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Completed

NCT Number: NCT01028625

Depression and Self-care in Heart Failure

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.

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Key information

Conditions

Heart Failure Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine Behavioral Medicine Center

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

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

Heart Failure Self-care Education

Other

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

Primary outcomes

  1. BDI-II score at 6 months

    Time frame: Baseline, 3 months, 6 months, 9 months , 12 months

Secondary outcomes

  1. Self-care of Heart Failure Index

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

  2. Beck Anxiety Inventory

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

  3. Medical outcomes study SF-12

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

  4. PROMIS Physical Functioning Scale

    Time frame: Baseline, 6 months

  5. Kansas City Cardiomyopathy Questionnaires

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

  6. 6 Minute Walk Test

    Time frame: Baseline, 6 months

  7. Depression Interview and Structured Hamilton (DISH)

    Time frame: Baseline, 6 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: DASH

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Dec 9, 2009
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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