Main objective: To assess the effectiveness of MYSelf in comparison to care as usual in improving quality of life and symptom severity. Secondary objectives: 1) To investigate which characteristics of primary care professionals (General…
ID
Source
Brief title
Condition
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The physical component score of the Dutch version of the RAND-36 (measure of
health-related quality of life) will be used as our primary outcome.
Secondary outcome
Secondary outcomes are the RAND-36*s Mental component score, symptom severity,
psychological symptoms (asked with the 4DSQ), patient satisfaction, health care
utilization, and productivity loss.
Background summary
Medically Unexplained Symptoms (MUS) are physical symptoms that have existed
for more than several weeks and for which adequate medical examination has not
revealed any condition that sufficiently explains the symptoms. MUS are the
result of a complex individual interplay between biological, psychological, and
social factors. Psychotherapy reduces symptoms and improves quality of life,
but is only indicated for severe cases and not well accepted by patients. We
developed an e-Health system, Master Your Symptoms (MYSelf), to support general
practitioners in early detection and treatment of MUS. Based on patient*s
responses to online questionnaires, this system generates a treatment plan
consisting of a personal set of exercises and assignments to improve
self-management.
Study objective
Main objective:
To assess the effectiveness of MYSelf in comparison to care as usual in
improving quality of life and symptom severity.
Secondary objectives:
1) To investigate which characteristics of primary care professionals (General
Practitioners (GPs), and General practice mental health workers (GP-MHWs; In
Dutch: POH-GGZ)) predict effectiveness of MYSelf; 2) To investigate which
patient characteristics predict effectiveness of MYSelf; 3) To investigate the
cost-effectiveness of MySelf in comparison to care as usual; 4) To investigate
whether MYSelf is acceptable to patients and primary care professionals (GPs
and GP-MHWs) and to assess therapeutic change mechanisms; 5) To investigate
which mechanism predicts treatment outcomes.
Study design
Pragmatic randomized controlled trial.
Intervention
The research group participates in MYSelf, guided by the GP and GP mental
health worker; the control group receives care as usual from the GP.
Study burden and risks
Since the questionnaires are actually part of the routine outcome monitoring,
we kept the extra burden for filling out questionnaires as limited as possible.
Since all exercises in our eHealth system are originally self-help exercises
and participating patients in the intervention group are supervised by their
GP/GP-MHW, we assume that the risks of our intervention are negligible.
Hanzeplein 1
Groningen 9712GZ
NL
Hanzeplein 1
Groningen 9712GZ
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18 years.
2.Presenting with MUS. In line with the guidelines provided by the Dutch
College of General Practitioners, MUS are defined as *physical symptoms that
have persisted for more than several weeks and for which adequate medical
examination has not revealed any condition that sufficiently explains the
symptoms* (Olde Hartman et al., 2013). Since the duration of an episode and the
moment of presentation might vary per symptom, the GP will judge whether this
criterion is met.
3. Main symptom concerns pain, gastro-intestinal complaints or fatigue.
4. Capable of understanding questionnaires and exercises: adequate command
of the
Dutch language, no major cognitive or visual impairment.
5. In possession of an e-mail account and a personal computer, laptop or tablet
with internet connection. These will be needed to access the study website,
fill out questionnaires, and receive personalized feedback.
Exclusion criteria
1. Currently treated by a mental health professional with psychotherapy.
2. Presence of severe anxiety, depression, or presence of post-traumatic stress
syndrome, that needs treatment according to the GP. Thus, if the GP deviates
from the GP guidelines with good reason, this is not a reason for exclusion.
Also, mild anxiety or depression is not an exclusion criterion.
3. Pregnancy.
4. Engaged in a legal procedure concerning disability-related financial
benefits.
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 | NL61185.042.17 |