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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Iowa
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carolyn L Turvey, University of Iowa
ClinicalTrials.gov Identifier:
NCT01337726
First received: March 24, 2011
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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 Intervention
Depression
Heart Failure
Chronic Obstructive Pulmonary Disease
Behavioral: Combined Psychotherapy and Illness Management
Behavioral: Illness Management Only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Illness Management and Psychotherapy in Treating Depressed Elders

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Reduction in depressive symptoms [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    Change from Baseline in depressive symtoms at 10 weeks


Secondary Outcome Measures:
  • Improvement in quality of life/functioning [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    Change from Baseline in quality of life/functioning at 10 weeks


Estimated Enrollment: 216
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337726

Contacts
Contact: Dawn M Klein, MSW 319-353-5630 dawn-m-klein@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Carolyn L. Turvey, PhD         
Iowa City VA Health Care System Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Carolyn L. Turvey, PhD         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Carolyn L. Turvey, PhD University of Iowa
  More Information

No publications provided

Responsible Party: Carolyn L Turvey, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01337726     History of Changes
Other Study ID Numbers: R01MH086482, R01MH086482
Study First Received: March 24, 2011
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 18, 2014