With this pilot feasibility study, the feasibility of and satisfaction with an eHealth and serious gaming training based on psychological expectancy mechanisms are evaluated.
ID
Source
Brief title
Condition
- Other condition
- Autoimmune disorders
- Cornification and dystrophic skin disorders
Synonym
Health condition
Het onderzoek wordt uitgevoerd onder patiënten met chronische aandoeningen die gepaard gaan met jeuk (zoals psoriasis of eczeem) en/of pijn (zoals reumatoïde artritis of fibromyalgie), en onder gezonde mensen.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters of this pilot feasibility study are the feasibility
of the online intervention satisfaction with the online intervention and the
satisfaction with the intervention, assessed by questionnaires (see page 19 of
the protocol for measurement details).
Secondary outcome
Not applicable.
Background summary
Studies show that expectations about health and disease may directly and
positively affect health and treatment outcomes, for example by inducing
anti-inflammatory effects. In this project, knowledge on the effects of
implicit and explicit expectancy mechanisms such as conditioning and verbal
suggestions is applied in a psychological eHealth and serious gaming
intervention aimed to optimize health outcomes. In this project, a prototype of
this intervention will be further refined and improved. In phase 2 (see CME
submission NL58186.058.16), the intervention will be examined regarding its
functionality and usability. In the next phase (phase 3, described in this CME
submission), the improved intervention will be subjected to pilot feasibility
testing.
Study objective
With this pilot feasibility study, the feasibility of and satisfaction with an
eHealth and serious gaming training based on psychological expectancy
mechanisms are evaluated.
Study design
Pilot study to evaluate the feasibility of and satisfaction with the newly
developed eHealth and serious gaming training.
Intervention
Both the healthy volunteers and the patients with a chronic pain or itch
condition will participate in a psychological (non-pharmacological) eHealth and
serious gaming training directing at optimizing health outcomes. The
intervention has a duration of 6 to 12 weeks and is based on cognitive
behavioural treatment in combination with automatic and conscious expectancy
learning principles (see page 15 of the protocol for intervention description).
Study burden and risks
There is a negligible risk involved with participation in this study. The
burden for participants consists of a time investment of two times
approximately 45 minutes for the questionnaire assessment before and after the
intervention, 1 hour for the face-to-face appointment with the therapist, and a
time investment of approximately 15-30 minutes per day during the 6-12 week
intervention. There are no direct benefits for subjects participating in this
study. The major contribution of this study is that an innovative
non-pharmacological treatment aimed at optimizing health outcomes without
pharmacological drugs could be useful as an addition, or ultimately replacement
of, current drug treatments. This may lead to new therapeutic possibilities for
patients with chronic somatic conditions requiring long-term pharmacological
treatment.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
For healthy volunteers:
- age * 18 years
- sufficient understanding of the Dutch language;For patients with a chronic pain or chronic itch condition:
- age * 18 years
- sufficient understanding of the Dutch language
- confirmed diagnosis of chronic pain condition or chronic itch condition
Exclusion criteria
For healthy volunteers:
- confirmed diagnosis of chronic pain condition or chronic itch condition
- severe physical or mental conditions (e.g., malignancy, psychosis, DSM-V diagnosis [American Psychiatric Association, 2013]) that interfere with the study protocol
- pregnancy;For patients with a chronic pain or chronic itch condition:
- severe physical or mental conditions (e.g., malignancy, psychosis, DSM-V diagnosis [American Psychiatric Association, 2013]) that interfere with the study protocol
- pregnancy
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL58192.058.16 |