Depression and Self-care in Heart Failure

Depression Clinical Trial

— DASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028625
• Other study ID #: 201013037
• Secondary ID: 1R01HL091918
• Status: Completed
• Phase: N/A
• First received: December 4, 2009
• Last updated: May 27, 2014
• Start date: January 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Heart Failure

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine Behavioral Medicine Center	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDI-II score at 6 months		Baseline, 3 months, 6 months, 9 months , 12 months	No
Secondary	Self-care of Heart Failure Index		Baseline, 3 months, 6 months, 9 months, 12 months	No
Secondary	Beck Anxiety Inventory		Baseline, 3 months, 6 months, 9 months, 12 months	No
Secondary	Medical outcomes study SF-12		Baseline, 3 months, 6 months, 9 months, 12 months	No
Secondary	PROMIS Physical Functioning Scale		Baseline, 6 months	No
Secondary	Kansas City Cardiomyopathy Questionnaires		Baseline, 3 months, 6 months, 9 months, 12 months	No
Secondary	6 Minute Walk Test		Baseline, 6 months	No
Secondary	Depression Interview and Structured Hamilton (DISH)		Baseline, 6 months	No