Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2021
2021
Historique:
received:
12
07
2020
accepted:
08
12
2020
entrez:
7
1
2021
pubmed:
8
1
2021
medline:
24
4
2021
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.Gov Identifier: NCT03688100.
Identifiants
pubmed: 33412562
doi: 10.1371/journal.pone.0244453
pii: PONE-D-20-20277
pmc: PMC7790529
doi:
Substances chimiques
Antidepressive Agents
0
Banques de données
ClinicalTrials.gov
['NCT03688100']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0244453Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):198-205
pubmed: 21386067
J Clin Psychiatry. 2010 Mar;71(3):313-26
pubmed: 20331933
J Am Coll Cardiol. 2010 Aug 24;56(9):692-9
pubmed: 20723799
Clin Psychol Rev. 2007 Apr;27(3):318-26
pubmed: 17184887
Arch Intern Med. 2001 Jul 23;161(14):1725-30
pubmed: 11485505
JAMA Intern Med. 2016 Mar;176(3):310-8
pubmed: 26857383
J Am Coll Cardiol. 2004 May 5;43(9):1542-9
pubmed: 15120809
Dialogues Clin Neurosci. 2011;13(1):7-23
pubmed: 21485743
Congest Heart Fail. 2003 May-Jun;9(3):163-9
pubmed: 12826775
Stat Methods Med Res. 2018 Jun;27(6):1634-1649
pubmed: 27647809
N Engl J Med. 2007 Nov 22;357(21):2189-94
pubmed: 18032770
PLoS One. 2014 Jun 17;9(6):e100100
pubmed: 24936656
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
J Card Fail. 2004 Oct;10(5):390-6
pubmed: 15470649
Behav Modif. 2011 Mar;35(2):111-61
pubmed: 21324944
Am J Med. 2000 Jan;108(1):2-8
pubmed: 11059434
J Heart Lung Transplant. 1992 Mar-Apr;11(2 Pt 1):273-9
pubmed: 1576133
Med Care. 2001 Aug;39(8):785-99
pubmed: 11468498
Int J Cardiol. 2016 Oct 15;221:246-50
pubmed: 27404684
Heart Fail Rev. 2017 Nov;22(6):731-741
pubmed: 28733911
J Am Coll Cardiol. 2001 Jul;38(1):199-205
pubmed: 11451275
Prog Cardiovasc Nurs. 2006 Fall;21(4):202-11
pubmed: 17170596
J Gen Intern Med. 2013 Oct;28(10):1268-78
pubmed: 23649787
Congest Heart Fail. 2005 Nov-Dec;11(6):303-10
pubmed: 16330905
Health Technol Assess. 2018 May;22(30):1-220
pubmed: 29856312
J Am Coll Cardiol. 2000 Apr;35(5):1245-55
pubmed: 10758967
J Card Fail. 2007 Dec;13(10):818-24
pubmed: 18068614
Health Qual Life Outcomes. 2013 May 25;11:84
pubmed: 23706131
N Engl J Med. 2017 Oct 5;377(14):1391-1398
pubmed: 28976864
Heart Lung. 2004 Nov-Dec;33(6):354-61
pubmed: 15597288
Stat Med. 2008 Jul 30;27(17):3430-41
pubmed: 18181222
Int J Cardiol. 2013 Aug 20;167(4):1217-25
pubmed: 22507552
Circ Heart Fail. 2013 May;6(3):387-94
pubmed: 23512984
Milbank Q. 1999;77(2):225-56, 174
pubmed: 10392163
J Am Geriatr Soc. 2005 Apr;53(4):695-9
pubmed: 15817019
J Cardiovasc Nurs. 2004 Nov-Dec;19(6 Suppl):S47-56
pubmed: 15529074
Curr Opin Support Palliat Care. 2016 Mar;10(1):24-31
pubmed: 26716392
Trials. 2014 Apr 23;15:139
pubmed: 24755011
J Consult Clin Psychol. 2006 Aug;74(4):658-70
pubmed: 16881773
Patient Educ Couns. 1999 Jun;37(2):113-24
pubmed: 14528539
Cochrane Database Syst Rev. 2005 Jan 25;(1):CD003329
pubmed: 15674906
Stat Med. 2001 Apr 30;20(8):1259-77
pubmed: 11304741
Value Health. 2016 Mar-Apr;19(2):185-91
pubmed: 27021752
JAMA. 2002 Dec 11;288(22):2836-45
pubmed: 12472325
J Am Coll Cardiol. 2011 Jan 25;57(4):418-23
pubmed: 21251581
Am J Psychiatry. 1998 Jan;155(1):4-11
pubmed: 9433332
Biostatistics. 2007 Oct;8(4):708-21
pubmed: 17267392
Int J Geriatr Psychiatry. 2010 Dec;25(12):1209-21
pubmed: 20033905
JAMA. 2009 Nov 18;302(19):2095-103
pubmed: 19918088
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
JAMA. 2007 Jan 24;297(4):367-79
pubmed: 17244833
JACC Heart Fail. 2020 Aug;8(8):681-691
pubmed: 32493638
Lancet. 2016 Aug 27;388(10047):871-80
pubmed: 27461440