Download Chronic anxiety in ICD patients: A multi

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WEB-based distress management program for implantable
CARdioverter dEfibrillator patients (WEBCARE)
Susanne S. Pedersen, Professor of Cardiac Psychology
Center of Research
on Psychology
in Somatic diseases
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Project participants
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• Susanne S. Pedersen (PI; PhD)
• Viola Spek (Project leader; PhD)
• Krista van den Broek (PhD)
• Johan Denollet (PhD)
• Mirela Habibovic (MSc)
Erasmus Medical Center, Rotterdam
• Luc Jordaens (MD, PhD)
• Dominic Theuns (PhD)
• Agnes Muskens-Heemskerk
Amphia Hospital, Breda
• Marco Alings (MD, PhD)
Catharina Hospital, Eindhoven
• Pepijn van der Voort (MD)
Free University, Amsterdam
• Pim Cuijpers (PhD)
STIN (Stichting ICD dragers Nederland)
• Peter Zaadstra (Projectadvisor)
Funding agency
• The Netherlands Organisation for Health
Research and Development, the Hague ZonMw (grant no. 300020002)
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Overview
• Background
• Objectives of WEBCARE
• WEBCARE
– Patient population
– Design
– Measures
– Intervention
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Overview
• Background
• Objectives of WEBCARE
• WEBCARE
– Patient population
– Design
– Measures
– Intervention
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Rise in ICD implantations
2002
MADIT-II
2000
CRT-D
2004
SCD-HeFT
1997/8
Number of Worldwide ICD Implants Per Year
DC-ICD
COMPANION
90.000
1980
1989
800,000 heart patients
First Human
in
Europe and 1 mill in
Implant
1985
North America
have a
cardiovascular implantable
FDA
Approval of
electronic device
80.000
70.000
60.000
•Transvenous Leads
•Biphasic Waveform
ICDs
50.000
40.000
AVID
CASH
CIDS
1993
Smaller
Devices
1999
 MUSTT
1988
30.000
Tiered
Therapy
20.000
1996
 MADIT
10.000
0
1980
1985
1990
Crespo et al. Am J Med Sci 2005;329:238-46
1995
2000
2005
What
is
an
implantable
cardioverter
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defibrillator (ICD)?
• The ICD can shock with up to 700800 volts
• “It’s like getting kicked in the chest
by a big horse!”
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ICD therapy: Benefits and side effects
Epstein, J Am Coll Cardiol 2008
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ICD therapy: Benefits and side effects
• Complications (lead fractures, dislodgement, and infection)
• Shocks that are inappropriate  mortality risk ?
• Potential malfunctioning, as notified with a device recall
• Significant anxiety and depression in 20-30% of patients
• Patient´s psychological reaction to the device may increase
the risk of arrhythmias
Risk that patients will refuse this potentially
life-saving treatment
Tung et al. JACC 2008; Pedersen et al. PACE 2009;32:1006-11
Versteeg.... & Pedersen. PACE, 2009 Aug 21. [Epub ahead of print]
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Continuum of shock response
Shock continuum
No shocks
Cumulative shocks
ICD storms
Anxiety spectrum
Normalised
fear
Shock phobias
(e.g. exertion)
Generalised
anxiety
PTSD
Thoughts and behaviors
“The ICD keeps
me safe
during exertion”
“The ICD is
my reason
for not exerting”
Sears et al. Heart 2002
“There is very
little that I am
safe to do
with my ICD”
“The ICD does
not keep me
safe”
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Distress and arrhythmias
Mood states also predict arrhythmic events:
–
Mood disturbance (OR: 1.14-1.16) 3 mths and 6
mths arrhythmia
–
15 min prior to shocks, independent effects of
anger, (OR: 1.83), and mild-to-moderate
physical activity (OR: 1.46); no effect for anxiety,
worry, sadness, happiness, challenge, interest,
and in control
Dunbar et al. Depress Anxiety 1999; Lampert et al. Circulation 2002
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Distress and arrhythmias
–
Depression: HR: 3.2 - time to first shock for VT/VF;
HR: 3.2 – all shocks for VT/VF including recurrent
episodes (adjusted analysis)
–
Anxious Type D’s: HR: 1.72 (95% CI: 1.03 to 2.89) 1
year ventricular arrhythmias, independent of sex,
age, ischemic etiology, left ventricular dysfunction,
prolonged QRS duration, and medication); no effect
for anxiety and depressive symptoms
Whang et al. JACC 2005; van den Broek et al. JACC 2009
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ICD shocks - the paradox
Structural heart disease
Electrical instability
Autonomic imbalance
HR  HRV
Inflammation 
Distress
(Anxiety /
Depression)
Danger? Safety?
Tachyarrhythmia /
shock
Increased perception,
dysfunctional appraisal,
maladaptive coping
Personality
Pre-existing distress
Social support
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Intervention in ICD patients
Pedersen, van den Broek, & Sears. PACE 2007
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Four new studies added...
Authors
N (design) FU-period
Outcome
Dunbar
246 (RCT)
12 mths
 anxiety;  depression;  health care
consumption and disability days
Kuhl
30 (RCT)
1 mth
no change in knowledge perception
Lewin
192 (RCT)
6 mths
 anxiety;  depression;  admissions;
 QoL
Sears
30 (RCT)
4 mths
 anxiety;  cortisol
depression in 1-day workshop group
Dunbar et al. PACE 2009; Kuhl et al. J Cardiovasc Nursing 2009;
Lewin et al. Heart 2009; Sears et al. PACE 2007
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Overview
• Background
• Objectives of WEBCARE
• WEBCARE
– Patient population
– Design
– Measures
– Intervention
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OBJECTIVES
Primary:
• To investigate whether the web-based intervention is
superior to usual care in terms of reducing anxiety,
depression, and ICD concerns as well as improving ICD
acceptance and QoL
• To investigate the cost-effectiveness of the web-based
intervention and whether the web-based intervention is
associated with reduced health-care utilization
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Secondary:
• To examine whether psychological (i.e., Type D personality
and positive affect) and clinical factors (i.e., cardiac
resynchronization therapy (CRT)) moderate the effect of
the intervention, with a view to developing risk profiles of
patients who are less likely to benefit from the intervention
Explorative:
• To explore whether the web-based intervention influences
physiological parameters (i.e., ventricular arrhythmias and
the cortisol awakening response (CAR))
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Overview
• Background
• Objectives of WEBCARE
• WEBCARE
– Patient population
– Design
– Measures
– Intervention
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Patient population
Consecutive ICD patients recruited from 3 centers:
₋ Amphia Hospital, Breda
₋ Catharina Hospital, Eindhoven
₋ Erasmus Medical Center, Rotterdam
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Power analysis based on the assumptions :
– expected between group effect size of .30
– alpha = 0.05
– power = 0.80 (two-sided test)
– 350 patients are needed (i.e., 175 in each
condition). Given an expected response rate of
50% (earlier study = 82%) 700 patients need to
be approached
Pedersen et al. Psychosom Med 2004
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Inclusion criteria
•
•
•
•
•
Patients implanted with an ICD
18-75 years of age
Speaking and understanding Dutch
With access to and ability to use the internet
Providing written informed consent
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Exclusion criteria
• A life expectancy less than 1 year
• A history of psychiatric illness other than
affective/anxiety disorders
• On the waiting list for heart transplantation
• With insufficient knowledge of the Dutch
language
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Study design
5-10 days post implantation:
completion of baseline
questionnaire
-T1
T0
Follow-up
Intervention
T1
T2
T3
14
26
52
Usual care
Weeks
0
Hospitalisation
for ICD
implantation
2
Randomisation
to intervention
or usual care
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Self-report measures
Construct
Anxiety
Questionnaire
T0
T1
T2
T3
STAI-S
State Trait Anxiety Inventory (state only)
x
x
x
x
FSAS
Florida Shock Anxiety Scale
x
x
x
x
PDS
Posttraumatic Stress Disorder Scale
x
x
x
DAI-5
Denollet Anxiety Inventory
x
x
x
x
HADS
Hospital Anxiety and Depression Scale
x
x
x
x
PHQ-9
Patient Health Questionnaire
x
x
x
x
SF-12
Short Form Health Survey 12
x
x
x
x
MLWHFQ
Minnesota Living With Heart Failure
Questionnaire
x
x
x
x
ICD concerns
ICDC
ICD Patient Concerns Questionnaire
x
x
x
x
ICD acceptance
FPAS
Florida Patient Acceptance Survey
x
x
x
x
Health care utilization
and cost-effectiveness
TiC-P
Trimbos/iMTA questionnaire for Costs
associated with Psychiatric Illness
x
Type D personality
DS14
Type D Scale
x
Depressive symptoms
Quality of life
T0 = Baseline; T1 = 14 weeks; T2 = 26 weeks; T3 =52 weeks
x
x
x
x
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Physiological measures
• Salivary cortisol, using the Salivette, assessed at 3
out of the 4 time points (i.e., T0 = 5 to 10 days after
ICD implantation; T1 = 14 weeks post-implantation;
T3 = 52 weeks post-implantation)
• Four samples will be taken at each time point and
on the consecutive day, that is (a) when waking up,
(b) ½ hour later, (c) 11.00 a.m., and (d) 3.00 p.m.
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Other measures
• Clinical: ICD indication, etiology, LVEF, CRT, comorbidity, type of ICD therapy (ATP vs. shock;
appropriate vs. inappropriate), QRS-complex,
cardiac medication, etc.
• Demographic: Sex, age, marital status, education,
working status
• Other: Smoking status, participation in cardiac
rehabilitation since ICD implantation, the use of
psychotropic medication, help-seeking from a
psychologist/psychiatrist
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Study endpoints
Primary:
• Anxiety; depression; ICD concerns; ICD acceptance;
quality of life; health care utilization; costeffectiveness of the intervention
Secondary:
• Ventricular arrhythmias; cortisol awakening respons
Long-term:
• Mortality
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Intervention – web application
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Intervention (fixed, 3-month duration)
COMPONENTS
TOPICS DEALT WITH
 Psycho-education about the ICD
 Emotional reactions to ICD
therapy
 Problem-solving skills
 Which aspects of ICD therapy
may lead to distress
 Cognitive restructuring
 Relaxation training
 How to deal with shocks
 Disease-specific issues and fears
 How to prevent the avoidance of
 Personalized feedback by a therapist
activities
via the computer
 Interpretation of bodily
symptoms
 How to cope with uncertainty
 Help-seeking behavior
 How to cope with stress
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Advantages of web-based approach
• Low-threshold accessibility
• Less stigma – no face-to-face meetings with
therapists
• Obtain treatment at any time and place, work at
own pace and review the material as often as
desired
• No extra hospital visits – being reminded less of
illness as the context of the intervention is
different
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Clinical and societal relevance
• Immediate applicability in health care
• Identification of high-risk patients  screening
• Personalized care  optimization of clinical
management of device patients
• Reduced health-care utilization
• Increased cost-effectiveness
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