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

Depression Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01940237
• Other study ID #: 6397
• Status: Terminated
• Phase: N/A
• First received: August 28, 2013
• Last updated: May 18, 2017
• Start date: April 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Depression
• Depressive Disorder
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Psychotherapy
Interpersonal psychotherapy in the treatment of major depressive disorder.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

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