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Psychophysiological stress mechanisms in chronic inflammatory diseases; an experimental study

Psychophysiological stress mechanisms in chronic inflammatory diseases; an experimental study - Psychophysiological stress mechanisms in RA and PS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30321
Enrollment
160
Registered
2007-06-12
Start date
2007-01-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis rheumatoid arthritis

Interventions

The intervention study is a randomized controlled trial. Half of all participants with respectively a high and low risk profile for stress will be asked to participate in a stress management interve
ca. 1 hour each session). During these visits participants are offered relaxation therapy. Additionally, they will get homework assignments (15 minutes each day). The control groups (half of all RA

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with rheumatoid arthritis (Arnett et al., 1988) or psoriasis (van de Kerkhof, 2003). This criterion is not applicable to healthy controls 18 years or older Informed consent

Exclusion criteria

Exclusion criteria: Severe physical comorbid conditions (e.g. psoriatic arthritis, malignancy, renal insufficiency) Psychiatric disturbances that interfere with the study protocol pregnancy non-Dutch speakers

Design outcomes

Primary

MeasureTime frame
Psychological distress (anxiety and depression)

Secondary

MeasureTime frame
Fysiologic assessments: concentrations cortisol, ACTH, IL-1, IL-6, IL-18, MIF en TNF-alfa Other measurements: - Clinical assessment of disease activity (DAS or PASI) - Autonomous stress response (heart rate variability and skin conductance) - Self-reported variables (using standardized questionnaires) such as self-reported disease activity, physical symptoms (f.e. pain, itching, fatigue), psychological risk factors and stressors

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)