Cognitive Therapy for Treating Depression and Preventing Relapse

Depression Clinical Trial

Official title:

Prophylactic Cognitive Therapy for Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00183664
• Other study ID #: R01MH058356
• Secondary ID: DSIR 83-ATP
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: March 16, 2009
• Start date: December 1999
• Est. completion date: June 2011

Study information

• Verified date: March 2009
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 523
• Est. completion date: June 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Fluoxetine
Fluoxetine 10 to 40 mg/day for 8 months

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.

Drug:
• Placebo
Placebo daily for 8 months

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Thase ME, Friedman ES, Berman SR, Fasiczka AL, Lis JA, Howland RH, Simons AD. Is cognitive behavior therapy just a 'nonspecific' intervention for depression? A retrospective comparison of consecutive cohorts treated with cognitive behavior therapy or supportive counseling and pill placebo. J Affect Disord. 2000 Jan-Mar;57(1-3):63-71. — View Citation

Thase ME, Friedman ES, Fasiczka AL, Berman SR, Frank E, Nofzinger EA, Reynolds CF 3rd. Treatment of men with major depression: a comparison of sequential cohorts treated with either cognitive-behavioral therapy or newer generation antidepressants. J Clin Psychiatry. 2000 Jul;61(7):466-72. — View Citation

Thase ME, Friedman ES. Is psychotherapy an effective treatment for melancholia and other severe depressive states? J Affect Disord. 1999 Jul;54(1-2):1-19. Review. — View Citation

Thase ME. How should efficacy be evaluated in randomized clinical trials of treatments for depression? J Clin Psychiatry. 1999;60 Suppl 4:23-31; discussion 32. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive relapse		Measured at Month 9	No
Secondary	Psychosocial functioning		Measured at Month 9	No