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.|
|ClinicalTrials.gov Identifier: NCT00321269|
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : October 21, 2015
Last Update Posted : December 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Depression||Behavioral: Single Illness Management Behavioral: Comorbid Illness Management||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|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|
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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00321269
|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|
|Principal Investigator:||Carolyn L Turvey, PhD MS||VA Medical Center, Iowa City|