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

NCT01940237 | Terminated DMC

• 1 other identifier: 6397
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Pancreatic Cancer; Lung Cancer; Colon Cancer; Prostate Cancer

Keywords

Depression; Psychotherapy; Cancer; Pancreatic Cancer; Lung Cancer; Colon Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Scale (HAMD-17)

  10 to 15 minutes of mood assessment.

  baseline, and every fourth week till week 12.

Study Arms (1)

Interpersonal Psychotherapy (IPT)

EXPERIMENTAL

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.

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

Interpersonal psychotherapy in the treatment of major depressive disorder.

Interpersonal Psychotherapy (IPT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Pancreatic Neoplasms; Lung Neoplasms; Colonic Neoplasms; Prostatic Neoplasms; Neoplasms

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Carlos Blanco, MD, PhD

  NYSPI - Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 12, 2013
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

US (1)