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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02997865|
Recruitment Status : Active, not recruiting
First Posted : December 20, 2016
Last Update Posted : May 13, 2021
|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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Stepped Care for Depression in Heart Failure|
|Actual Study Start Date :||February 17, 2017|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
- 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
|United States, Missouri|
|Behavioral Medicine Center at Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Kenneth E Freedland, PhD||Washington University School of Medicine|