Cognitive Therapy for Treating Depression and Preventing Relapse

Condition(s) targeted: Depression

Intervention: Fluoxetine (Drug); Cognitive therapy (CT) (Behavioral); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Michael E. Thase, MD, Principal Investigator, Affiliation: The University of Pittsburgh School of Medicine

Overall contact:
Marna S. Barnett, PhD, Phone: 215-746-6680, Email: msb@mail.med.upenn.edu

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

Official title: Prophylactic Cognitive Therapy for Depression

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Depressive relapse

Secondary outcome: Psychosocial functioning

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Marna S. Barnett, PhD, Phone: 215-746-6680, Email: msb@mail.med.upenn.edu

University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Judith A. Callan, RN, MSN, Phone: 412-246-5734, Email: callanja@upmc.edu
Lisa M. Stupar, Phone: 412-246-5757, Email: stuparlm@upmc.edu
Michael E. Thase, MD, Principal Investigator
Edward S. Friedman, MD, Sub-Investigator

Related publications:

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.

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.

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.

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.

Starting date: December 1999
Ending date: December 2012
Last updated: February 12, 2008