The present study will test the effect of MBSR on RA in comparison to cognitive behavioral therapy (CBT) and a no-treatment control group. It is hypothesized that Mindfulness will be at least as effective in changing quality of life, psychological…
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Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The five primary endpoints of the current study are quality of life,
psychological well-being, pain acceptance, stress, and physical functioning.
Standard questionaires will be used to measure these endpoints.
Secondary outcome
Medical variables include time since diagnosis (from medical file), disease
activity at baseline, co-morbidity (from medical file), and use of medication,
in particular anti-depressant medication. Socio-demographic variables (obtained
by self report at the baseline) include age, gender, education level, and
marital status. Psychological variables (obtained by self report) include type
D personality, mindfulness, and social desirability.
Background summary
Rheumatoid arthritis (RA) is a chronic, unpredictable and one of the most
common autoimmune diseases (Symmons, 2002; van Riel, 1996; Krol, 1996). It is
estimated that the prevalence of RA is about 1%, making it a common condition.
RA is typically a progressive illness that has the potential to cause joint
destruction and functional disability. Disability has a significant effect on
quality of life as experienced by people, as well as on depression and anxiety
(Symmons, 2002).
Until now, the most common types of intervention in psychological treatment for
RA-patients were self-management programmes and cognitive-behavioral therapy.
Both approaches emphasize learning new skills helpful in managing one's
disease.
Mindfulness meditation was initially introduced as a clinical intervention for
conditions such as chronic pain and anxiety in 1979. It is currently taught and
studied in many clinical trials as the Mindfulness-Based Stress Reduction
Program (MBSR)
Study objective
The present study will test the effect of MBSR on RA in comparison to cognitive
behavioral therapy (CBT) and a no-treatment control group. It is hypothesized
that Mindfulness will be at least as effective in changing quality of life,
psychological and social functioning, pain intensity and pain acceptance,
functional ability and disease activity and stress as CBT and more effective
than no therapy (the waiting-list control condition), evaluated at
post-treatment and in follow up. Furthermore, the current study hypothesizes
that MBSR will be at least as effective in changing the complaints of type D
personality RA patients in comparison with non-type D personality RA patients.
Thus, the moderating effect of Type D personality will be examined.
Study design
The research design is a randomized controlled trial (RCT). The study time is 2
years, during which patients can be included in the study. Both CBT and MBSR
are administered in patient groups en will consist of 8 weekly gatherings. A
third group, consisting of patients on the waiting list, acts as the control
group. Patients are blindly assigned to one of the therapy groups.
The baseline measurement is defined by the moment of the start of the therapy
or wait list. At this time, they will be asked to fill in a number of
questionnaires at the hospital to assess the baseline measurements. Additional
medical information will be collected in the medical file by the researcher.
Follow-up moments are planned, at two months after the intervention (T1), and
at 6 months after the intervention (T2).
Intervention
See ''study design''.
Study burden and risks
Patients are asked, in addition to filling in a number of questionaires, to
participate in an 8 weeks therapy which will teach them to cope with their
complaints. Scientific studies have shown that both forms of therapy have a
postive effect on patients' complaints, both for this and other patient
populations. There are no risks attached and from own experience and other
studies it is known that the additional demands are not problematic, since
patients will notice the beneficial effects right from the start of the
therapy.
De Run 4600 (locatie Veldhoven)
5504 DB Veldhoven
NL
De Run 4600 (locatie Veldhoven)
5504 DB Veldhoven
NL
Listed location countries
Age
Inclusion criteria
Patients with RA diagnosis received at least one year ago and no more than five years ago will be included. Sufficient understanding of written and spoken Dutch is required.
Exclusion criteria
Exclusion criteria are: age over 80; chronic severe psychiatric conditions (e.g. psychosis or a personality disorder); previously participated in a MBSR program.
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 | NL31677.015.10 |
OMON | NL-OMON28153 |