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Cognitive Therapy for Recurrent Depression

This study has been completed.
Sponsor:
Collaborator:
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

July 6, 2005
May 13, 2014
March 2000
July 2008   (final data collection date for primary outcome measure)
  • Depressive Relapse or MDD [ Time Frame: Measured at month 8 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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
Complete list of historical versions of study NCT00118404 on ClinicalTrials.gov Archive Site
Not Provided
Psychosocial functioning
Not Provided
Not Provided
 
Cognitive Therapy for Recurrent Depression
Prophylactic Cognitive Therapy for Depression.

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
523
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118404
R01 MH58397, R01MH058397, R01MH069619, R01MH058356, R01MH069618
Yes
Robin Jarrett, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
Principal Investigator: Robin B. Jarrett, PhD University of Texas Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
May 2014

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