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

September 13, 2005
March 16, 2009
December 1999
June 2009   (final data collection date for primary outcome measure)
Depressive relapse [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
Depressive relapse; measured at Week 12, Months 8, 12, 16, 20, and 24
Complete list of historical versions of study NCT00183664 on ClinicalTrials.gov Archive Site
Psychosocial functioning [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
Psychosocial functioning; measured at Week 12, Months 8, 12, 16, 20, and 24
Not Provided
Not Provided
 
Cognitive Therapy for Treating Depression and Preventing Relapse
Prophylactic Cognitive Therapy for Depression

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Depression
  • 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
  • Drug: Placebo
    Placebo daily for 8 months
  • Experimental: 1
    Participants will receive continuation phase cognitive therapy for a total of 11 months of treatment
    Intervention: Behavioral: Cognitive therapy (CT)
  • Active Comparator: 2
    Participants will receive 3 months of cognitive therapy and then 8 months of treatment with the antidepressant fluoxetine hydrochloride
    Interventions:
    • Drug: Fluoxetine
    • Behavioral: Cognitive therapy (CT)
  • Placebo Comparator: 3
    Participants will receive 3 months of cognitive therapy and then 8 months of treatment with placebo capsules
    Interventions:
    • Behavioral: Cognitive therapy (CT)
    • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
523
June 2011
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183664
R01 MH058356, DSIR 83-ATP
Yes
Michael E. Thase, University of Pennsylvania School of Medicine
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Michael E. Thase, MD The University of Pittsburgh School of Medicine
National Institute of Mental Health (NIMH)
March 2009

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