Cognitive Therapy for Recurrent Depression

May 13, 2014 updated by: Robin Jarrett, University of Texas Southwestern Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

523

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Acute phase cognitive therapy
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Other: Continuation phase pill placebo
The dosage of pill placebo was increased to 40 mg over 8 months.
Active Comparator: 3
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Behavioral: Acute phase cognitive therapy
For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Drug: Continuation phase fluoxetine
The dosage of fluoxetine was increased to 40 mg over 8 months.
Other Names:
  • Prozac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Measured at month 8
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)
Measured at month 20
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).
Measured at month 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Robin B. Jarrett, PhD, University of Texas, Southwestern Medical Center at Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 6, 2005

First Submitted That Met QC Criteria

July 6, 2005

First Posted (Estimate)

July 11, 2005

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH058397 (U.S. NIH Grant/Contract)
  • R01MH069619 (U.S. NIH Grant/Contract)
  • R01MH058356 (U.S. NIH Grant/Contract)
  • R01MH069618 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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