No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid arthritis.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psychological distress.
Secondary outcome
Cortisol and IL-6.
Background summary
There is increasing evidence for the idea that psychological stress factors can influence chronic inflammatory diseases, such as RA. These relationships are assumed to be (at least partly) mediated by immune and neuroendocrine function. In addition, our and other previous work suggests that stress mechanisms affecting disease activity and immunological parameters are primarily evident in patients with a psychological risk profile for stress.
The effects of a short-term stress-management intervention are investigated in 64 RA patients. It is expected that, particularly in patients at risk, the stress-management intervention affect self-reported, immune and neuroendocrine indicators of stress-reactivity, which in turn affect disease activity and physical symptoms of pain. The study might contribute to improved diagnosis and treatment of RA and other chronic inflammatory diseases.
Study objective
Particularly in patients at risk, the stress-management intervention affect self-reported, immune and neuroendocrine indicators of stress reactivity.
Study design
3 measurement points for the intervention group:
1. T1: at study entry (i.e. 1 week prior to treatment);
2. T2: 1 month follow-up (i.e. 1 week post treatment);
3. T3: 3 months follow-up.
3 measurement points for the control group:
1. T1: at study entry;
2. T2: 1 month follow-up;
3. T3: 3 months follow-up.
Intervention
1. Stress management intervention + usual care (intervention group);
2. Usual care (control group).
PO Box 9555
A.W.M. Evers
Leiden 2300 RB
The Netherlands
+31 (0)71 527 3627
a.evers@fsw.leidenuniv.nl
PO Box 9555
A.W.M. Evers
Leiden 2300 RB
The Netherlands
+31 (0)71 527 3627
a.evers@fsw.leidenuniv.nl
Inclusion criteria
Patients diagnosed with rheumatoid arthritis.
Exclusion criteria
1. Severe physical comorbid conditions (e.g. psoriatic arthritis, malignancy, renal insufficiency);
2. Psychiatric disturbances that interfere with the study protocol;
3. Pregnancy;
4. Non-Dutch speakers.
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 |
---|---|
NTR-new | NL1150 |
NTR-old | NTR1193 |
Other | : 15023 (METC) |
ISRCTN | ISRCTN wordt niet meer aangevraagd |