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Stepped Care for Depression in Heart Failure (DASH-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02997865
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : March 19, 2019
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Depressive Disorder, Major Behavioral: Stepped care for depression Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stepped Care for Depression in Heart Failure
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.
Behavioral: Stepped care for depression
Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.

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.

Primary Outcome Measures :
  1. Beck Depression Inventory (BDI-II) total score [ Time Frame: 16 weeks ]
    Self-reported severity of depression

  2. Self Care of Heart Failure Index (SCHFI) Maintenance subscale [ Time Frame: 16 weeks ]
    Self-reported heart failure self-care behaviors

Secondary Outcome Measures :
  1. Beck Anxiety Inventory [ Time Frame: 16 weeks ]
    Self-reported severity of anxiety symptoms

  2. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 16 weeks ]
    Heart failure-related quality of life

  3. Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: 16 weeks ]
    Interviewer-rated severity of depression symptoms

  4. Actigraphy [ Time Frame: 16 weeks ]
    Physical activity level

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02997865

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Contact: Judith A Skala, PhD, RN 314-286-1316
Contact: Kenneth E Freedland, PhD 314-286-1311

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United States, Missouri
Behavioral Medicine Center at Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Jeanne Heaghney, RN    314-286-1517   
Contact: Judith Skala, RN, PhD    3142861316   
Sponsors and Collaborators
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Kenneth E Freedland, PhD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine Identifier: NCT02997865    
Other Study ID Numbers: R01HL131524 ( U.S. NIH Grant/Contract )
R01HL131524 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We may share de-identified data with other researchers after the completion of the study; no specific plans for this have been made yet.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
heart failure
depressive disorder, major
cognitive therapy
Additional relevant MeSH terms:
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Heart Failure
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Heart Diseases
Cardiovascular Diseases
Mood Disorders
Mental Disorders