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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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