Abstract
Introduction: Female patients are at elevated risk for adverse mental health outcomes following hospital admission for ischemic heart disease. These psychosocial characteristics are correlated with unacceptably higher rates of cardiovascular (CV) morbidity and mortality. Guidelines to address mental health following acute coronary syndrome (ACS) can only be developed with the aid of studies elucidating which subgroups of female patients are at the highest risk. Methods/Design: The Female Risk factors for post-Infarction Depression and Anxiety (FRIDA) Study is a prospective multicenter questionnaire-based study of female participants admitted to hospital with ACS. Data are collected within 72 h of admission as well as at 3 and 6 months. At baseline, participants complete a sociodemographic questionnaire, social support survey, and Hospital Depression and Anxiety Scale (HADS). Follow-up will consist of a demographic questionnaire, HADS, changes to health status, and quality of life indicators. Statistical analysis will include descriptive and inferential methods to observe baseline distributions and significance between groups. Discussion/Conclusion: Our primary outcome is to determine if specific CV and sociodemographic factors correlate with increased depression and anxiety scores (HADS-D >7; HADS-A >7) at baseline. Our secondary aim is to determine if increased HADS scores at baseline and follow-up correlate with 3 and 6-month health and quality of life outcomes. A total of 2,000 patients will be enrolled across seven study sites. The aim of the FRIDA Study is to understand which groups of female patients have the highest rates of depression and anxiety following ACS to better inform care.
References
1.
Organization WH
. The top 10 causes of death
; 2020
.2.
Ketterer
MW
, Denollet
J
, Chapp
J
, Thayer
B
, Keteyian
S
, Clark
V
, . Men deny and women cry, but who dies? Do the wages of “denial” include early ischemic coronary heart disease
. J Psychosom Res
. 2004
;56
(1
):119
–23
.3.
Bjerkeset
O
, Nordahl
HM
, Mykletun
A
, Holmen
J
, Dahl
AA
. Anxiety and depression following myocardial infarction: gender differences in a 5-year prospective study
. J Psychosom Res
. 2005
;58
(2
):153
–61
.4.
Frasure-Smith
N
, Lesperance
F
, Juneau
M
, Talajic
M
, Bourassa
MG
. Gender, depression, and one-year prognosis after myocardial infarction
. Psychosom Med
. 1999
;61
(1
):26
–37
.5.
Frasure-Smith
N
, Lesperance
F
, Talajic
M
. Depression and 18-month prognosis after myocardial infarction
. Circulation
. 1995
;91
(4
):999
–1005
.6.
Kala
P
, Hudakova
N
, Jurajda
M
, Kasparek
T
, Ustohal
L
, Parenica
J
, . Depression and anxiety after acute myocardial infarction treated by primary PCI
. PLoS One
. 2016
;11
(4
):e0152367
.7.
Parashar
S
, Rumsfeld
JS
, Reid
KJ
, Buchanan
D
, Dawood
N
, Khizer
S
, . Impact of depression on sex differences in outcome after myocardial infarction
. Circ Cardiovasc Qual Outcomes
. 2009
;2
(1
):33
–40
.8.
Smolderen
KG
, Spertus
JA
, Reid
KJ
, Buchanan
DM
, Krumholz
HM
, Denollet
J
, . The association of cognitive and somatic depressive symptoms with depression recognition and outcomes after myocardial infarction
. Circ Cardiovasc Qual Outcomes
. 2009
;2
(4
):328
–37
.9.
Akhtar
MS
, Malik
SB
, Ahmed
MM
. Symptoms of depression and anxiety in post-myocardial infarction patients
. J Coll Physicians Surg Pak
. 2004
;14
(10
):615
–8
.10.
McLean
CP
, Asnaani
A
, Litz
BT
, Hofmann
SG
. Gender differences in anxiety disorders: prevalence, course of illness, comorbidity and burden of illness
. J Psychiatr Res
. 2011
;45
(8
):1027
–35
.11.
Moser
DK
, Riegel
B
, McKinley
S
, Doering
LV
, An
K
, Sheahan
S
. Impact of anxiety and perceived control on in-hospital complications after acute myocardial infarction
. Psychosom Med
. 2007
;69
(1
):10
–6
.12.
Kuhl
EA
, Fauerbach
JA
, Bush
DE
, Ziegelstein
RC
. Relation of anxiety and adherence to risk-reducing recommendations following myocardial infarction
. Am J Cardiol
. 2009
;103
(12
):1629
–34
.13.
Yusuf
S
, Hawken
S
, Ounpuu
S
, Dans
T
, Avezum
A
, Lanas
F
, . Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the interheart study): case-control study
. Lancet
. 2004
;364
(9438
):937
–52
.14.
Zigmond
AS
, Snaith
RP
. The hospital anxiety and depression scale
. Acta Psychiatr Scand
. 1983
;67
(6
):361
–70
.15.
Liblik
K
, Mulvagh
SL
, Hindmarch
CCT
, Alavi
N
, Johri
AM
. Depression and anxiety following acute myocardial infarction in women
. Trends Cardiovasc Med
. 2022
;32
(6
):341
–7
.16.
Held
C
, Liblik
K
, Mulvagh
SL
, Hindmarch
C
, Alavi
N
, Johri
AM
. Editorial commentary: emotional distress in women after acute myocardial infarction: still a long way to walk
. Trends Cardiovasc Med
. 2022
;32
(6
):348
–9
.17.
Liblik
K
, Hu
R
, Gomes
Z
, Foldes-Busque
G
, Mensour
E
, Sedlak
T
, . Female risk factors for post-myocardial infarction depression and anxiety (FRIDA): pilot results
. Gen Hosp Psychiatry
. 2022
;78
:138
–40
.18.
Smolderen
KG
, Buchanan
DM
, Gosch
K
, Whooley
M
, Chan
PS
, Vaccarino
V
, . Depression treatment and 1-year mortality after acute myocardial infarction: insights from the TRIUMPH registry (translational research investigating underlying disparities in acute myocardial infarction patients’ health status)
. Circulation
. 2017
;135
(18
):1681
–9
.19.
Appelman
Y
, van Rijn
BB
, Ten Haaf
ME
, Boersma
E
, Peters
SAE
. Sex differences in cardiovascular risk factors and disease prevention
. Atherosclerosis
. 2015
;241
(1
):211
–8
.20.
Thygesen
K
, Alpert
JS
, Jaffe
AS
, Chaitman
BR
, Bax
JJ
, Morrow
DA
, . Fourth universal definition of myocardial infarction (2018)
. Glob Heart
. 2018
;13
(4
):305
–38
.21.
Moser
DK
, Dracup
K
, McKinley
S
, Yamasaki
K
, Kim
CJ
, Riegel
B
, . An international perspective on gender differences in anxiety early after acute myocardial infarction
. Psychosom Med
. 2003
;65
(4
):511
–6
.22.
AbuRuz
ME
, Masa’Deh
R
. Gender differences in anxiety and complications early after acute myocardial infarction
. J Cardiovasc Nurs
. 2017
;32
(6
):538
–43
.23.
Hoskings
JD
. Enhancing recovery in coronary heart disease patients (ENRICHD): study design and methods
. Am Heart J
. 2000
;139
(1
):1
–9
.24.
Vaglio
J
, Jr., Conard
M
, Poston
WS
, O’Keefe
J
, Haddock
CK
, House
J
, . Testing the performance of the ENRICHD social support instrument in cardiac patients
. Health Qual Life Outcomes
. 2004
;2
:24
.25.
Hicks
KA
, Mahaffey
KW
, Mehran
R
, Nissen
SE
, Wiviott
SD
, Dunn
B
, . 2017 cardiovascular and stroke endpoint definitions for clinical trials
. J Am Coll Cardiol
. 2018
;71
(9
):1021
–34
.26.
Thygesen
K
, Alpert
JS
, Jaffe
AS
, Chaitman
BR
, Bax
JJ
, Morrow
DA
, . Fourth universal definition of myocardial infarction (2018)
. J Am Coll Cardiol
. 2018
;72
(18
):2231
–64
.27.
Braunwald
E
, Antman
EM
, Beasley
JW
, Califf
RM
, Cheitlin
MD
, Hochman
JS
, . ACC/AHA guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--2002: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina)
. Circulation
. 2002
;106
(14
):1893
–900
.28.
Eifert
GH
, Thompson
RN
, Zvolensky
MJ
, Edwards
K
, Frazer
NL
, Haddad
JW
, . The cardiac anxiety questionnaire: development and preliminary validity
. Behav Res Ther
. 2000
;38
(10
):1039
–53
.29.
Sherbourne
CD
, Stewart
AL
. The MOS social support survey
. Soc Sci Med
. 1991
;32
(6
):705
–14
.30.
Muller-Nordhorn
J
, Roll
S
, Willich
SN
. Comparison of the short form (SF)-12 health status instrument with the SF-36 in patients with coronary heart disease
. Heart
. 2004
;90
(5
):523
–7
.31.
Carney
RM
, Freedland
KE
. Are somatic symptoms of depression better predictors of cardiac events than cognitive symptoms in coronary heart disease
. Psychosom Med
. 2012
;74
(1
):33
–8
.32.
Harris
PA
, Taylor
R
, Thielke
R
, Payne
J
, Gonzalez
N
, Conde
JG
. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support
. J Biomed Inform
. 2009
;42
(2
):377
–81
.33.
Cochran
WG
. Sampling techniques
. 3rd ed.New York
: John Wiley & Sons
; 1977
.34.
Peduzzi
P
, Concato
J
, Kemper
E
, Holford
TR
, Feinstein
AR
. A simulation study of the number of events per variable in logistic regression analysis
. J Clin Epidemiol
. 1996
;49
(12
):1373
–9
.35.
Kim
YS
. Comparison of the decision tree, artificial neural network, and linear regression methods based on the number and types of independent variables and sample size
. Expert Syst Appl
. 2008
;34
(2
):1227
–34
.36.
Morgan
J
, Daugherty
R
, Hilchie
A
, Carey
B
. Sample size and modeling accuracy of decision tree based data mining tools
. Acad Inf Manag Sci J
. 2003
;6
(2
):77
–91
.37.
Vollmer
S
, Mateen
BA
, Bohner
G
, Kiraly
FJ
, Ghani
R
, Jonsson
P
, . Machine learning and artificial intelligence research for patient benefit: 20 critical questions on transparency, replicability, ethics, and effectiveness
. BMJ
. 2020
;368
:l6927
.38.
Strik
JJ
, Honig
A
, Lousberg
R
, Denollet
J
. Sensitivity and specificity of observer and self-report questionnaires in major and minor depression following myocardial infarction
. Psychosomatics
. 2001
;42
(5
):423
–8
.39.
Mykletun
A
, Bjerkeset
O
, Overland
S
, Prince
M
, Dewey
M
, Stewart
R
. Levels of anxiety and depression as predictors of mortality: the HUNT study
. Br J Psychiatry
. 2009
;195
(2
):118
–25
.40.
Martin
CR
, Lewin
RJP
, Thompson
DR
. A confirmatory factor analysis of the Hospital Anxiety and Depression Scale in coronary care patients following acute myocardial infarction
. Psychiatry Res
. 2003
;120
(1
):85
–94
.41.
Murphy
B
, Le Grande
M
, Alvarenga
M
, Worcester
M
, Jackson
A
. Anxiety and depression after a cardiac event: prevalence and predictors
. Front Psychol
. 2019
;10
:3010
.42.
Celano
CM
, Millstein
RA
, Bedoya
CA
, Healy
BC
, Roest
AM
, Huffman
JC
. Association between anxiety and mortality in patients with coronary artery disease: a meta-analysis
. Am Heart J
. 2015
;170
(6
):1105
–15
.43.
Meyer
T
, Hussein
S
, Lange
HW
, Herrmann-Lingen
C
. Anxiety is associated with a reduction in both mortality and major adverse cardiovascular events five years after coronary stenting
. Eur J Prev Cardiol
. 2015
;22
(1
):75
–82
.44.
Freedman
SA
, Gluck
N
, Tuval-Mashiach
R
, Brandes
D
, Peri
T
, Shalev
AY
. Gender differences in responses to traumatic events: a prospective study
. J Trauma Stress
. 2002
;15
(5
):407
–13
.45.
Mayou
RA
, Gill
D
, Thompson
DR
, Day
A
, Hicks
N
, Volmink
J
, . Depression and anxiety as predictors of outcome after myocardial infarction
. Psychosom Med
. 2000
;62
(2
):212
–9
.46.
Lane
D
, Carroll
D
, Ring
C
, Beevers
DG
, Lip
GY
. Mortality and quality of life 12 months after myocardial infarction: effects of depression and anxiety
. Psychosom Med
. 2001
;63
(2
):221
–30
.47.
Norlund
F
, Lissaker
C
, Wallert
J
, Held
C
, Olsson
EM
. Factors associated with emotional distress in patients with myocardial infarction: results from the swedeheart registry
. Eur J Prev Cardiol
. 2018
;25
(9
):910
–20
.48.
Clarke
SP
, Frasure-Smith
N
, Lesperance
F
, Bourassa
MG
. Psychosocial factors as predictors of functional status at 1 year in patients with left ventricular dysfunction
. Res Nurs Health
. 2000
;23
(4
):290
–300
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