Stepped Care for Depression in Heart Failure

Overview

This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart failure self-care education and support. The primary aims are to determine whether stepped care is superior to usual care for depression, and whether treating depression improves heart failure self-care outcomes.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2021

Detailed Description

Depression is associated with poor heart failure self-care. Good self-care practices, including following dietary recommendations, taking prescribed medications, monitoring symptoms, and regular light exercise have been shown to improve quality of life and survival in persons with heart failure.

Both CBT and antidepressant medications have been used in previous studies to treat major depression in patients with heart failure. Participants in the intervention arm in this trial will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT may also be referred to their own physician to discuss antidepressant medications.

Heart failure self-care education and support will be provided after the first 8 weeks of the depression intervention. The study will determine whether people with heart failure benefit more from self-care education and support after their depression has been treated with a stepped care intervention, as compared to usual care for depression as provided by primary care providers.

Interventions

  • Behavioral: Stepped care for depression
    • Cognitive behavior therapy (CBT), plus referral to the participant’s own physician to discuss antidepressant medications if indicated.

Arms, Groups and Cohorts

  • Experimental: Stepped Care for Depression
    • Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support.
  • No Intervention: Enhanced Usual Care
    • Participants will receive individually-tailored heart failure self-care education and support. With the participant’s permission, his or her personal physician will be notified about the patient’s depression. The participant will be asked to discuss depression treatment options with his or her personal physician.

Clinical Trial Outcome Measures

Primary Measures

  • Beck Depression Inventory (BDI-II) total score
    • Time Frame: 16 weeks
    • Self-reported severity of depression
  • Self Care of Heart Failure Index (SCHFI) Maintenance subscale
    • Time Frame: 16 weeks
    • Self-reported heart failure self-care behaviors

Secondary Measures

  • Beck Anxiety Inventory
    • Time Frame: 16 weeks
    • Self-reported severity of anxiety symptoms
  • Kansas City Cardiomyopathy Questionnaire (KCCQ)
    • Time Frame: 16 weeks
    • Heart failure-related quality of life
  • Hamilton Rating Scale for Depression (HAM-D-17)
    • Time Frame: 16 weeks
    • Interviewer-rated severity of depression symptoms
  • Actigraphy
    • Time Frame: 16 weeks
    • Physical activity level

Participating in This Clinical Trial

Inclusion Criteria

1. Stable, clinically-documented Class I-III heart failure.

2. Current major depressive episode.

3. Baseline BDI-II score 14 or greater

Exclusion Criteria

1. Dementia or other significant cognitive or communication deficits

2. Terminal illness other than HF

3. Insurmountable logistical barriers to participation

4. Age less than 25 years

5. Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder

6. High risk of suicide

7. Current participation in non-study psychotherapy for depression or other psychiatric conditions

8. Initiation or modification of antidepressant medication treatment within past two months

9. Renal or hepatic conditions that would preclude the use of antidepressants.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kenneth E Freedland, PhD, Principal Investigator, Washington University School of Medicine
  • Overall Contact(s)
    • Judith A Skala, PhD, RN, 314-286-1316, skalaj@wustl.edu

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