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Psychophysiological stress mechanisms in chronic inflammatory diseases.


- candidate number2952
- NTR NumberNTR1193
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-dec-2007
- Secondary IDs15023 (METC) 
- Public TitlePsychophysiological stress mechanisms in chronic inflammatory diseases.
- Scientific TitlePsychophysiological stress mechanisms in chronic inflammatory diseases.
- ACRONYMpsychophysiology, stress, chronic inflammatory disease,
- hypothesisParticularly in patients at risk, the stress-management intervention affect self-reported, immune and neuroendocrine indicators of stress reactivity.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteriaPatients diagnosed with rheumatoid arthritis.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2007
- planned closingdate1-nov-2009
- Target number of participants64
- Interventions1. Stress management intervention + usual care (intervention group);
2. Usual care (control group).
- Primary outcomePsychological distress.
- Secondary outcomeCortisol and IL-6.
- Timepoints3 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.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. A.W.M. Evers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.W.M. Evers
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds
- PublicationsN/A
- Brief summaryThere 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.
- Main changes (audit trail)
- RECORD17-dec-2007 - 16-mei-2010


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