Depression and Self-care in Heart Failure (DASH)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01028625
First received: December 4, 2009
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Heart Failure
Depression
Behavioral: Cognitive Behavior Therapy
Other: Heart Failure Self-care Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • BDI-II score at 6 months [ Time Frame: Baseline, 3 months, 6 months, 9 months , 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-care of Heart Failure Index [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Medical outcomes study SF-12 [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • PROMIS Physical Functioning Scale [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Kansas City Cardiomyopathy Questionnaires [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • 6 Minute Walk Test [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Depression Interview and Structured Hamilton (DISH) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: January 2010
Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: HFE
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 Name: HFE

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028625

Locations
United States, Missouri
Washington University School of Medicine Behavioral Medicine Center
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kenneth E. Freedland, Ph.D. Washington University School of Medicine Behavioral Medicine Center
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01028625     History of Changes
Other Study ID Numbers: 201013037, 1R01HL091918
Study First Received: December 4, 2009
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Heart failure
Depression
Self Care
Cognitive behavior therapy

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

ClinicalTrials.gov processed this record on July 24, 2014