A Pilot Trial Of Interpersonal Psychotherapy For The Treatment Of Depression In Patients With Prostate, Colorectal, Lung And Pancreatic Cancer

Study Overview

A Pilot Trial of Interpersonal Psychotherapy for the Treatment of Depression in Patients With Prostate, Colorectal, Lung and Pancreatic Cancer

There is now overwhelming evidence documenting the efficacy of psychotherapy in the treatment of depression in the general population. Surprisingly, however, given the high prevalence of depression in cancer patients, there are very few studies on the efficacy of psychotherapy in this population. Published studies of psychotherapy in cancer patients generally include patients with high heterogeneity of psychiatric diagnosis and frequently include patients without a psychiatric diagnosis, with the aim of preventing the appearance of a psychiatric disorder. This heterogeneity complicates the interpretation of the efficacy and specificity of these interventions. Specifically, the efficacy of psychotherapy for major depression in patients with cancer is unknown.

Interpersonal psychotherapy (IPT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) in several controlled trials. This study will test the efficacy of IPT in a group of prostate, colorectal, lung and pancreatic cancer patients with a diagnosis of major depressive disorder. We will test the efficacy of IPT using a variety of outcome measures at different time points of the treatment. Those scales will evaluate the patient's depressive symptoms, psychosocial functioning and quality of life. Patients that are deemed eligible for the study will have IPT for twelve weeks. Patients will receive twelve 50-minute sessions over 16 weeks. To facilitate access to treatment, sessions 1,2,3,4, 8 and 12 will be in person, while all others will in be person or over the telephone according to the patient's choice. Sessions will be audiotaped and periodically reviewed by experienced supervisors to assess therapist's adherence to IPT technique. This taping will be optional and is covered in a separate consent form. This pilot study is to prove feasibility and acceptability of IPT in this population and to show preliminary efficacy.

Depression
Pancreatic Cancer
Lung Cancer
Colon Cancer
Prostate Cancer

BEHAVIORAL: Psychotherapy

6397

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-08-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-05-18
First Submitted that Met QC Criteria 2013-09-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-05-19
First Posted (ACTUAL) 2013-09-12	Results First Posted N/A	Last Verified 2017-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Interpersonal Psychotherapy (IPT) Interpersonal psychotherapy (IPT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) in several controlled trials. This study will test the efficacy of IPT in a group of prostate, colorectal, lung an	BEHAVIORAL: Psychotherapy Interpersonal psychotherapy in the treatment of major depressive disorder.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Interpersonal Psychotherapy (IPT)

BEHAVIORAL: Psychotherapy

Interpersonal psychotherapy in the treatment of major depressive disorder.

Primary Outcome Measures	Measure Description	Time Frame
Change in Hamilton Depression Scale (HAMD-17)	10 to 15 minutes of mood assessment.	baseline, and every fourth week till week 12.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

A primary psychiatric diagnosis of Major Depressive Disorder as defined by DSM-IV
Diagnosis of prostate, colorectal, lung or pancreatic cancer (stage 1-4)
A score of 16 or above in the 17-item HAM-D (Hamilton depression scale)
Male or female ages 18-75.
Ability to give consent
English and/ or Spanish Speaking

Lifetime history of psychosis or bipolar disorder
History of substance abuse or dependence in the three months prior to the study.
Current suicide risk.
Patients who have ever failed IPT in the context of cancer.
Patients who are receiving effective medication for depression
Patients with T3, T4 and THS abnormal values

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Carlos Blanco, MD, PhD, NYSPI - Columbia University Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record