Clinical trial NCT01191580: Interpersonal Therapy for Depression in Breast Cancer
Official title: Interpersonal Therapy for Depression in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2010-08-31
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* A primary psychiatric diagnosis of Major Depressive Disorder as defined by: a score of 18 or above in the 17-item Hamilton Depression Scale; Male or female ages 18+;
* Ability to give consent
* Diagnosis of Breast Cancer
* Patients may be either English or Spanish speaking

Exclusion Criteria:

* Lifetime history of psychosis or bipolar disorder
* Patients meeting diagnostic statistic manual for mental disorder criteria for alcohol or substance use disorders who require acute detoxification.
* Current suicide risk.
* Advanced cancer or other condition that limits remaining life expectancy to less than 6 months.
* Patients who are receiving effective medication for Depression

Primary outcomes:
measure: Hamilton Depression Scale (HAMD-17)
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI
name: John C. Markowitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: