Primary objective:Are coping style and quality of life different in patients receiving PST from patients receiving standard care after the intervention, after 6 months and after 12 months? Secondary objectives:1. Are amount of health careā¦
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are differences in coping style and quality of
life between patients in the intervention and control group.
Secondary outcome
Secondary outcome measures are differences in health care consumption,
depression, social participation and executive functioning between patients in
the intervention and control group. Another secondary outcome measure is the
cost-effectiveness of the intervention.
Background summary
In the Netherlands, 41.000 people suffer stroke each year. Over 3% of total
health care costs are related to the treatment of stroke. Therefore, stroke is
an important social problem. The question arises as how quality of life can be
optimized after stroke, in order to minimize health care consumption and
control the costs.
The average value stroke patients assign to quality of life is much lower than
the average value assigned by a healthy reference population. Coping style is
considered an important psychosocial factor with regard to quality of life of
stroke patients. Coping style refers to the preferred style of dealing with
different situations. By means of intervention coping styles can be influenced.
Furthermore, stroke patients make less use of active, problem-oriented coping
styles compared to other brain damaged patients. Consequently, it is important
to investigate if coping style as well as quality of life can be improved
through intervention. This can possibly be accomplished by increasing insight
and teaching skills to solve problems actively in threatening situations.
Problem Solving Therapy (PST) is such an intervention.
Patients receiving PST are expected to learn a more effective coping style and
consequently have a better quality of life than patients in the controlgroup.
PST has been proven effective in other patient populations. In stroke patients,
incidence of depression is shown to decrease after PST. Effects on coping style
and quality of life have not been investigated yet. Furthermore, we will
investigate if the therapy will be effective in an open group design, instead
of a closed design, whereby the therapy will be implemented more easily in the
standard rehabilitation treatment. In an open, continuous group patients can
join the group every moment. This design has not been investigated earlier in
PST. In this study, we want to add the therapy to standard care just before the
moment stroke patients finish their rehabilitation program and are thrown on
their own resources. This is the moment where a relapse in quality of life is
frequently observed, because patients cannot ask their therapists for help
anymore. The cost-effectiveness of PST will be assessed as well. We expect
patients to cope better with stressful situations after receiving PST, through
which quality of life will increase and health care consumption will decrease,
resulting in a reduction in health care costs.
Study objective
Primary objective:
Are coping style and quality of life different in patients receiving PST from
patients receiving standard care after the intervention, after 6 months and
after 12 months?
Secondary objectives:
1. Are amount of health care consumption, depression, social participation and
executive functioning in patients receiving PST different from patients
receiving standard care?
2. Is Problem Solving Therapy a cost-effective intervention in stroke patients?
Study design
A randomized controlled trial with one year follow-up will be performed to
assess the effectiveness of PST. Patients will be randomized between the
intervention and control group. Patients in the interventiongroup will receive
PST in addition to standard care. Patients in the controlgroup will receive
standard care only. Before the intervention, after the intervention, 6 months
and 12 months later patients the outcome variables will be measured.
Intervention
Patients randomly assigned to the treatment condition will receive additional
therapy at the end of the usual rehabilitation program for stroke patients.
Patients assigned to the control condition will receive standard care only.
The therapy is based on Problem Solving Therapy. PST is a widely used
intervention based on a common model of coping with stress. This model states
having a chronic disease (suffering and rehabilitating from stroke in this
case) causes some stressful daily problems. These problems increase the chance
of experiencing psychological stress and depressive feelings. Therefore, the
aim of PST is to improve skills to cope with the stressing daily problems in
life after suffering stroke. The intervention is empirically validated and
proven effective in other chronically ill patients. The therapy for stroke
patients will consist of 8 groupsessions, with a maximum of 6 participants.
Solving problems will be structured:
1. defining problems
2. generating alternative solutions for a problem
3. considering the possible consequences of a solution systematically and
selecting the best solutions
4. evaluating the results after implementation of the solution.
Study burden and risks
The burden of Problem Solving Therapy for patients in the intervention group
will be 1 groupsession each week for 1 hour, during 8 weeks in the
rehabilitation centre. Participating in the study does not bring any risks. The
only possible negative consequence of the therapy is tiredness, wherefore the
patient can be advised by the therapist.
At four timepoints, patients in both groups will be asked to fill in
questionnaires with regard to coping style, quality of life, level of
functioning, personality characteristics, depression, participation and health
care consumption. Furthermore, patients will be given some neuropsychological
tests with regard to attention, memory and executive functioning. The first
measurement will take about 2 hours, the last 3 measurements will take about
1,5 hours.
Westersingel 300
Rotterdam 3015 LJ
NL
Westersingel 300
Rotterdam 3015 LJ
NL
Listed location countries
Age
Inclusion criteria
stroke
between 18 and 75 years of age
treated at the out-patient rehabilitation clinic
able to follow psychotherapy during one hour every week
Exclusion criteria
progressive neurological disorder
life-expectancy less than 12 months
insufficient understanding of Dutch
drug- or alcoholabuse
subdural haematoma
moderate to severe aphasia (as measured by the token test)
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 | NL34056.078.10 |