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Cognitive Therapy for Recurrent Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00118404
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robin Jarrett, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE July 6, 2005
First Posted Date  ICMJE July 11, 2005
Results First Submitted Date  ICMJE December 12, 2013
Results First Posted Date  ICMJE June 5, 2014
Last Update Posted Date June 5, 2014
Study Start Date  ICMJE March 2000
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • Depressive Relapse or MDD [ Time Frame: Measured at month 8 ]
    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)
  • Depressive Relapse/Recurrence or MDD [ Time Frame: Measured at month 20 ]
    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)
  • Depressive Relapse/Recurrence or MDD [ Time Frame: Measured at month 32 ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2005)
Depressive relapse
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2005)
Psychosocial functioning
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Therapy for Recurrent Depression
Official Title  ICMJE Prophylactic Cognitive Therapy for Depression.
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.
Detailed Description

Cognitive therapy (CT) is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determine the effectiveness of cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Behavioral: Continuation phase cognitive therapy
    Continuation phase cognitive therapy included 10 sessions over 8 months.
  • Drug: Continuation phase fluoxetine
    The dosage of fluoxetine was increased to 40 mg over 8 months.
    Other Name: Prozac
  • Other: Continuation phase pill placebo
    The dosage of pill placebo was increased to 40 mg over 8 months.
  • Behavioral: Acute phase cognitive therapy
    For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Study Arms  ICMJE
  • Experimental: 1
    Participants received acute phase and continuation phase cognitive therapy
    Interventions:
    • Behavioral: Continuation phase cognitive therapy
    • Behavioral: Acute phase cognitive therapy
  • Placebo Comparator: 2
    Participants received acute phase cognitive therapy and continuation phase pill placebo
    Interventions:
    • Other: Continuation phase pill placebo
    • Behavioral: Acute phase cognitive therapy
  • Active Comparator: 3
    Participants received acute phase cognitive therapy and continuation phase fluoxetine
    Interventions:
    • Drug: Continuation phase fluoxetine
    • Behavioral: Acute phase cognitive therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2008)
523
Original Enrollment  ICMJE
 (submitted: July 6, 2005)
498
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00118404
Other Study ID Numbers  ICMJE R01MH058397( U.S. NIH Grant/Contract )
R01MH058397 ( U.S. NIH Grant/Contract )
R01MH069619 ( U.S. NIH Grant/Contract )
R01MH058356 ( U.S. NIH Grant/Contract )
R01MH069618 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robin Jarrett, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Robin B. Jarrett, PhD University of Texas, Southwestern Medical Center at Dallas
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP