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

December 4, 2009
May 27, 2014
January 2010
October 2013   (final data collection date for primary outcome measure)
BDI-II score at 6 months [ Time Frame: Baseline, 3 months, 6 months, 9 months , 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028625 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Depression and Self-care in Heart Failure
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Heart Failure
  • Depression
  • 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
  • Active Comparator: Cognitive Behavior Therapy
    Interventions:
    • Behavioral: Cognitive Behavior Therapy
    • Other: Heart Failure Self-care Education
  • 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.
    Intervention: Other: Heart Failure Self-care Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
April 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028625
201013037, 1R01HL091918
Yes
Washington University School of Medicine
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Kenneth E. Freedland, Ph.D. Washington University School of Medicine Behavioral Medicine Center
Washington University School of Medicine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP