OBJECTIVES: Heart Failure is a chronic syndrome affecting over 5.7 million in the US and 26 million adults worldwide with nearly 50% experiencing depressive symptoms. The objective of the study is to compare the effects of two evidence-based treatment options for adult patients with depression and advanced heart failure, on depressive symptom severity, physical and mental health relatedquality of life (HRQoL), heart-failure specific quality of life, caregiver burden, morbidity, and mortality at 3, 6 and 12-months. METHODS: Trial design. Pragmatic, randomized, comparative effectiveness trial. Interventions. The treatment interventions are: (1) Behavioral Activation (BA), a patient-centered psychotherapy which emphasizes engagement in enjoyable and valued personalized activities as selected by the patient; or (2) Antidepressant Medication Management administered using the collaborative care model (MEDS). Participants. Adults aged 18 and over with advanced heart failure (defined as New York Heart Association (NYHA) Class II, III, and IV) and depression (defined as a score of 10 or above on the PHQ-9 and confirmed by the MINI International Neuropsychiatric Interview for the DSM-5) selected from all patients at Cedars-Sinai Medical Center who are admitted with heart failure and all patients presenting to the outpatient programs of the Smidt Heart Institute at Cedars-Sinai Medical Center. We plan to randomize 416 patients to BA or MEDS, with an estimated 28% loss to follow-up/inability to collect follow-up data. Thus, we plan to include 150 in each group for a total of 300 participants from which data after randomization will be collected and analyzed. CONCLUSIONS: The current trial is the first to compare the impact of BA and MEDS on depressive symptoms, quality of life, caregiver burden, morbidity, and mortality in patients with depression and advanced heart failure. The trial will provide novel results that will be disseminated and implemented into a wide range of current practice settings. REGISTRATION: ClinicalTrials.Gov Identifier: NCT03688100.
RCT Entities:
OBJECTIVES:Heart Failure is a chronic syndrome affecting over 5.7 million in the US and 26 million adults worldwide with nearly 50% experiencing depressive symptoms. The objective of the study is to compare the effects of two evidence-based treatment options for adult patients with depression and advanced heart failure, on depressive symptom severity, physical and mental health related quality of life (HRQoL), heart-failure specific quality of life, caregiver burden, morbidity, and mortality at 3, 6 and 12-months. METHODS: Trial design. Pragmatic, randomized, comparative effectiveness trial. Interventions. The treatment interventions are: (1) Behavioral Activation (BA), a patient-centered psychotherapy which emphasizes engagement in enjoyable and valued personalized activities as selected by the patient; or (2) Antidepressant Medication Management administered using the collaborative care model (MEDS). Participants. Adults aged 18 and over with advanced heart failure (defined as New York Heart Association (NYHA) Class II, III, and IV) and depression (defined as a score of 10 or above on the PHQ-9 and confirmed by the MINI International Neuropsychiatric Interview for the DSM-5) selected from all patients at Cedars-Sinai Medical Center who are admitted with heart failure and all patients presenting to the outpatient programs of the Smidt Heart Institute at Cedars-Sinai Medical Center. We plan to randomize 416 patients to BA or MEDS, with an estimated 28% loss to follow-up/inability to collect follow-up data. Thus, we plan to include 150 in each group for a total of 300 participants from which data after randomization will be collected and analyzed. CONCLUSIONS: The current trial is the first to compare the impact of BA and MEDS on depressive symptoms, quality of life, caregiver burden, morbidity, and mortality in patients with depression and advanced heart failure. The trial will provide novel results that will be disseminated and implemented into a wide range of current practice settings. REGISTRATION: ClinicalTrials.Gov Identifier: NCT03688100.
Authors: Christopher M O'Connor; Wei Jiang; Maragatha Kuchibhatla; Susan G Silva; Michael S Cuffe; Dwayne D Callwood; Bosh Zakhary; Wendy Gattis Stough; Rebekka M Arias; Sarah K Rivelli; Ranga Krishnan Journal: J Am Coll Cardiol Date: 2010-08-24 Impact factor: 24.094
Authors: David V Sheehan; Kathy H Sheehan; R Douglas Shytle; Juris Janavs; Yvonne Bannon; Jamison E Rogers; Karen M Milo; Saundra L Stock; Berney Wilkinson Journal: J Clin Psychiatry Date: 2010-03 Impact factor: 4.384
Authors: Michael K Ong; Patrick S Romano; Sarah Edgington; Harriet U Aronow; Andrew D Auerbach; Jeanne T Black; Teresa De Marco; Jose J Escarce; Lorraine S Evangelista; Barbara Hanna; Theodore G Ganiats; Barry H Greenberg; Sheldon Greenfield; Sherrie H Kaplan; Asher Kimchi; Honghu Liu; Dawn Lombardo; Carol M Mangione; Bahman Sadeghi; Banafsheh Sadeghi; Majid Sarrafzadeh; Kathleen Tong; Gregg C Fonarow Journal: JAMA Intern Med Date: 2016-03 Impact factor: 21.873
Authors: Jeff C Huffman; Carol A Mastromauro; Gillian Sowden; Gregory L Fricchione; Brian C Healy; James L Januzzi Journal: Circ Cardiovasc Qual Outcomes Date: 2011-03-08
Authors: Stephen S Gottlieb; Meenakshi Khatta; Erika Friedmann; Lynn Einbinder; Scott Katzen; Brian Baker; Joanne Marshall; Stacey Minshall; Shawn Robinson; Michael L Fisher; Matthew Potenza; Brianne Sigler; Carissa Baldwin; Sue Ann Thomas Journal: J Am Coll Cardiol Date: 2004-05-05 Impact factor: 24.094