Introduction: Randomized controlled trials (RCT) of psychotherapeutic interventions have addressed depression and demoralization associated with acute coronary syndromes (ACS). The present trial introduces psychological well-being, an increasingly recognized factor in cardiovascular health, as a therapeutic target. Objective: This study was designed to determine whether the sequential combination of cognitive-behavioral therapy (CBT) and well-being therapy (WBT) may yield more favorable outcomes than an active control group (clinical management; CM) and to identify subgroups of patients at greater risk for cardiac negative outcomes. Methods: This multicenter RCT comparedCBT/WBT sequential combination versus CM, with up to 30 months of follow-up. One hundred consecutive depressed and/or demoralized patients (out of 740 initially screened by cardiologists after a first episode of ACS) were randomized to CBT/WBT associated with lifestyle suggestions (n = 50) and CM (n = 50). The main outcome measures included: severity of depressive symptoms according to the Clinical Interview for Depression, changes in subclinical psychological distress, well-being, and biomarkers, and medical complications and events. Results: CBT/WBT sequential combination was associated with a significant improvement in depressive symptoms compared to CM. In both groups, the benefits persisted at follow-up, even though the differences faded. Treatment was also related to a significant amelioration of biomarkers (platelet count, HDL, and D-dimer), whereas the 2 groups showed similar frequencies of adverse cardiac events. Conclusions: Addressing psychological well-being in the psychotherapeutic approach to ACS patients with depressive symptoms was found to entail important clinical benefits. It is argued that lifestyle changes geared toward cardiovascular health may be facilitated by a personalized approach that targets well-being.

1.
Carney
RM
,
Freedland
KE
.
Depression and coronary heart disease
.
Nat Rev Cardiol
.
2017
Mar
;
14
(
3
):
145
55
.
[PubMed]
1759-5002
2.
Rafanelli
C
,
Roncuzzi
R
,
Milaneschi
Y
,
Tomba
E
,
Colistro
MC
,
Pancaldi
LG
, et al.
.
Stressful life events, depression and demoralization as risk factors for acute coronary heart disease
.
Psychother Psychosom
.
2005
;
74
(
3
):
179
84
.
[PubMed]
0033-3190
3.
Kuhlmann
SL
,
Arolt
V
,
Haverkamp
W
,
Martus
P
,
Ströhle
A
,
Waltenberger
J
, et al.
.
Prevalence, 12-month prognosis, and clinical management need of depression in coronary heart disease patients
.
Psychother Psychosom
.
2019
;
88
(
5
):
300
11
.
[PubMed]
0033-3190
4.
de Figueiredo
JM
,
Frank
JD
.
Subjective incompetence, the clinical hallmark of demoralization
.
Compr Psychiatry
.
1982
Jul-Aug
;
23
(
4
):
353
63
.
[PubMed]
0010-440X
5.
Kim
JM
,
Stewart
R
,
Lee
YS
,
Lee
HJ
,
Kim
MC
,
Kim
JW
, et al.
.
Effect of escitalopram vs placebo treatment for depression on long-term cardiac outcomes in patients with acute coronary syndrome: a randomized clinical trial
.
JAMA
.
2018
Jul
;
320
(
4
):
350
8
.
[PubMed]
0098-7484
6.
Reavell
J
,
Hopkinson
M
,
Clarkesmith
D
,
Lane
DA
.
Effectiveness of cognitive behavioral therapy for depression and anxiety in patients with cardiovascular disease: A systematic review and meta-analysis
.
Psychosom Med
.
2018
Oct
;
80
(
8
):
742
53
.
[PubMed]
0033-3174
7.
Berkman
LF
,
Blumenthal
J
,
Burg
M
,
Carney
RM
,
Catellier
D
,
Cowan
MJ
, et al.;
Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD)
.
Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial
.
JAMA
.
2003
Jun
;
289
(
23
):
3106
16
.
[PubMed]
0098-7484
8.
Kubzansky
LD
,
Huffman
JC
,
Boehm
JK
,
Hernandez
R
,
Kim
ES
,
Koga
HK
, et al.
.
Positive psychological well-being and cardiovascular disease: JACC health promotion series
.
J Am Coll Cardiol
.
2018
Sep
;
72
(
12
):
1382
96
.
[PubMed]
0735-1097
9.
Fava
GA
.
Well-being therapy: Treatment manual and clinical applications
.
Basel, Switzerland
:
Karger Medical & Scientific Publishers
;
2016
.
10.
Guidi
J
,
Rafanelli
C
,
Fava
GA
.
The clinical role of well-being therapy
.
Nord J Psychiatry
.
2018
Aug
;
72
(
6
):
447
53
.
[PubMed]
0803-9488
11.
Fava
GA
,
Rafanelli
C
,
Grandi
S
,
Conti
S
,
Belluardo
P
.
Prevention of recurrent depression with cognitive behavioral therapy: preliminary findings
.
Arch Gen Psychiatry
.
1998
Sep
;
55
(
9
):
816
20
.
[PubMed]
0003-990X
12.
American Psychiatric Association
.
Diagnostic and Statistical Manual of Mental Disorders
. 4th ed., revised.
Washington (DC)
:
American Psychiatric Association
;
2000
.
13.
Fava
GA
,
Freyberger
HJ
,
Bech
P
,
Christodoulou
G
,
Sensky
T
,
Theorell
T
, et al.
.
Diagnostic criteria for use in psychosomatic research
.
Psychother Psychosom
.
1995
;
63
(
1
):
1
8
.
[PubMed]
0033-3190
14.
Tang
EW
,
Wong
CK
,
Herbison
P
.
Global Registry of Acute Coronary Events (GRACE) hospital discharge risk score accurately predicts long-term mortality post acute coronary syndrome
.
Am Heart J
.
2007
Jan
;
153
(
1
):
29
35
.
[PubMed]
0002-8703
15.
First
MB
,
Spitzer
RL
,
Gibbon
M
,
Williams
J
.
Structured Clinical Interview for DSM-IV-TR Axis I Disorders, research version
.
New York (NY)
:
Biometrics Research, New York State Psychiatric Institute
;
2002
.
16.
Porcelli
P
,
Sonino
N
.
Psychological Factors Affecting Medical Conditions. A New Classification for DSM-V. Advances in Psychosomatic Medicine
.
Basel, Switzerland
:
Karger
;
2007
.
17.
Tecuta
L
,
Tomba
E
,
Grandi
S
,
Fava
GA
.
Demoralization: a systematic review on its clinical characterization
.
Psychol Med
.
2015
Mar
;
45
(
4
):
673
91
.
[PubMed]
0033-2917
18.
Galeazzi
GM
,
Ferrari
S
,
Mackinnon
A
,
Rigatelli
M
.
Interrater reliability, prevalence, and relation to ICD-10 diagnoses of the Diagnostic Criteria for Psychosomatic Research in consultation-liaison psychiatry patients
.
Psychosomatics
.
2004
Sep-Oct
;
45
(
5
):
386
93
.
[PubMed]
0033-3182
19.
Paykel
ES
.
The clinical interview for depression. Development, reliability and validity
.
J Affect Disord
.
1985
Jul
;
9
(
1
):
85
96
.
[PubMed]
0165-0327
20.
Guidi
J
,
Fava
GA
,
Bech
P
,
Paykel
E
.
The Clinical Interview for Depression: a comprehensive review of studies and clinimetric properties
.
Psychother Psychosom
.
2011
;
80
(
1
):
10
27
.
[PubMed]
0033-3190
21.
Hamilton
M
.
Development of a rating scale for primary depressive illness
.
Br J Soc Clin Psychol
.
1967
Dec
;
6
(
4
):
278
96
.
[PubMed]
0007-1293
22.
Carrozzino
D
,
Patierno
C
,
Fava
GA
,
Guidi
J
.
The Hamilton Rating Scales for Depression: a critical review of clinimetric properties of different versions
.
Psychother Psychosom
.
2020
;
89
(
3
):
133
50
.
[PubMed]
0033-3190
23.
Kellner
R
.
A symptom questionnaire
.
J Clin Psychiatry
.
1987
Jul
;
48
(
7
):
268
74
.
[PubMed]
0160-6689
24.
Benasi
G
,
Fava
GA
,
Rafanelli
C
.
Kellner’s Symptom Questionnaire, a highly sensitive patient-reported outcome measure: systematic review of clinimetric properties
.
Psychother Psychosom
.
2020
;
89
(
2
):
74
89
.
[PubMed]
0033-3190
25.
Ryff
CD
.
Happiness is everything, or is it? Explorations on the meaning of psychological well-being
.
J Pers Soc Psychol
.
1989
;
57
(
6
):
1069
81
. 0022-3514
26.
Ryff
CD
.
Psychological well-being revisited: advances in the science and practice of eudaimonia
.
Psychother Psychosom
.
2014
;
83
(
1
):
10
28
.
[PubMed]
0033-3190
27.
Guidi
J
,
Brakemeier
EL
,
Bockting
CL
,
Cosci
F
,
Cuijpers
P
,
Jarrett
RB
, et al.
.
Methodological recommendations for trials of psychological interventions
.
Psychother Psychosom
.
2018
;
87
(
5
):
276
84
.
[PubMed]
0033-3190
28.
Cohen
J
.
Statistical power analysis for the behavioral sciences
.
New York (NY)
:
Routledge Academic
;
1988
.
29.
Brummett
BH
,
Babyak
MA
,
Barefoot
JC
,
Bosworth
HB
,
Clapp-Channing
NE
,
Siegler
IC
, et al.
.
Social support and hostility as predictors of depressive symptoms in cardiac patients one month after hospitalization: a prospective study
.
Psychosom Med
.
1998
Nov-Dec
;
60
(
6
):
707
13
.
[PubMed]
0033-3174
30.
Rafanelli
C
,
Gostoli
S
,
Tully
PJ
,
Roncuzzi
R
.
Hostility and the clinical course of outpatients with congestive heart failure
.
Psychol Health
.
2016
;
31
(
2
):
228
38
.
[PubMed]
0887-0446
31.
von Känel
R
.
Acute mental stress and hemostasis: when physiology becomes vascular harm
.
Thromb Res
.
2015
Feb
;
135
(
1
):
S52
5
. 0049-3848
32.
Vinholt
PJ
,
Hvas
AM
,
Frederiksen
H
,
Bathum
L
,
Jørgensen
MK
,
Nybo
M
.
Platelet count is associated with cardiovascular disease, cancer and mortality: A population-based cohort study
.
Thromb Res
.
2016
Dec
;
148
:
136
42
.
[PubMed]
0049-3848
33.
Ishida
M
,
Itoh
T
,
Nakajima
S
,
Ishikawa
Y
,
Shimoda
Y
,
Kimura
T
, et al.
.
A low early high-density lipoprotein cholesterol level is an independent predictor of in-hospital death in patients with acute coronary syndrome
.
Intern Med
.
2019
Feb
;
58
(
3
):
337
43
.
[PubMed]
0918-2918
34.
Fava
GA
,
Sonino
N
.
Depression associated with medical illness
.
CNS Drugs
.
1996
Oct
;
5
(
3
):
175
89
. 1172-7047
35.
Fava
GA
,
Guidi
J
,
Rafanelli
C
,
Rickels
K
.
The clinical inadequacy of the placebo model and the development of an alternative conceptual framework
.
Psychother Psychosom
.
2017
;
86
(
6
):
332
40
.
[PubMed]
0033-3190
36.
Carvalho
AF
,
Sharma
MS
,
Brunoni
AR
,
Vieta
E
,
Fava
GA
.
The safety, tolerability and risks associated with the use of newer generation antidepressant drugs: a critical review of the literature
.
Psychother Psychosom
.
2016
;
85
(
5
):
270
88
.
[PubMed]
0033-3190
37.
Fava
GA
,
Rafanelli
C
.
Iatrogenic factors in psychopathology
.
Psychother Psychosom
.
2019
;
88
(
3
):
129
40
.
[PubMed]
0033-3190
38.
Grace
SL
,
Medina-Inojosa
JR
,
Thomas
RJ
,
Krause
H
,
Vickers-Douglas
KS
,
Palmer
BA
, et al.
.
Antidepressant use by class: association with major adverse cardiac events in patients with coronary artery disease
.
Psychother Psychosom
.
2018
;
87
(
2
):
85
94
.
[PubMed]
0033-3190
39.
Guidi
J
,
Tomba
E
,
Fava
GA
.
The sequential integration of pharmacotherapy and psychotherapy in the treatment of major depressive disorder: a meta-analysis of the sequential model and a critical review of the literature
.
Am J Psychiatry
.
2016
Feb
;
173
(
2
):
128
37
.
[PubMed]
0002-953X
40.
Nierenberg
B
,
Mayersohn
G
,
Serpa
S
,
Holovatyk
A
,
Smith
E
,
Cooper
S
.
Application of well-being therapy to people with disability and chronic illness
.
Rehabil Psychol
.
2016
Feb
;
61
(
1
):
32
43
.
[PubMed]
0090-5550
41.
Rafanelli
C
,
Roncuzzi
R
,
Finos
L
,
Tossani
E
,
Tomba
E
,
Mangelli
L
, et al.
.
Psychological assessment in cardiac rehabilitation
.
Psychother Psychosom
.
2003
Nov-Dec
;
72
(
6
):
343
9
.
[PubMed]
0033-3190
42.
Gostoli
S
,
Roncuzzi
R
,
Urbinati
S
,
Morisky
DE
,
Rafanelli
C
.
Unhealthy behaviour modification, psychological distress, and 1-year survival in cardiac rehabilitation
.
Br J Health Psychol
.
2016
Nov
;
21
(
4
):
894
916
.
[PubMed]
1359-107X
43.
Gostoli
S
,
Roncuzzi
R
,
Urbinati
S
,
Rafanelli
C
.
Clinical and subclinical distress, quality of life and psychological well-being after cardiac rehabilitation
.
Appl Psychol Health Well-Being
.
2017
Nov
;
9
(
3
):
349
69
.
[PubMed]
1758-0846
44.
Turk-Adawi
KI
,
Oldridge
NB
,
Tarima
SS
,
Stason
WB
,
Shepard
DS
.
Cardiac rehabilitation enrollment among referred patients: patient and organizational factors
.
J Cardiopulm Rehabil Prev
.
2014
Mar-Apr
;
34
(
2
):
114
22
.
[PubMed]
1932-7501
45.
Zullo
MD
,
Gathright
EC
,
Dolansky
MA
,
Josephson
RA
,
Cheruvu
VK
,
Hughes
JW
.
The influence of depression on utilization of cardiac rehabilitation post-myocardial infarction: A study of 158,991 Medicare Beneficiaries
.
J Cardiopulm Rehabil Prev
.
2017
Jan
;
37
(
1
):
22
9
.
[PubMed]
1932-7501
46.
Rippe
JM
.
Are we ready to practice lifestyle medicine
.
Am J Med
.
2019
Jan
;
132
(
1
):
6
8
.
[PubMed]
0002-9343
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