A Pilot Trial of Interpersonal Psychotherapy for the Treatment of Depression in Patients With Prostate, Colorectal, Lung and Pancreatic Cancer
Primary Purpose
Depression, Pancreatic Cancer, Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Psychotherapy, Cancer, Pancreatic Cancer, Lung Cancer, Colon Cancer, Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interpersonal Psychotherapy (IPT)
Arm 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.
Outcomes
Primary Outcome Measures
Change in Hamilton Depression Scale (HAMD-17)
10 to 15 minutes of mood assessment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01940237
First Posted
August 28, 2013
Last Updated
May 18, 2017
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT01940237
Brief Title
A Pilot Trial of Interpersonal Psychotherapy for the Treatment of Depression in Patients With Prostate, Colorectal, Lung and Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Pancreatic Cancer, Lung Cancer, Colon Cancer, Prostate Cancer
Keywords
Depression, Psychotherapy, Cancer, Pancreatic Cancer, Lung Cancer, Colon Cancer, Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interpersonal Psychotherapy (IPT)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Interpersonal psychotherapy in the treatment of major depressive disorder.
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Scale (HAMD-17)
Description
10 to 15 minutes of mood assessment.
Time Frame
baseline, and every fourth week till week 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Blanco, MD, PhD
Organizational Affiliation
NYSPI - Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Trial of Interpersonal Psychotherapy for the Treatment of Depression in Patients With Prostate, Colorectal, Lung and Pancreatic Cancer
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