Combined Illness Management and Psychotherapy in Treating Depressed Elders

Depression Clinical Trial

— COPE  

Official title:

Combined Illness Management and Psychotherapy in Treating Depressed Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337726
• Other study ID #: R01MH086482
• Secondary ID: R01MH086482
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: April 4, 2017
• Start date: February 2011
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Depression
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System	Iowa City	Iowa
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in depressive symptoms	Change from Baseline in depressive symtoms at 10 weeks	10 weeks
Secondary	Improvement in quality of life/functioning	Change from Baseline in quality of life/functioning at 10 weeks	10 weeks