Referring to the previous CMO approved research proposal (2004/222), in this study the effects of a short-term stressor and a stress-reducing intervention on neuroendocrine, immune and self-reported indicators of stress reactivity in patients with…
ID
Source
Brief title
Condition
- Joint disorders
- Cornification and dystrophic skin disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psychological distress (anxiety and depression)
Secondary outcome
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
Background summary
There is increasing evidence for the idea that psychological stress factors can
influence chronic inflammatory diseases, such as rheumatoid arthritis (RA) and
psoriasis (PS). These relationships are assumed to be (at least partly)
mediated by immune and neuroendocrine function. Despite preliminary evidence,
the limited research revealed inconsistent findings, particularly regarding
immune and neuroendocrine mediation. 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.
Referring to the previous CMO approved research proposal (2004/222), the
present experimental project is aimed at elucidating the effects of short-term
stress and a short-term stress management intervention in a group of 64 RA
patients and 64 PS patients (high risk and low risk). It is expected that, only
in patients at risk, short-term stress and 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 and itching.
Study objective
Referring to the previous CMO approved research proposal (2004/222), in this
study the effects of a short-term stressor and a stress-reducing intervention
on neuroendocrine, immune and self-reported indicators of stress reactivity in
patients with RA and PS will be investigated. Special attention will be paid to
patients psychologically at risk for stress.
Study design
This study is composed of two parts: a stress experiment and a stress
management intervention.
Stress experiment:
During 4 months, 128 patients (64 RA and 64 PS patients) will visit the Radboud
hospital 3 times for an experimental stress experiment (Trier Social Stress
Task). During these visits, different clinical, physiological and self-reported
variables will be assessed. Additionally, for matching control data 32 healthy
participants will participate in the stress experiment once.
Stress management intervention:
In a randomized controlled trial half of all RA and PS patients with
respectively a high and low risk profile for stress (2 times 32 patients) will
receive a stress management intervention. This intervention takes place in
between the first and second visit for the stress experiment. Patients in the
intervention group will visit the hospital twice every week during one month.
Additionally, they have some homework assignments (15 minutes daily).
Intervention
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 intervention. Participants will
visit the Radboud hospital 8 times (2 sessions a week during 4 weeks; 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 and PS patients and all healthy
controls) will not be offered the stress management intervention.
Study burden and risks
There are no risks involved for the participants of this study, only investment
in time. The design of this study is necessary to elucidate the role of
psychophysiological stress mechanisms in the chronic inflammatory diseases RA
and PS. In the long run, this study might contribute to the improvement of
diagnostics and treatment of chronic inflammatory diseases.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
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
Severe physical comorbid conditions (e.g. psoriatic arthritis, malignancy, renal insufficiency)
Psychiatric disturbances that interfere with the study protocol
pregnancy
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 |
---|---|
CCMO | NL15023.091.06 |