To examine whether the Positive Psychology group intervention *Goed leven met een hartaandoening* [Living well with heart disorder] is effective in increasing mental well-being, ability to adapt, positive skills (e.g. savouring, positive re-…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is mental well-being, measured with the psychological
well-being subscale of the Dutch version of the Mental Health Continuum - Short
Form (MHC-SF, Lamers, et al., 2011).
Secondary outcome
The secondary outcome measures will be assessed weekly. In order to prevent
from too much burden associated with repeated measures, a small number of items
for each outcome measure will be used in the weekly measures. But the full
versions of the scales for those outcome measures will be measured at three
time points: at the start (together with demographic questions and questions
concerning the heart disease), after the intervention ends and eight weeks
follow-up.
The ability to adapt will be assessed with two items of the ten-item Generic
Sense of Ability to Adapt Scale (GSAAS; Franken et al., under review). Items
will be scored from *not at all* to absolutely, on a five point scale. The
chosen items were those with the highest factor loading of the study of Franken
et al. (under review).
Distress will be assessed with four items, depression with the two item Patient
Health Questionnaire (PHQ-2) and anxiety with the two item Generalized Anxiety
Disorder (GAD-2). Löwe et al. (2004) assessed the construct validity of the
PHQ-2 in medical outpatients and concluded that it is promising for monitoring
depression outcomes over time. Donkers et al. (2011) evaluate the GAD-2 in a
sample of Dutch adults and concluded that web-based version is a valid and
reliable tool to screen for a GAD in a clinical research setting.
Lastly, the positive skills savoring, gratitude, positive reinterpretation and
self-reassurance will be assessed with two items each. The two items on
gratitude are retrieved form the 16 item Gratitude Resentment and Appreciation
Scale (GRAT-16 or S-GRAT; Thomas and Watkins, 2003). The two savoring items are
retrieved form the savoring past subscale of the Savoring Beliefs Inventory
(SBI; Bryant, 2003). The two items on positive reinterpretation are retrieved
from the positive reinterpretation and growth subscale of the COPE inventory
(COPE-I; Carver, 1989). Lastly, the two items on self-reassurance are retrieved
from the eponymous subscale of the FSCRS (Gilbert et al., 2004). These items
will be scored on a seven point Likert scale from strongly disagree (1) to
strongly agree (7) and formulated so participants answer the items about the
previous week, to meet the aim of weekly measures.
The three times (pre, post and at follow-up) questionnaire exists of
demographic questions (e.g. age, gender), the MHC-SF, the full scale of the
GSAAS for ability to adapt, the longer version of the PHQ, namely the nine item
Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999) for depression, the
longer version of the GAD, namely the seven item Generalized Anxiety Disorder
(GAD-7; Kroenke et al., 2001) for anxiety and the full versions of the GRAT for
gratitude, SBI savoring past subscale for savoring, the positive
reinterpretation and growth subscale of the COPE-I for positive
reinterpretation, and the self-reassurance subscale of the FSCRS for
self-reassurance.
In addition to these mental well-being related questionnaires will health
related behavior (i.e. adherence to medication, diet and physical activity) be
measured. Adherence to medication will be measured with a Self-Report
Medication Adherence scale, that was previously used for the pilot study of
this intervention (Tönis et al., 2022) and based upon Lu et al (2008).
Participants will fill in (on a 10% scale) what percentage of time they took
the medication they were prescribed to use over the past two weeks. Adherence
to diet and physical activity will be measured with (relevant) questions of the
Medical Outcomes Study Specific Adherence Scale (MOS-SAS, DiMatteo et
al.,1992). These items were translated into Dutch for the pilot study (Tönis et
al., 2022).
The experiences of the participants with the intervention will be evaluated by
individual semi-structured (phone-based) interviews. The aim of the interviews
is to gain insight into the process of change during the intervention. The
interviews will be carried out by a trained junior-researcher.
In addition, participants will be asked to fill in the eight item
Client Satisfaction Questionnaire (CSQ-8) to measure satisfaction with the
intervention. The CSQ-8 aims to assess the satisfaction of users with (mental)
health services (Attkisson & Greenfield, 1994).The short length makes it
appropriate for mailed surveys (De Wilde & Hendriks, 2005). The eight items
will be scored from one to four and overall satisfaction will be expressed in a
mean over the eight items (De Wilde & Hendriks, 2005). A high internal
consistency of the CSQ-8 was found in a sample of 110 Dutch mental health
outpatient (De Brey, 1983) and 262 Dutch substance addicted patients (De Wilde
& Hendriks, 2005).
The interventionists will be asked to fill in a logbook for each
session in order to get insight into treatment fidelity. In the logbook,
questions on the performed exercises (e.g., whether exercises could be carried
out) and it will be asked if interventionists made changes to the treatment
protocol.
Background summary
Cardiovascular diseases (CVDs) are conditions of blood vessels and the heart,
such as strokes and heart attacks (National Health Service, n.d.; World Health
Organization [WHO], 2021). CVDs represented an estimated 32% of the deaths
globally in 2019 (WHO, 2021). In the Netherlands, every day an average of 100
people die as a result of CVD in 2020, representing 22% of national deaths
(Koop, et al., 2021). In addition, over 1.5 million Dutchmen suffered from CVD
in 2020 (Koop, et al., 2021). In 2017, 10.2 billion euros were spent on CVD
patients care, representing 11.7% of the healthcare costs in the Netherlands
(Plasmans, et al., n.d.).
In addition to the economic burden, CVDs also affect the mental health
of an individual patients. Depression and anxiety are common in CVD patients
(Celano, et al, 2016; Hare, et al., 2014). Around one in five CVD patients
experience a (major) depression (Celano and Huffman, 2011; Gehi, et al., 2005;
Rutledge, et al., 2006) or increased anxiety levels (Celano, et al., 2016).
Importantly, anxiety or depression are associated with poorer outcomes in CVD
patients. Depression is associated with mortality (Jiang, et al., 2001), more
days spent in hospital (Reese, et al., 2011), rehospitalisation (Jiang, et al.,
2001; Reese, et al., 2011), increased health care use (Rutledge, et al., 2006),
medication non-adherence (Gehi, et al., 2005), and more visits to the emergency
department (Reese, et al., 2011). Anxiety is associated with the recurrence of
cardiac events and mortality (Celano, et al., 2015; Roest, et al., 2010).
Mental well-being (subjective happiness and positive functioning) on
the other hand is associated with positive outcomes such as longevity, better
health behaviors and a reduction in the risk of a secondary event (Sin, 2016).
Mental well-being or health is not merely the absence of anxiety or depression,
but the presence of positive mental functioning (Keyes, 2002; Westerhof &
Keyes, 2010). For example, optimism is associated with a lower risk for
rehospitalisation (Huffman, et al., 2016; Scheier, et al., 1999; Tindle, et
al., 2012), increased depression treatment response (Tindle, et al., 2012), a
reduction in the risk of depressive symptoms (Rondaldson, et al., 2015), better
physical health status (Rondaldson, et al., 2015), more physical activity
(Huffman, et al., 2016), and healthy behavior such as vegetable and fruit
consumption and smoking cessation (Rondaldson, et al., 2015). In addition a
reduction of positive affect is found to be a predictor of a secondary event
(myocardial infarction) (Denollet, et al., 2007; Kim, et al., 2013) and death
(Denollet, et al., 2007). Purpose in life is associated with a significant
reduced risk of a secondary event (myocardial infarctions) (Kim, et al., 2013).
These findings suggest that increasing mental well-being and reducing
distress in CVD patients can contribute to better medical outcomes. In
addition, mental well-being can be seen as an indicator of positive functioning
and adaptation of CVD patients (Bohlmeijer & Westerhof, 2021; Sin, 2017).
Positive psychology interventions (PPIs) are interventions that aim to foster
positive behaviors, feelings and cognitions (Sin & Lyubomirksy, 2009) with the
aim to enhance mental well-being and reduce distress. Research suggests that
PPIs not only have positive effects on mental well-being but also on depression
(Bolier, et al., 2013; Carr, et al., 2021; Sin & Lyubomirksy, 2009), anxiety
and stress (Carr, et al., 2021). Carr et al. (2021) focused on the clinical
status of participants in their meta-analysis and found larger effects on
mental well-being, depression and strengths for clinical participants in
comparison to healthy participants. In addition, Brown, et al. (2019) found
positive effects of PPIs on anxiety in medical patients. These findings suggest
that clinical populations, including CVD patients, could potentially benefit
from PPIs. PPIs could improve mental well-being, depression and anxiety, which
might then lead to improvements in outcomes such as health behavior or
treatment and medication adherence.
PPIs can thus be implemented as prevention in the revalidation program
for CVD patients, especially for those with mild to moderate distress and lower
levels of mental well-being. However, PPIs to promote mental well-being are
lacking in the current Dutch revalidation program. Programs that are currently
implemented mainly target physical recovery (physical and relaxation
exercises), patient education (concerning CVD and lifestyle) and are aimed at
reducing distress with for example cognitive behavioral therapy or
stressmanagement (Hartstichting, n.d., Achttien, et al., 2011).
Several PPIs have been developed for CVD patients (e.g. Huffman, et
al., 2011; Redwine, et al., 2016), however none was implemented and evaluated
in the Dutch population. This raises questions concerning the fit in the Dutch
recovery program for CVD patients. Recently, an evidence-based, transdiagnostic
group PPI has been developed for people with mental or physical disorders. An
adaptation was made for people with CVDs: Living Well With Hearth Disorder.
This PPI aims to promote positive skills that promote mental well-being and
adaptation to and psychological recovery from a serious illness. The
feasibility and acceptability of the intervention have been evaluated in a
pilot-study (n = 5) at the ZGT-hospital. Participants were enthusiastic about
the quality of the intervention, with satisfaction being scored with 8.6/10
points, and recommendation with 8.8/10 points.
The current study aims to assess the effectiveness of this Dutch PPI as
part of the cardiac rehabilitation to increase mental well-being with a
Multiple Baseline Design (MBD), a type of Single Case Experimental Study Design
(SCED). A MBD can give a good and efficient assessment of the effects of an
intervention with limited resources and a limited number of patients (Tate &
Perdices, 2019). SCED *represents a rigorous scientific methodology that can
draw causal relations between interventions and behavior change* (Kazdin, 2009,
p. 16). In contrast to the between-group level (effectiveness) analysis of a
(large and expensive) Randomized Controlled Trial (RCT), the within-group level
analysis of a SCED can show the number of participants that were (clinically
important) affected by the intervention (Kazdin, 2019). A MBD was chosen
instead of a Randomized Controlled Trial because (1) participants act as their
own control group, therefore nobody will be withheld from the intervention as
is normally the case for the control condition and (2) a SCED requires a much
smaller sample size, but causal inferences can still be drawn. In comparison
with RCTs, SCEDs require strongly reduced resources and time, but still yield
strong evidence for the effects of interventions.
(voor bronnen zie het bijgevoegde protocol)
Study objective
To examine whether the Positive Psychology group intervention *Goed leven met
een hartaandoening* [Living well with heart disorder] is effective in
increasing mental well-being, ability to adapt, positive skills (e.g.
savouring, positive re-interpretation) and decreasing distress (anxiety and
depressive symptoms) of CVD patients.
Study design
A multiple baseline Single Case Experimental Design with a five to seven weeks
baseline phase, an eight week treatment phase and an eight week follow-up
phase.
Intervention
The intervention *Goed leven met een hartaandoening* consists of 8 group
sessions (6-8 participants) of 2 hours. This intervention is an adaptation of
the transdiagnostic, evidence based *Living well with bipolar disorder*
intervention. Each session focuses on a skill that promotes mental well-being,
e.g. self-compassion, knowing one*s strengths, optimism, savoring (Kraiss, et
al., 2018). A pilot study (n = 5) showed high acceptance and appreciation of
the intervention and reliable changes in personal recovery in four patients.
Study burden and risks
The intervention consists of eight guided group sessions combined with homework
(daily practice with the exercises). In addition, participants will be asked to
fill in one brief questionnaire each week, for five to seven weeks (depending
upon the condition they will randomly assigned to) during the baseline phase,
one brief questionnaire a week for eight weeks during the (eight week lasting)
intervention phase, and one brief weekly questionnaire for eight weeks after
the intervention ends, during the follow-up phase. No risks are foreseen based
on experiences with this intervention for other target groups (e.g. bipolar
disorder patients) and the pilot study of this intervention with the current
target group. In addition, participants may benefit from the study with an
increase in positive functioning and adaptation.
De Zul 10
Enschede 7522 NJ
NL
De Zul 10
Enschede 7522 NJ
NL
Listed location countries
Age
Inclusion criteria
1) diagnosis of heart failure, heart attack or recently undergone surgery due
to a heart disease with 2) sufficient (clinical) stability and physical
recovery (as indicated by the cardiologist and nurse specialist)
3) clear motivation to work on mental well-being and willingness to spend two
hours a week on homework
4) able to function in the group as indicated by the psychologist (e.g. being
able to speak and understand Dutch)
5) possessing a smartphone with internet access for data collection.
Exclusion criteria
1) current anxiety disorder (Mini International Neuropsychiatric Interview,
MINI; Van Vliet & De Beurs, 2007) or major depressive episode (MINI, major
depression domain)
2) current psychological or psychiatric treatment outside this study since this
can influence potential effects of the intervention
3) personal circumstances that interfere with attending to the course (e.g. an
addiction) as indicated by the psychologist,
4) limited life expectancy (< 2 years),
5) on waiting list for major surgery or other medical intervention,
6) insufficient Dutch language skills to follow the group sessions or complete
homework exercises.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82786.091.22 |