Cognitive Therapy for Recurrent Depression

Condition(s) targeted: Depression

Intervention: Continuation phase cognitive therapy (Behavioral); Continuation phase fluoxetine (Drug); Continuation phase pill placebo (Other); Initial phase cognitive therapy (Behavioral)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Robin B. Jarrett, PhD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center at Dallas

This study will determine the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

Official title: Prophylactic Cognitive Therapy for Depression.

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

Primary outcome: Depressive relapse

Secondary outcome: Psychosocial functioning

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 will last approximately 36 months and will comprise three phases. For the first 12 weeks, all participants will receive between 16 and 20 CT sessions. Participants will then be randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants will have follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires will be used to assess depressive symptoms of participants at study start and at the end of each study phase.

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

Criteria:

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

University of Pittsburgh Medical Center Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Susan Berman, MS, Phone: 412-246-5731, Email: bermansr@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

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390, United States; Recruiting
Shelley J. Guess, BA, Phone: 214-648-5351
Robin B. Jarrett, PhD, Principal Investigator

Psychosocial Research and Depression Clinic

Related publications:

Hollon SD, Jarrett RB, Nierenberg AA, Thase ME, Trivedi M, Rush AJ. Psychotherapy and medication in the treatment of adult and geriatric depression: which monotherapy or combined treatment? J Clin Psychiatry. 2005 Apr;66(4):455-68. Review.

Jarrett RB, Kraft D, Doyle J, Foster BM, Eaves GG, Silver PC. Preventing recurrent depression using cognitive therapy with and without a continuation phase: a randomized clinical trial. Arch Gen Psychiatry. 2001 Apr;58(4):381-8.

Jarrett RB, Schaffer M, McIntire D, Witt-Browder A, Kraft D, Risser RC. Treatment of atypical depression with cognitive therapy or phenelzine Arch Gen Psychiatry. 2000 Nov;57(11):1084. No abstract available.

Starting date: December 1999
Ending date: May 2012
Last updated: March 4, 2008