We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Illness Management and Psychotherapy in Treating Depressed Elders (COPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01337726
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations.

Condition or disease Intervention/treatment
Depression Heart Failure Chronic Obstructive Pulmonary Disease Behavioral: Combined Psychotherapy and Illness Management Behavioral: Illness Management Only

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Illness Management and Psychotherapy in Treating Depressed Elders
Study Start Date : February 2011
Primary Completion Date : March 2016
Study Completion Date : October 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Illness Management Only Behavioral: Illness Management Only
Participants in this group will have 10 weekly sessions with a study clinician at home and by phone. They will focus only on how they manage their illness. Follow up assessments will occur at 26 and 52 weeks.
Experimental: Combined Psychotherapy & Illness Management Behavioral: Combined Psychotherapy and Illness Management
Participants will have 10 weekly visits with a study clinician at their home and by phone. They will focus on their self care and illness management as well as how to manage their mood/cope emotionally. Follow up assessments will occur at 26 and 52 weeks.


Outcome Measures

Primary Outcome Measures :
  1. Reduction in depressive symptoms [ Time Frame: 10 weeks ]
    Change from Baseline in depressive symtoms at 10 weeks


Secondary Outcome Measures :
  1. Improvement in quality of life/functioning [ Time Frame: 10 weeks ]
    Change from Baseline in quality of life/functioning at 10 weeks


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 55 years or older
  • Diagnosis of Heart Failure or COPD
  • Depressive symptoms indicated by a BDI-II score of 10 or higher
  • Functional impairment

Exclusion Criteria:

  • Current psychotherapy
  • Cognitive Impairment
  • Psychiatric diagnosis
  • Active suicidal thoughts
  • Significant vision or hearing impairment
  • Residence in long term care facility
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337726


Locations
United States, Iowa
Iowa City VA Health Care System
Iowa City, Iowa, United States, 52242
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Carolyn L. Turvey, PhD University of Iowa
More Information

Responsible Party: Carolyn L Turvey, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01337726     History of Changes
Other Study ID Numbers: R01MH086482 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: May 2016

Keywords provided by Carolyn L Turvey, University of Iowa:
Depression
Heart Failure
Chronic Obstructive Pulmonary Disease
Quality of Life
Functional Impairment

Additional relevant MeSH terms:
Depression
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases