We expect that psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms improves daily functioning, decreases severity of the complaints symptoms and the care consumption, while lowering costs.
ID
Bron
Verkorte titel
Aandoening
Medically unexplained symptoms (MUS)
Somatisch onvoldoende verklaarde lichamelijke klachten (SOLK)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary clinical outcome is patients’ level of specific functioning and disability measured with the patient-specific functional scale (PSFS). <br>
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The primary outcome measure for the economic evaluation is quality of life assessed by the SF-6D, which will be derived from the SF-36. Health care costs, medical consumption and work limitations will be assessed with the Medical Consumption Questionnaire (iMCQ) and work limitations with the Productivity Cost Questionnaire (iPCQ).
Achtergrond van het onderzoek
Medically unexplained symptoms are common in primary and secondary care and associated with large societal costs, including both health care costs and costs of lost productivity. Patients have lower quality of life. Furthermore, these patients are often dissatisfied with the medical care they receive. Psychosomatic therapy is a physical (multi-component) treatment administered by physical and exercise therapists with special interest in MUS. It is a stepped-care and tailor-made approach in which (psycho)education, relaxation therapy, mindfulness, cognitive behavioural therapeutic interventions and activating exercise therapy are key elements.
We will evaluate the effects and costs of psychosomatic therapy in primary care for patients who frequently attend the GP for MUS in improving symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care.
The study consists of two parts. Part 1; Effect and economic evaluation: We will perform a randomized cost-effectiveness trial in primary care. Patients will be randomized into intervention (psychosomatic therapy in addition to usual care) or control condition (usual care alone). All patients will be followed for one year and will be asked to complete questionnaires at baseline and at 4 and 12 months follow-up. Part 2; Process evaluation: We will perform a quantitative and qualitative (sub)study with both therapists and patients; questionnaires for participating therapists and semi-structured interviews with participating patients in the intervention group.
We expect that psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms improves daily functioning, decreases severity of the symptoms and the care consumption, while lowering costs.
Doel van het onderzoek
We expect that psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms improves daily functioning, decreases severity of the complaints symptoms and the care consumption, while lowering costs.
Onderzoeksopzet
Baseline, at 4 and 12 months
Onderzoeksproduct en/of interventie
Patients randomized to the intervention group will be invited to attend 6 to12 sessions, depending on the severity of the complaints, of tailor-made psychosomatic therapy, lasting 45 minutes each. These sessions are additional to the usual care for patients with MUS provided by their GP and other healthcare professionals.
Psychosomatic therapy is administered by psychosomatic therapists. These are physical and exercise therapists with special interests in MUS, respectively from the Dutch Association for Psychosomatics in Physical Therapy (NFP) and the Dutch Association for Exercise Therapists (VvOCM). Psychosomatic therapy has been developed using the well-known concept of the biopsychosocial model in which illness is viewed as a result of interacting mechanisms at the biomedical, interpersonal and environmental levels. Psychosomatic therapy implies that patients’ symptoms, illness beliefs, anxiety, concerns, illness behaviour and social environment are addressed.
It is a multi-component, stepped-care and tailor-made approach and includes the following modules: (1) psycho-education, (2) relaxation therapy and mindfulness, (3) cognitive behavioural approaches and (4) activating therapy. Psychosomatic therapy is captured in a treatment protocol which allows the therapists to change the intensity, frequency and order of the four modules in order to deliver a tailor-made approach. In the psychosomatic therapy sessions the therapist together with the patient explores and treats somatic symptoms by integrating the physical, cognitive, emotional, behavioural and social dimensions of the symptoms presented. During the therapy, underlying beliefs and psychosocial factors which influence the perceived somatic symptoms, are identified in order to give patients (experienced) insight in the interaction of these factors with the somatic symptoms. The aim of the intervention is empowerment of the patients to regain control over their own health.
Patients in the control group will receive usual care provided by the GP and other health care professionals. The usual care for patients with MUS has been described in the guideline on the management of MUS of the Dutch College of General Practitioners.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
The target population includes primary care patients aged 18-80 years who frequently, i.e. twice or more in the last 3 months, consult their GP for MUS. Patients should have a PHQ-15 score of >/= 5.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion criteria are receiving palliative care, having a severe psychiatric disorder (i.e. psychosis-related disorders, dementia and bipolar disorder), mental retardation, visual impairment, illiteracy, insufficient understanding of the Dutch language.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL7157 |
NTR-old | NTR7356 |
Ander register | 843001802 : ZonMW projectnummer |