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Interpersonal Therapy for Depression in Breast Cancer


Phase 4
18 Years
90 Years
Open (Enrolling)
Both
Major Depression

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Trial Information

Interpersonal Therapy for Depression in Breast Cancer


Depressive symptoms and disorders are common in cancer patients: up to 58% have depressive
symptoms, and 38% meet 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Hamilton Depression Scale (HAMD-17)

Outcome Time Frame:

baseline

Safety Issue:

No

Principal Investigator

Carlos Blanco, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYSPI

Authority:

United States: Institutional Review Board

Study ID:

#5996

NCT ID:

NCT01191580

Start Date:

September 2009

Completion Date:

November 2014

Related Keywords:

  • Major Depression
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Depressive Disorder, Major

Name

Location

New York State Psychiatric Institute New York, New York  10033