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

April 4, 2017 updated by: Carolyn L Turvey, University of Iowa
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
      • Iowa City, Iowa, United States, 52242
        • Iowa City VA Health Care System

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.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in depressive symptoms
Time Frame: 10 weeks
Change from Baseline in depressive symtoms at 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in quality of life/functioning
Time Frame: 10 weeks
Change from Baseline in quality of life/functioning at 10 weeks
10 weeks

Collaborators and Investigators

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

Sponsor

University of Iowa

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Carolyn L. Turvey, PhD, University of Iowa

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 Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH086482 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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