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
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Continuation phase cognitive therapy
Drug: Continuation phase fluoxetine
Other: Continuation phase pill placebo
Behavioral: Acute phase cognitive therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Cognitive Therapy for Depression.

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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).



Enrollment: 523
Study Start Date: March 2000
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants received acute phase and continuation phase cognitive therapy
Behavioral: Continuation phase cognitive therapy
Continuation phase cognitive therapy included 10 sessions over 8 months.
Behavioral: Acute phase cognitive therapy
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Placebo Comparator: 2
Participants received acute phase cognitive therapy and continuation phase pill placebo
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.
Active Comparator: 3
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Drug: Continuation phase fluoxetine
The dosage of fluoxetine was increased to 40 mg over 8 months.
Other Name: Prozac
Behavioral: Acute phase cognitive therapy
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118404

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robin B. Jarrett, PhD University of Texas Southwestern Medical Center at Dallas
  More Information

Additional Information:
Publications:

Responsible Party: Robin Jarrett, Professor of Psychiatry, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00118404     History of Changes
Other Study ID Numbers: R01 MH58397, R01MH058397, R01MH069619, R01MH058356, R01MH069618
Study First Received: July 6, 2005
Results First Received: December 12, 2013
Last Updated: May 13, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Texas Southwestern Medical Center:
Cognitive therapy
Antidepressants
Psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014