|
CBASP is currently being tested in a four-year (2002-2006)
National Institute of Mental Health (NIMH) 9-site investigation, “CBASP
Augmentation for Treatment of Chronic Depression.” The
study will continue two additional years with a naturalistic
follow-up phase. The multi-site study involves the Department
of Psychiatry at University
of
Arizona (Principal
Investigator:
Alan
J. Gelenberg, M.D.); Department of Psychiatry, Brown University
(PI: Martin B. Keller, M.D.); Department of Psychiatry,
Cornell University Medical College (PI: James H. Kocsis,
M.D.); Department of Psychiatry, Emory University School
of Medicine (PI: Philip T. Ninan, M.D.); Department of
Psychology, State University of New York at Stony Brook
(PI: Daniel N. Klein, PhD); University of Texas Southwestern
Medical Center at Dallas (PI: Madhukar H. Trivedi); Department
of Psychology, Virginia Commonwealth University (PI: James.
P. McCullough, Jr., PhD); Department of Psychiatry, University
of Stanford Medical School (PI: Alan F. Schatzberg, M.D.);
and Western Psychiatric Institute and Clinic, University
of Pittsburgh (PI: Michael E. Thase, M.D.).
Eight-hundred and fifty chronically depressed outpatients
will be enrolled into a Phase I medication-only cell for
12 weeks. At the end of the 3 months period, Full Responders
will continue to receive medication for another 12 weeks.
Partial and Non-Responders will be randomized into Phase
II of the study, which last 12 weeks. Non-responders will
be switched to another medication and partial responders
will receive augmentation medication. In addition, patients
will be assigned in a 2:2:1 ratio to receive CBASP psychotherapy,
Brief Supportive Psychotherapy (BSP), or Medication Alone.
The BSP therapy model is a non-directive type of psychotherapy
developed by Dr. John C. Markowitz,
Research Psychiatrist at the New York State Psychiatric Institute and a Clinical Professor of Psychiatry at the Weill Medical College of Cornell University.
Phase I of the study mimics actual clinical practice
in that most patients who present for psychiatric treatment
and who are diagnosed with either an episodic/acute Major
Depression or Chronic Depression usually begin treatment
with an antidepressant drug. Patients who do not fully
respond will continue to receive medication but will often
have their treatment augmented by the addition of some
form of psychotherapy. Phase II of this study mirrors this
dimension of practice. CBASP, in addition to being tested
as an augmentation strategy for chronically depressed outpatients,
will be compared to a nonspecific psychotherapy model, Brief Supportive Psychotherapy (BSP). The problem-solving component of CBASP (Situational Analysis) will be compared to the nonspecific model to determine if the specific factor, problem solving coping, adds significantly to treatment outcome. The goal here is to determine
the degree to which the specific factor of CBASP (i.e.,
problem solving training) adds to treatment outcome over
and above nonspecific or common therapeutic factors.
This
NIMH study will be a landmark investigation in several
ways. One, the study is the largest randomized psychotherapy-medication
clinical trial for chronic depression ever conducted in either
psychology or psychiatry; two, its size will offer a significant
test of whether a specific theory-driven technique has significant effects on a common, non-specific factor, the therapeutic alliance; and third and most important, it
will test the efficacy of using CBASP as an augmentation
strategy for patients who do not respond fully to two state-of-the-art
antidepressant medications.
|