Since October 2010 the Catharina-hospital in Eindhoven offers a cardiac rehabilitation program to cardiovascular patients. As an optional section of the program an adjusted training of MBSR is offered, called *stress reduction in cardiovascular…
ID
Source
Brief title
Condition
- Myocardial disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Demographic and clinical characteristics
Age, sex, marital status, level of education and employment will be determined
by questionnaire. Biomedical variables will be obtained form the medical
records, including medications, diagnose and co-morbidity.
Psychological well-being
Psychological well-being will be assessed by using the following five
constructs: symptoms of depression and anxiety, perceived stress, quality of
life and self-worth. Symptoms of depression and anxiety will be assessed using
two self-report questionnaires: the Hospital Anxiety Depression Scales (HADS)
and the Patient Health Questionnaire (PHQ-9). The HADS is a 14-item self-report
screening measure originally developed to evaluate the presence of anxiety and
depressive states in a medical setting20. It consists of two 7-item scales:
anxiety and depression. Evidence for a two-factor solution is found, although
anxiety and depression subscales were strongly correlated. Internal consistency
of the two subscales has been shown to be satisfactory to good (range .71 to
.90) and test-retest stability for anxiety, depression and total scale scores
proved to be very high (.89, .86 and .91 respectively).
The PHQ is a self-report questionnaire used to make criteria-based diagnoses of
depressive and other mental disorders commonly used in primary care21. The
PHQ-9 is the depression module, which inquires all nine DSM-IV criteria on a
4-point scale, ranging from 0 (not at all) to 3 (nearly every day). Major
depression is diagnosed if 5 or more of the 9 depressive symptom criteria have
been present more than half the days in the past 2 weeks, and at least
depressed mood or anhedonia is reported. Next to establishing depressive
disorder diagnoses, the PHQ-9 can also establish grade depressive symptom
severity. Both internal reliability (Cronbach*s α = .89) and test-retest
reliability (.84) have been shown to be excellent. Criterion, construct and
external validity have been shown to be good as well.
Perceived stress will be assessed using the Dutch version of the Perceived
Stress Scale (PSS). This self-report questionnaire consists of 10 items with a
five-point Likert scale ranging from 0 (never) to 4 (very often). It aims to
asses the degree to which situations in one*s life are appraised as stressful
during the past month. The PSS has an internal consistency coefficient of .85,
a test-retest reliability of .85 and is often used in research to determine the
level of perceived stress22.
Quality of life will be measured using the Dutch translation of the Quality of
Life after Myocardial Infarction (QLMI) questionnaire. This self-report
questionnaire is developed on the basis of frequent and important problems
experienced post-MI23. The items are divided in three scales: emotional,
physical and social quality of life. Test-retest reliability is shown to be
high (.75 and .87 for the three domains and total score). Relations between
QLMI and other measures indicates its validity in discriminating between
patients post-MI according to their health-related quality of life, and in
measuring changes in health-related quality of life in time.
Self-esteem will be measured using the Dutch translation of the Rosenberg Self
Esteem Scale (RSES). This is the most widely used instrument for assessing
global self-esteem, defined as a person*s overall evaluation of his or her
worthiness as a human being24. The RSES consists of 10 items and is designed to
represent a continuum of self-worth statements. This questionnaire was
originally designed to asses global trait-like self-esteem and represents a
one-dimensional scale. Research has indicated high internal consistency
(Cronbach*s α = .86), high construct validity with extraversion and
conscientiousness (.32 and .35 respectively) as well as high congruent
validity.
Psychological Mindedness
The degree of PM will be determined by use of the Balanced Index of
Psychological Mindedness (BIPM). This questionnaire consists of two scales
representing the two theoretical core dimensions of PM: a) interest in
attending to one*s psychological phenomena and b) ability for insight into
these phenomena25. These 7-item subscales called Interest and Insight have
shown good internal consistency (Cronbach*s α =.85 and.76 respectively),
test-retest reliability (.63 and .71 respectively) and construct validity with
related constructs (>.40).
Attention problems and hyperactivity
To measure attention problems and hyperactivity a Dutch translation of the ADHD
DSM-IV rating scale, called *Zelf-rapportage vragenlijst voor
aandachtsproblemen en hyperactiviteit in de volwassenheid* is used. This is a
23-item self report questionnaire, with each item to be rated on a four-point
scale. The items are spread over two separate dimensions: inattention (IA) and
hyperactivity-impulsivity (HI)26. These scales had a Cronbach*s alpha of .83,
.75 and.72 respectively. Research supports the external validity of this
questionnaire as well.
Negative affectivity.
Negative affectivity will be measured by the Type D Scale-14 (DS14). The DS14
is developed to assess Negative affectivity (NA), Social Inhibition (SI) and
Type D personality. The questionnaire exists of 14 questions of which seven
questions to assess NA and seven questions to assess SI. Participants answer
the questions on a five-point Likert scale, ranging from 0 (false) to 4 (true).
Both scales can be scored as continuous variables. The seven questions to
assess NA will be used in this research. All of the seven NA items had an
loading ranging between 0.62 and 0.82 on their trait factor. Test-retest
correlation with an interval of three months for the NA scale is .72 .
Heart-focused Anxiety
HFA can be measured with the Cardiac Anxiety Questionnaire. The questionnaire
exists of 18 questions that can be answered on a five-point Likert scale as to
how frequently the behavior typically occurs with response anchors from 0
(never) to 4 (always). The total score can be obtained by adding up all
responses to the items and dividing the sum total by 18, i.e. the mean. The
questionnaire exits of three subscales: fear, avoidance and heart-focused
attention. Higher scores indicate greater HFA. Internal consistency is high for
the CAQ with Cronbach*s alpha=0.83.
Secondary outcome
Not applicable
Background summary
Introduction
Cardiovascular diseases caused by atherosclerosis are one of the two most
important causes of morbidity and mortality in the Netherlands. Research has
revealed that cardiovascular diseases often lead to psychological complaints,
like feelings of anxiety or depression. These negative emotions themselves have
been related to an increased morbidity and worse prognosis of cardiovascular
diseases. Therefore it is necessary to study interventions that might reduce
these feelings of anxiety, stress or depression in this patient group.
Heart-focused anxiety (HFA) is defined in Hoyer et al. (2008)
as: *a specific fear of cardiac-related stimuli and sensations because of their
expected negative consequences.* Earlier research suggests that HFA is
significantly correlated with increased symptoms of general anxiety, depression
and lower health-related quality of life among patients who have to undergo a
cardiac surgery (Ong, Nolan, Ivine & Kovacs, 2011). Patients dealing with HFA
are consulting their physicians more often and require more physical
examinations to get reassurance that everything is all right (6). In addition
to a relieve of the anxiety of the patient, treatment of HFA may help reduce
excessive use of care and health care costs (Fischer et al., 2012)
A relatively new kind of psychological intervention, aimed at reduction
of psychological symptoms of distress and enhancement of quality of life, is
based on Mindfulness. Mindfulness focuses on cultivating awareness of whatever
happens at each successive moment of perception and to do so in an open-minded
and non-judgmental way. Objects of perception range from internal psychological
states and processes, proprioceptive information from the body to external
stimuli. By practicing meditation people learn to recognize thoughts and
feelings as only mental events instead of part of the self or the right
reflection of the truth. The mindfulness stress reduction (MBSR) intervention
is a mindfulness based therapy. It is provided in eight to ten group meetings.
Psycho-education is used as well as practicing mindfulness skills and homework
assignments. Several studies have found that MBSR can reduce perceived feelings
of stress and negative affect and can increase positive affect and quality of
life. A recent meta-analysis revealed a medium to large effect size on anxiety
and depression depending on the patient group studied. The usefulness of this
intervention has also been revealed for a broad range of chronic disorders and
problems. However, relatively few researchers have examined the effectiveness
of MBSR in cardiovascular patients. Only one pilot study revealed significant
reductions in scores of anxiety and emotional control in women diagnosed with
heart disease.
Psychological Mindedness (PM) is the awareness and understanding of
psychological processes, like thoughts, feelings and behaviour. The aim of MBSR
is to increase awareness of these psychological states and processes. Therefore
a high degree of PM may facilitate this awareness and the degree of PM is
expected to influence the effectiveness of MBSR. Brown and Ryan have found that
PM and mindfulness correlate. Other research has found evidence for a possible
moderating role of PM on the effectiveness of MBSR in a healthy population: the
effectiveness of MBSR is larger for people who score high on PM compared to
people who score low on PM.
Beside PM the effectivity of MBSR might be influenced by any problems
of inattention or hyperactivity while it is important to be able to focus
attention on anything you want to observe. Research has found that mindfulness
is negatively associated with ADHD. Problems of inattention or hyperactivity
might impede focussing attention on these stimuli and thereby might reduce
awareness and acceptation. No empirical research has been carried out to
examine this possible moderating role of attention problems or hyperactivity on
the effectiveness of MBSR. A study towards the effect of a personalized health
plan with cardiac patients showed that patients in the active treatment group
had higher cardiac risk reduction compared with the usual care group. To
accomplish better results and to identify the best treatment for each
individual it would be interesting to do some more research to patients
characteristics. In a sample of patients with diabetes, negative affectivity
was found to significantly moderate the effect of mindfulness based cognitive
therapy on levels of anxiety. MBCT appeared to be more effective in reducing
symptoms in individuals with a high level of negative affectivity when compared
with individuals with lower levels of negative affectivity
Study objective
Since October 2010 the Catharina-hospital in Eindhoven offers a cardiac
rehabilitation program to cardiovascular patients. As an optional section of
the program an adjusted training of MBSR is offered, called *stress reduction
in cardiovascular diseases*. It is needed to investigate the effects of this
mindfulness intervention on psychological well-being of this specific patient
group either to make sure the best care is provided and to improve the care if
necessary. As mentioned earlier patients with cardiovascular diseases concern a
group that often show psychological complaints, like feeling of anxiety or
depression which makes it even more important to examine their psychological
care. That is why the main aim of the study is to examine the effectiveness of
this mindfulness based stress reduction intervention on the psychological well
being of heart revalidation patients and to examine whether these effects last
in the long term. Based on previous research medium to large effect sizes are
expected for the effects of the mindfulness based stress reduction intervention
on psychological well-being and these effects are hypothesised to last in the
long term.
Because the effectiveness might depend on the degree of PM, problems of
attention and hyperactivity and negative affectivity, it is needed to examine
the possible moderating role of these variables. If one of these turns out to
be a moderator, the care for this patient group may become more patient
centered in the future. Therefore the second aim of the study is to examine the
possible moderating role of these psychological variables on the effectiveness
of the mindfulness intervention. It is hypothesised that the degree of PM,
attention problems, hyperactivity and negative affectivity all four will
moderate the effectiveness of the intervention on psychological well-being.
Study design
The study is a controlled trial and a quasi-experimental research with two
groups. The study is prospective in nature and will have repeated measures.
At the end of the information module about the psychological load of having a
cardiovascular disease patients get informed about the training *stress
reduction in cardiovascular diseases* and the corresponding study. All patients
that attend the information module receive an information letter. This letter
contains a coupon where people can indicate whether they are interested in
participating the training and/or the study. Together with the letter people
receive a postage-payed envelope by which the coupon can be returned. For
patients who return their coupon, inclusion and exclusion criteria are checked.
Participants have to fill in a couple of questionnaires on three moments before
the course starts, at the end of the course and a year after. The
questionnaires contain questions about anxiety, depression, quality of life and
other psychological variables. The questionnaires can be returned in a
postage-payed envelope. A written informed consent is also attached to these
questionnaires.
Intervention
The applied intervention is a mindfulness training based on MBSR, developed by
dr. J. Kabatt-Zinn at the University of Massachusetts19,8. The adjusted program
offered in this study is less intensive.
The intervention consists of four weekly meetings of 1,5 to 2 hours with an
evaluation meeting as final meeting. The first meeting will be focusing on the
body and bodily sensations. Aim is to enhance the awareness of the body and
posture. Meditation exercises will be done and there is an opportunity to share
experiences. In the second meeting the emphasis is on feelings. Aim is to
observe feelings and to accept them. It is taught that emotions are only a
reaction on a stimulus. Thoughts are the topic of the third meeting. Exercises
will be done to learn how to think *neutral* and without judging. The fourth
and last meeting is about evaluating the course and the experiences in real
life. It is a group intervention with four to six participants per group. The
meetings will be supervised by a clinical psychologist - psychotherapist, who
is experienced in leading attention- and meditation trainings. Participants
receive an information booklet with exercises defined.
Study burden and risks
The intervention is a simplified training based on MBSR. MBSR is a mindfulness
based stress reduction program. There are no riscs attached to participation in
the training. Participants have to fill in questionnaires at three moments.
Michelangelolaan 2
Eindhoven 5602 ZA
NL
Michelangelolaan 2
Eindhoven 5602 ZA
NL
Listed location countries
Age
Inclusion criteria
Documented cardiovascular disease
Age: 18-85 years
Participation in the cardiac rehabilitation program
Exclusion criteria
Severe somatic co-morbidity
Psychiatric co-morbidity
insufficient command of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL34522.060.11 |