- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00321269
Depression and Congestive Heart Failure in Outpatients.
Depression and CHF in Outpatients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Between 4 and 5% of patients seen at Veterans Affairs Medical Centers suffer heart failure. HF is the number one discharge diagnosis within the VHA. One of the most significant comorbidities in heart failure is depression. Depression predicts increased hospitalization and mortality even after controlling for key prognostic indicators. This HSR&D study aimed to test the effectiveness of a psychotherapy intervention for depression combined with illness management to illness management alone in veterans with heart failure.
Objectives:
To demonstrate better depression, health-related quality-of-life, and adherence outcomes for an illness management combined with psychotherapy intervention (COMBO) as compared to an illness management alone program (IMO).
Methods:
This was a two-site, two-arm, randomized controlled trial comparing COMBO to IMO. The total number of patients recruited for the study was 148. Retention was comparable between groups, though depression severity predicted drop out in the IMO condition but not the COMBO condition. Patients completed study assessments at baseline, week 4, week 8 (post-intervention) and at 26- and 52-week follow-up.
Status:
The main study analyses have been conducted. The project team is conducting analysis of secondary hypotheses
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
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Iowa City, Iowa, United States, 52246
- Iowa City VA Medical Center
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Missouri
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Columbia, Missouri, United States, 65201-5297
- Harry S. Truman Memorial VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Receiving treatment for NYHA Class 2-4 heart failure.
- Patients of the Iowa City, IA or Columbia, MO Veterans Affairs Medical Center Primary Care or Cardiac Care Clinics.
- Life expectancy greater than 6 months.
- Must speak English.
- Must possess a working telephone.
Exclusion Criteria:
- Presence of major psychiatric illness such as schizophrenia, bipolar disorder and substance abuse (PTSD patients are eligible).
- Life expectancy less than 3 months.
- Planned relocation to a nursing home.
- Marked visual or hearing impairment.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Single Illness Managment
This intervention includes standard disease self-management coaching for heart failure and helps patients set goals for fluid management, restricted salt-intake, and medication adherence.
|
8 week nursing intervention addressing Congestive Heart Failure
|
Experimental: Comorbid Illness Management
This intervention includes the same self-management coaching found in the comparator arm, but also includes discussion of ways to cope and manage mood.
|
8 week nursing intervention to address Congestive Heart Failure and emotional coping
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory II
Time Frame: Depression and psychological health will be assessed at week 1, week 8
|
Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63.
Higher scores indicate greater depression.
Effectiveness of treatment indicated by a decline in the BDI-II score.
|
Depression and psychological health will be assessed at week 1, week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-Related Quality of Life
Time Frame: Measured at week 1, week 8
|
Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.
|
Measured at week 1, week 8
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carolyn L Turvey, PhD MS, VA Medical Center, Iowa City
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 06-082
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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