Major Depression Clinical Trial
Official title:
Interpersonal Therapy for Depression in Breast Cancer
The investigators propose a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer and major depressive disorder (MDD).
Depressive symptoms and disorders are common in cancer patients: up to 58% have depressive
symptoms, and 38% meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition
(DSM-IV) criteria for major depressive disorder (MDD). Depression worsens over the course of
cancer treatment, persists long after cancer therapy, recurs with recurrence of cancer, and
negatively affects patients' adherence to cancer treatment, survival, symptom management,
psychosocial functioning, and quality of life. As surviving cancer becomes increasingly
common, there is an urgent need to establish an empirical basis for the provision of
evidence-based treatments to depressed cancer patients.We propose a randomized clinical trial
to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST),
and Brief Supportive Psychotherapy (BSP), in improving depressive symptoms, psychosocial
functioning, and quality of life among patients with breast cancer and major depressive
disorder. The study is based on several complementary observations from recent studies.
First, 30-60% of cancer patients experience clinically significant depressive symptoms.
Second, depression is associated with poorer cancer outcomes. Third, over the course of the
illness, depression recurs or persists for a significant number of cancer patients. Fourth,
several recent reviews have indicated that, despite decades of research and hundreds of
studies, the available evidence is insufficient to empirically guide the treatment of major
depressive disorder in cancer patients. This has led the national institute of health, the
Institute of Medicine, and other experts to call for well-designed, controlled trials of the
treatment of depression in cancer patients.
Interpersonal Psychotherapy is a brief, manualized therapy that has shown efficacy in
treating major depression in several controlled trials including a large trial for depressed
HIV-infected individuals and other randomized trials in depressed individuals with other
comorbid medical illnesses. Research shows that Interpersonal Psychotherapy improves social
skills and functioning. Interpersonal Psychotherapy has shown remarkable flexibility and
efficacy across age ranges, cultures, formats, and modes of delivery. We recently obtained
promising pilot data in a small open trial on the acceptability and efficacy of individual
Interpersonal Psychotherapy for depressed breast cancer patients of diverse ethnic
background, socioeconomic status, and cancer progression stage. Problem-Solving Therapy is a
brief, manualized form of cognitive-behavioral therapy (CBT) that has been adapted to treat
depression in cancer patients, and has shown highly promising results. Brief Supportive
Psychotherapy, a relatively unstructured psychotherapy commonly used in clinical practice,
focuses on the patient's affect. It builds a strong therapeutic alliance through careful,
empathic listening and validating and encouraging toleration of the patient's emotions. It
has shown promising results in depressed individuals with cancer and other medical illnesses.
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