Stepped Care for Depression in Heart Failure (DASH-2)
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|ClinicalTrials.gov Identifier: NCT02997865|
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Depressive Disorder, Major||Behavioral: Stepped care for depression||Not Applicable|
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 given an FDA-approved antidepressant medication.
Heart failure self-care education and support will be provided after 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Stepped Care for Depression in Heart Failure|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Stepped Care for Depression
Participants will receive cognitive behavior therapy for depression, plus the addition of antidepressant medication if symptoms do not improve within 5-10 weeks. The study psychiatrist may choose between the following FDA-approved antidepressant medications: sertraline, escitalopram, bupropion extended release (XL), and mirtazapine. Participants will also receive individually-tailored heart failure self-care education and support
Behavioral: Stepped care for depression
Cognitive behavior therapy (CBT), augmented with an antidepressant 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.
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02997865
|Contact: Jeanne Heaghney, RNfirstname.lastname@example.org|
|Contact: Judith Skala, PhD, RNemail@example.com|
|United States, Missouri|
|Behavioral Medicine Center at WUSM||Recruiting|
|Saint Louis, Missouri, United States, 63108|
|Contact: Jeanne Heaghney, RN 314-286-1517 firstname.lastname@example.org|
|Contact: Judith Skala, RN, PhD 3142861316 email@example.com|
|Principal Investigator:||Kenneth Freedland, PhD||Washington Universtiy School of Medicine|
|Principal Investigator:||Robert Carney, PhD||Washington Universtiy School of Medicine|