No registrations found.
ID
Source
Health condition
rheumatoid arthritis,
mindfulness-based stress reduction, MBSR, cognitive behavioral therapy, CBT
Sponsors and support
Medical Psychology at the Maxima Medisch Centrum (MMC) where I work as a
clinical psychologist trainee. Also the regional arthritis center (RRC)
plays an important part. In addition, the METC (Medical Ethical Examination
Committee) of the MMC is involved in checking the progress and reporting of
the research. At a higher level, Maxima Medisch Centum is the
sponsor/executive.
Medical Psychology at the Maxima Medisch Centrum (MMC) in cooperation with
the RRC, and at a higher level the MMC itself.
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.
The primary outcome will be determined by letting participants fill in
questionnaires at pre-determined times. In particular, on several occasions
the DAS28 score will be measured in order to measure disease activity. The
DAS28 is measured in any event several times per year for RA (Rheumatoid
Arthritis) patients.
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
This study is concerned with the effects of Mindfulness interventions for Rheumatoid arthritis (RA) patients, in comparison with Cognitive Behavioral Therapy. An important covariant variable may be the presence or absence of a type D personality in a patient.
Aspects of RA and common medical treatments are discussed, as well as a number of non-pharmacological treatments including Cognitive-behavioral Therapy (CBT) and Mindfulness-based Stress Reduction (MBSR).
The research proposal concerning Mindfulness and RA is discussed, with details regarding the design and procedure, the patients, and expected outcome.
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. In addition, it is expected that on some aspects the MBSR intervention may be even more effective than CBT, specifically regarding higher pain acceptance, lower impact of pain on one's life and higher positive affect.
Study design
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 rheumatologist. Follow-up moments are planned, at two months after the intervention (T1), and at 6 months after the intervention (T2).
Intervention
The research is set up as a randomized controlled trial (RCT). The research
period is two years, during which time patients can be admitted to the
program. Both CBT (Cognitive Behavioural Therapy) and Mindfulness Based
Stress Reduction (MBSR) therapies are provided for patient groups, and will
comprise 8 weekly sessions. A third group, consisting of waiting list
patients, will function as the control group. Patients will be blindly
assigned to one of the groups.
As part of the mindfulness therapy, patients will be taught to experience
events in a non-judgemental way. Patients will learn to be more aware of
their emotions and to better regulate these emotions, by living in the
here and now. They will be better able to effectively deal with their
disease.
In the cognitive behavioural therapy, patients will be asked to be more
aware of their thoughts concerning the disease and their coping with the
disease. They will learn to change these thoughts so as to deal more
effectively with disease-related complaints such as pain.
In the control (waiting list) group, patients will only receive the
standard care.
De Run 4600
M.W.A.C. Jong, de
Veldhoven 5504 DB
The Netherlands
m.w.a.c.de.jong@gmail.com
De Run 4600
M.W.A.C. Jong, de
Veldhoven 5504 DB
The Netherlands
m.w.a.c.de.jong@gmail.com
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
1. Age over 80;
2. Chronic severe psychiatric conditions (e.g. psychosis or a personality disorder);
3. Previously participated in a MBSR program.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3311 |
| NTR-old | NTR3458 |
| CCMO | NL31677.015.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34919 |