Back to resultsCombined Illness Management and Psychotherapy in Treating Depressed Elders (COPE)
Primary Purpose
Depression, Heart Failure, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Psychotherapy and Illness Management
Illness Management Only
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Heart Failure, Chronic Obstructive Pulmonary Disease, Quality of Life, Functional Impairment
Eligibility 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
Sites / Locations
- Iowa City VA Health Care System
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Illness Management Only
Combined Psychotherapy & Illness Management
Arm Description
Outcomes
Primary Outcome Measures
Reduction in depressive symptoms
Change from Baseline in depressive symtoms at 10 weeks
Secondary Outcome Measures
Improvement in quality of life/functioning
Change from Baseline in quality of life/functioning at 10 weeks
Full Information
NCT ID
NCT01337726
First Posted
March 24, 2011
Last Updated
April 4, 2017
Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01337726
Brief Title
Combined Illness Management and Psychotherapy in Treating Depressed Elders
Acronym
COPE
Official Title
Combined Illness Management and Psychotherapy in Treating Depressed Elders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Heart Failure, Chronic Obstructive Pulmonary Disease
Keywords
Depression, Heart Failure, Chronic Obstructive Pulmonary Disease, Quality of Life, Functional Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Illness Management Only
Arm Type
Active Comparator
Arm Title
Combined Psychotherapy & Illness Management
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Combined Psychotherapy and Illness Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Illness Management Only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in depressive symptoms
Description
Change from Baseline in depressive symtoms at 10 weeks
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Improvement in quality of life/functioning
Description
Change from Baseline in quality of life/functioning at 10 weeks
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn L. Turvey, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa City VA Health Care System
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combined Illness Management and Psychotherapy in Treating Depressed Elders
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