Depression and Self-care in Heart Failure (DASH)

May 27, 2014 updated by: Washington University School of Medicine

Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression

The purpose of the study is to test whether Cognitive Behavior Therapy (CBT) plus heart failure self-care education is superior to "usual care" for depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comorbid depression is common in heart failure, but little is known about how to treat it. This randomized, controlled, efficacy trial will compare cognitive behavior therapy (CBT) to usual care (UC) for depression in heart failure. CBT will be integrated with an intervention to improve heart failure self-care, because depression and inadequate self-care are thought to be interrelated problems. It will also be integrated with clinical attention to primary caregiver stress. Basic heart failure education will be provided to all participants.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Washington University School of Medicine Behavioral Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New York Heart Association Class I, II, or III Heart Failure (Clinically diagnosed at least 3 months ago)
  • Meets the DSM-IV criteria for a current major depressive episode, or for current minor depression with a past history of at least one major depressive episode.
  • PHQ-9 score of 10 or greater plus 2 or 3 on question 1 or 2 over the last 2 weeks including today

Exclusion Criteria:

  • Less than 30 years old
  • Current ETOH / drug abuse
  • Bipolar disorder, schizophrenia, or other psychotic disorder
  • Communication barrier
  • Dementia
  • Currently in competing research protocol
  • High risk for suicide
  • Insurmountable logistical barriers to laboratory assessment visits
  • Major mobility-limiting physical disability
  • Poor 1 year prognosis not r/t heart failure
  • Hospitalized for heart failure or acute coronary syndrome in last month
  • Initiated antidepressant therapy in the past 4 weeks
  • Current non-study psychotherapy for depression or other psychiatric problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Behavior Therapy
Behavioral: Cognitive Behavior Therapy
CBT utilizes a variety of strategies and techniques to modify cognitions and behaviors that contribute to depression such as behavioral activation; identifying and challenging distressing thoughts, beliefs, and attitudes; and systematic problem-solving. In this trial, CBT will be integrated with an intervention aimed at improving heart failure self-care, and with attention to primary caregiver stress. The CBT sessions will usually last about 50 minutes and will be scheduled weekly for up to 6 months, with additional maintenance contacts after that. The frequency of sessions will be tapered prior to 6 months if the participant meets the study criteria for depression remission and has acquired relapse-prevention skills.
Other Names:
  • CBT
Other: Heart Failure Self-care Education
Participants in both arms will receive heart failure educational material from the Heart Failure Society of America. In addition, a RN will review educational material with participants during baseline visit and with 3 weekly follow up phone calls.
Other Names:
  • HFE
Other: Usual Care
Participants who are randomly assigned to usual care will receive whatever treatment (if any) for depression their own physician may prescribe. In most cases, treatment (if any is provided) is likely to consist of a serotonin reuptake inhibitor (SSRI) antidepressant such as sertraline or citalopram.
Other: Heart Failure Self-care Education
Participants in both arms will receive heart failure educational material from the Heart Failure Society of America. In addition, a RN will review educational material with participants during baseline visit and with 3 weekly follow up phone calls.
Other Names:
  • HFE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BDI-II score at 6 months
Time Frame: Baseline, 3 months, 6 months, 9 months , 12 months
Baseline, 3 months, 6 months, 9 months , 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-care of Heart Failure Index
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Baseline, 3 months, 6 months, 9 months, 12 months
Beck Anxiety Inventory
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Baseline, 3 months, 6 months, 9 months, 12 months
Medical outcomes study SF-12
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Baseline, 3 months, 6 months, 9 months, 12 months
PROMIS Physical Functioning Scale
Time Frame: Baseline, 6 months
Baseline, 6 months
Kansas City Cardiomyopathy Questionnaires
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Baseline, 3 months, 6 months, 9 months, 12 months
6 Minute Walk Test
Time Frame: Baseline, 6 months
Baseline, 6 months
Depression Interview and Structured Hamilton (DISH)
Time Frame: Baseline, 6 months
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Kenneth E. Freedland, Ph.D., Washington University School of Medicine Behavioral Medicine Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201013037
  • 1R01HL091918 (U.S. NIH Grant/Contract)

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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