To study the effectiveness of the online self-management intervention in patients with fibromyalgia.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
fibromyalgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be pain coping, measured with a VAS score.
Secondary outcome
As secondary outcomes, a number of other psychological and physical outcome
measures will be assessed (e.g., HR-QoL, well-being, pain impact on daily life,
pain cognitions), as well as quality of the therapeutic relationship and
cost-effectiveness of the intervention.
Background summary
Fibromyalgia has a high clinical burden, as reflected by considerable pain,
decreased strength and mobility, physical disability, and an often decreased
health-related quality of life (HR-QoL). Self-management factors related to
physical and psychosocial adjustment, such as patients* perceptions about their
disease and coping, play an important role in HR-QoL and functional ability in
patients with chronic diseases, such as fibromyalgia. Improving capacities of
patients in managing a chronic condition is increasingly recognized as
important in the treatment of (somatic) conditions and becomes more common in
clinical practice and research. In this study, the effect of an online
self-management intervention focusing on coping skills related to chronic pain
in comparison to a waitlist control condition is studied.
Study objective
To study the effectiveness of the online self-management intervention in
patients with fibromyalgia.
Study design
An RCT will be performed, in which 35 participants will be randomized to the
online self-management intervention and 35 participants to a waitlist control
group. Baseline, post-intervention, 6-week, and three-month follow-up
questionnaires will be used to measure primary and secondary outcomes.
Intervention
The intervention is based on cognitive-behavioral methods. It starts off with a
face-to-face introduction consultation in which personal goals for the
intervention are set. Subsequently, the tailored self-management intervention
will be offered via an online program. The intervention consists of six modules
containing pain education, practical assignments, relaxation training, and
registrations. The first and last modules are an introductory and closure
module; in between are four modules aimed at learning how to cope with the
consequences of a chronic condition in daily life. The modules focus on (1)
activity, (2) mood, (3) thoughts, and (4) the social environment. At least once
a week, participants receive feedback on the assignments and motivational
support from a psychologist, by means of text messages in a secured mail box in
the online program. After finishing the online program, patients will be
approached by their treating psychologist for two booster sessions via
telephone. In these booster sessions it will be evaluated how the patient
further attained his/her pre-set goals for the intervention. Strategies to
strenghten the achieved results will be discussed. The booster sessions will
take place 1 month and 2,5 months after finishing the online program.
Study burden and risks
In the waitlist control condition, patients will receive the intervention after
the intervention ends in the intervention group (after 6 months). In the
intervention group patients will be offered an internet-based self-management
intervention, which potentially improves their pain coping and other
psychological and physical outcomes. No risk is involved with participation in
this study. The only burden for participants is investment of time.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with fibromyalgia, as previously confirmed by their treating GP or
a medical specialist
- Pain complaints with a minimal duration of 3 months
- Minimum age of 18 years
- Fluent in Dutch language
- Able to give informed consent
- Own a computer with internet access
Exclusion criteria
- Difficulties in (written) communication (e.g., due to analphabetism)
- Severe physical and psychiatric comorbidities that interfere with the study
protocol, such as psychosis, addiction, suicidal ideation
- On-going psychological treatment elsewhere
- Participation in other clinical trials
- Pregnancy
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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
In other registers
Register | ID |
---|---|
Other | 6267 |
CCMO | NL58130.058.16 |
OMON | NL-OMON28775 |