
references.pmid: 15816788
references.citation: J Pers Soc Psychol. 2005 Apr;88(4):673-85
references.pmid: 15796667
references.citation: Assessment. 2004 Sep;11(3):238-50
references.pmid: 15358880
references.citation: Acta Psychiatr Scand. 1990 Jul;82(1):77-81
references.pmid: 2399824
references.citation: N Engl J Med. 2000 May 18;342(20):1462-70
references.pmid: 10816183
references.citation: J Clin Psychopharmacol. 2009 Feb;29(1):82-5
references.pmid: 19142114