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van CCT (UK)

van CCT (UK)

Effect of mindfulness on patients with rheumatoid arthritis: A controlled effect study.

- candidate number12278
- NTR NumberNTR3458
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2012
- Secondary IDsNL31677.015.10 CCMO
- Public TitleEffect of mindfulness on patients with rheumatoid arthritis: A controlled effect study.
- Scientific TitleEffect of mindfulness on patients with rheumatoid arthritis: A controlled effect study.
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Cognitive behavior therapy, Mindfulness-based stress reduction
- Inclusion criteriaPatients 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 criteria1. Age over 80;
2. Chronic severe psychiatric conditions (e.g. psychosis or a personality disorder);
3. Previously participated in a MBSR program.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 29-apr-2010
- planned closingdate1-dec-2012
- Target number of participants120
- InterventionsThe 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.
- Primary outcomeThe 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 outcomeMedical 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.
- TimepointsThe 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).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator Maxima Medical Center, Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center, Regional arthritis center (RRC)
- PublicationsNo publications yet.
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD23-apr-2012 - 17-jun-2012

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