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Completed

NCT Number: NCT00118404

Cognitive Therapy for Recurrent Depression

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuation phase cognitive therapy

Behavioral

Continuation phase cognitive therapy included 10 sessions over 8 months.

Continuation phase fluoxetine

Drug

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

Other names: Prozac

Continuation phase pill placebo

Other

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

Acute phase cognitive therapy

Behavioral

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

Primary outcomes

  1. 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:

    • = No residual symptoms, no current evidence of the disorder.
    • = Mild symptoms
    • = Considerably less psychopathology than full criteria with no more than moderate impairment
    • = Does not meet full criteria but has major symptoms of impairment
    • = Meets criteria without extreme impairment in functioning
    • = 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)

  2. 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:

    • = No residual symptoms, no current evidence of the disorder.
    • = Mild symptoms
    • = Considerably less psychopathology than full criteria with no more than moderate impairment
    • = Does not meet full criteria but has major symptoms of impairment
    • = Meets criteria without extreme impairment in functioning
    • = 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)

  3. 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:

    • = No residual symptoms, no current evidence of the disorder.
    • = Mild symptoms
    • = Considerably less psychopathology than full criteria with no more than moderate impairment
    • = Does not meet full criteria but has major symptoms of impairment
    • = Meets criteria without extreme impairment in functioning
    • = 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).

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Prophylactic Cognitive Therapy for Depression.

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2005
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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