NCT00118404

Brief Summary

This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
523

participants targeted

Target at P75+ for phase_3 depression

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_3 depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

June 5, 2014

Completed
Last Updated

June 5, 2014

Status Verified

May 1, 2014

Enrollment Period

8.3 years

First QC Date

July 6, 2005

Results QC Date

December 12, 2013

Last Update Submit

May 13, 2014

Conditions

Depression

Keywords

Cognitive therapyAntidepressantsPsychotherapy

Outcome Measures

Primary Outcomes (3)

  • Depressive Relapse or MDD

    Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)

    Measured at month 8

  • Depressive Relapse/Recurrence or MDD

    Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)

    Measured at month 20

  • Depressive Relapse/Recurrence or MDD

    Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481).

    Measured at month 32

Study Arms (3)

1

EXPERIMENTAL

Participants received acute phase and continuation phase cognitive therapy

Behavioral: Continuation phase cognitive therapyBehavioral: Acute phase cognitive therapy

2

PLACEBO COMPARATOR

Participants received acute phase cognitive therapy and continuation phase pill placebo

Other: Continuation phase pill placeboBehavioral: Acute phase cognitive therapy

3

ACTIVE COMPARATOR

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Drug: Continuation phase fluoxetineBehavioral: Acute phase cognitive therapy

Interventions

Continuation phase cognitive therapyBEHAVIORAL

Continuation phase cognitive therapy included 10 sessions over 8 months.

1
Continuation phase fluoxetineDRUG

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

Also known as: Prozac
3
Continuation phase pill placeboOTHER

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

2
Acute phase cognitive therapyBEHAVIORAL

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

123

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent unipolar major depressive disorder
  • 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

You may not qualify if:

  • Active alcohol or other substance dependence within 6 months prior to study entry
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (14)

  • 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.

    PMID: 20451668BACKGROUND

  • 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.

    PMID: 21319902RESULT

  • 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.

    PMID: 21781377RESULT

  • 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.

    PMID: 22398963RESULT

  • 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.

    PMID: 22306232RESULT

  • 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.

    PMID: 22445946RESULT

  • 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.

    PMID: 23305218RESULT

  • 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.

    PMID: 23485420RESULT

  • 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.

    PMID: 24005123RESULT

  • 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.

    PMID: 23627652RESULT

  • 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.

    PMID: 23786268RESULT

  • 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.

    PMID: 30824246DERIVED

  • 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.

    PMID: 26348032DERIVED

  • 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.

    PMID: 24643964DERIVED

Related Links

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Limitations and Caveats

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.

Results Point of Contact

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

Study Officials

  • Robin B. Jarrett, PhD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 11, 2005

Study Start

March 1, 2000

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 5, 2014

Results First Posted

June 5, 2014

Record last verified: 2014-05

Locations

US(2)