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Trial record 35 of 228 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Depression and Congestive Heart Failure in Outpatients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00321269
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : October 21, 2015
Last Update Posted : December 24, 2015
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Patients with a diagnosis of CHF, NYHA class II, III or IV will be recruited for a study comparing a nursing intervention addressing CHF (SIM group) or CHF and depression (CIM group). Participants in the standard illness management program will receive an 8-week, 8-session intervention designed to help them improve daily weighing, salt-restriction, medication management, etc. This intervention will be conducted in a combination of home visits and phone visits. They will also receive interactive, telephone-based daily monitoring that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the comorbid illness management program will receive the same illness management program PLUS education and behavioral techniques designed to help them cope emotionally with the illness. The comorbid illness management home monitoring will include a twice-monthly screen for depression. Major Variables: The major outcomes will be depressive symptoms, health-related quality of life, functional status, heart failure symptom severity, and self-care behaviors in heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Depression Behavioral: Single Illness Management Behavioral: Comorbid Illness Management Not Applicable

Detailed Description:


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.


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).


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.


The main study analyses have been conducted. The project team is conducting analysis of secondary hypotheses

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Depression and CHF in Outpatients
Study Start Date : October 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.
Behavioral: Single Illness Management
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.
Behavioral: Comorbid Illness Management
8 week nursing intervention to address Congestive Heart Failure and emotional coping

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00321269

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United States, Iowa
Iowa City VA Medical Center
Iowa City, Iowa, United States, 52246
United States, Missouri
Harry S. Truman Memorial VA Medical Center
Columbia, Missouri, United States, 65201-5297
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Carolyn L Turvey, PhD MS VA Medical Center, Iowa City

Publications of Results:
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Responsible Party: VA Office of Research and Development Identifier: NCT00321269     History of Changes
Other Study ID Numbers: IIR 06-082
First Posted: May 3, 2006    Key Record Dates
Results First Posted: October 21, 2015
Last Update Posted: December 24, 2015
Last Verified: November 2015

Keywords provided by VA Office of Research and Development:
Home Monitoring
Heart Failure

Additional relevant MeSH terms:
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Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases