Cognitive Therapy for Treating Depression and Preventing Relapse

This study has been terminated.
(Enrollment into acute phase therapy ended August 1st, 2008. Randomized continuation phase trial is slated to end in June 2009 and follow-up to end in June 2011.)
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183664
First received: September 13, 2005
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

This study will compare the effectiveness of cognitive therapy versus antidepressant medication in treating depression and preventing relapse in individuals with recurrent depression.


Condition Intervention Phase
Depression
Drug: Fluoxetine
Behavioral: Cognitive therapy (CT)
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Depressive relapse [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychosocial functioning [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]

Enrollment: 523
Study Start Date: December 1999
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive continuation phase cognitive therapy for a total of 11 months of treatment
Behavioral: Cognitive therapy (CT)
All participants will receive 16 to 20 individual sessions of CT for 3 months. Participants assigned to continuation phase will receive additional sessions every other week for 8 weeks and then monthly for 6 months.
Other Name: CBT
Active Comparator: 2
Participants will receive 3 months of cognitive therapy and then 8 months of treatment with the antidepressant fluoxetine hydrochloride
Drug: Fluoxetine
Fluoxetine 10 to 40 mg/day for 8 months
Other Name: Prozac
Behavioral: Cognitive therapy (CT)
All participants will receive 16 to 20 individual sessions of CT for 3 months. Participants assigned to continuation phase will receive additional sessions every other week for 8 weeks and then monthly for 6 months.
Other Name: CBT
Placebo Comparator: 3
Participants will receive 3 months of cognitive therapy and then 8 months of treatment with placebo capsules
Behavioral: Cognitive therapy (CT)
All participants will receive 16 to 20 individual sessions of CT for 3 months. Participants assigned to continuation phase will receive additional sessions every other week for 8 weeks and then monthly for 6 months.
Other Name: CBT
Drug: Placebo
Placebo daily for 8 months

Detailed Description:

Cognitive therapy (CT) is a form of therapy that focuses on changing negative thinking patterns and developing coping skills to deal with psychological problems. It encourages individuals to think, feel, and behave in a more positive manner. Previous research has shown that CT is effective for treating a number of psychological symptoms, including anxiety, anger, and loneliness. Many studies show that CT is, in fact, more effective than antidepressant medications for treating various psychological disorders. The "self-help" mentality and coping skills that are developed during CT tend to decrease the likelihood of depression relapse. While antidepressants often cause many unpleasant side effects such as dizziness, nausea, and increased heart rate, there are no known negative side effects associated with CT. The purpose of this study is to evaluate the effectiveness of CT versus antidepressant medication for treating depression and preventing relapse in individuals with recurrent depression.

This 36-month study will consist of three phases. During Months 1 through 3, participants will receive between 16 and 20 CT sessions. Participants will then be randomly assigned to receive additional CT sessions, antidepressant medication, or placebo for 8 months. Upon completing treatment, follow-up visits will occur once every 4 months for a total of 24 months. Outcome measurements will include standardized psychological tests and questionnaires to assess the participant's level of depression. All measurements will be assessed at Week 1, Week 12, and Months 8, 12, 16, 20, and 24.

  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
  • At least two episodes of major depression
  • At least one period of recovery during a depressive episode or a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
  • 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
  • Current 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 a medication that might cause depression
  • 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 6 weeks of 40 mg of Prozac
  • Pregnant or planning to become pregnant in the next 11-12 months
  • Unable to attend clinic twice weekly during business hours
  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: NCT00183664

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Investigators
Principal Investigator: Michael E. Thase, MD The University of Pittsburgh School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael E. Thase, University of Pennsylvania School of Medicine
ClinicalTrials.gov Identifier: NCT00183664     History of Changes
Other Study ID Numbers: R01 MH058356, DSIR 83-ATP
Study First Received: September 13, 2005
Last Updated: March 16, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Depression
Cognitive Therapy
Relapse Prevention

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 July 24, 2014