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van CCT (UK)

van CCT (UK)

Online self-management in fibromyalgia

- candidate number26709
- NTR NumberNTR6267
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-feb-2017
- Secondary IDsNL58130.058.16 P16.230
- Public TitleOnline self-management in fibromyalgia
- Scientific TitleAn online self-management intervention for patients with fibromyalgia – an RCT
- hypothesisTo study the effectiveness of the online self-management intervention in patients with fibromyalgia.
- Healt Condition(s) or Problem(s) studiedFibromyalgia, Selfmanagement, E-health, Chronic pain
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-jul-2017
- planned closingdate31-dec-2018
- Target number of participants70
- InterventionsThe 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.
- Primary outcomeThe primary effect will be determined by comparing the VAS pain coping scores after the intervention between the waitlist control group and intervention group, corrected for baseline VAS pain coping scores.
- Secondary outcomeAs 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.
- TimepointsPrimary and secondary endpoints will be measured at baseline, after 3 months, 4,5 months and 6 months.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Leiden University
- Funding
(Source(s) of Monetary or Material Support)
Innovatiefonds zorgverzekeraars
- Publications
- Brief summaryFibromyalgia 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.
- Main changes (audit trail)
- RECORD15-feb-2017 - 20-aug-2017

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