Psychosomatic Therapy, Feasibility and Cost Analysis
Psychosomatic Therapy, Feasibility and Cost Analysis
Medically unexplained symptoms (MUS) are a common and important problem in primary care.
 Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their
 symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful
 tests, referrals and treatment. Evidence indicate that specific interventions for patients
 with MUS, such as reattribution therapy and cognitive behavioural therapy are of limited
 help. According to experts in this field a multi-component approach is most helpful for these
 patients.

 This pilot trial aims to test the systematic identification of eligible patients, to assess
 the acceptability of the intervention and to estimate potential treatment effects for a
 larger trial.

 It's a randomised pilot study consisting of patients with MUS in primary care. Patients will
 be randomized to intervention (usual care and additional psychosomatic therapy) or control
 condition (usual care alone). Patients will be followed for one year.

 Participants are patients consulting their GP more than once with MUS and in which the GP
 presumes that psychosocial distress is an underlying cause.

 The intervention is the psychosomatic therapy delivered by a psychosomatic therapist,
 consists of a combination of information and education, relaxation therapy and mindfulness,
 cognitive approaches and activating therapy. This multi-component approach is captured into a
 protocol in which therapists are able to modify the treatment in order to deliver a
 tailor-made treatment for patients with MUS.

 Primary outcome measures are: the number of patients identified and recruited, perceived
 symptom severity, measured on a Visual Analogue Scale (VAS) and patients' self-rated symptoms
 of distress, depression, anxiety and somatization (4DSQ: The Four Dimensional Symptom
 Questionnaire). Other primary outcome measures are the time needed to include the eligible
 patients, the number of withdrawals in the intervention and control group, compliance in the
 therapy group and the number of patients who complete the questionnaires.

 Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation
 List), physical and mental health status and quality of life (SF-36), and level of
 functioning (MAF: measure of general functioning). Patient satisfaction with the received
 therapy is rated on a 5-point Likert-type scale. Medical consumption will be measured by the
 Cost Diary for medical consumption.
Recruitment and signed informed consent:Participating GPs (n=6) were asked to enrol each
 consecutive eligible patient and include 10 patients with MUS each. The GPs presented written
 information and an informed consent form to these patients. Patients had the opportunity to
 read the information to consider participation before signing the consent form.

 Randomisation: Participating patients (n=60) are equally randomised over two groups, the
 intervention group (usual care and psychosomatic therapy delivered by a psychosomatic
 therapist) and the control group (usual care of the GP). For the randomisation we used a
 random number table, whereas a central and blinded allocation procedure was applied.For the
 randomisation we used a random number table, whereas a central and blinded allocation
 procedure was applied.

 Patients in the intervention group were asked to complete a questionnaire at baseline, at the
 end of the intervention (+/- 3 months)and at 6 and 12 months. Patients in the control group
 completed a questionnaire at baseline, at 3 (equals end of intervention), 6 and 12 months.

 Statistical analysis The number of patients identified and recruited by the GP as well as the
 number of eligible patients who declined to enter the trial were analysed using descriptive
 statistics. Furthermore, at each stage of the study, we recorded the number of trial
 participants who completed the study.

 The effects of the intervention on the primary outcome measures (VAS and 4DSQ) and the
 secondary outcome measures (NHL, SF-36 and MAF) were estimated using analysis of covariance
 with baseline value as a covariate. Data analysis was be performed according to the
 intention-to-treat principle. Medical consumption was measured using the Cost Diary for
 medical consumption. Patients recorded their absenteeism and healthcare consumption, such as
 consulting a GP, hospital, paramedic facilities and alternative medicine. Medication intake
 was recorded at the start and the end of the study. We used standardised Dutch prices (guide
 cost research 2009), whereas medication costs were calculated according to the Dutch Pharmaco
 Therapeutic Compass. Costs by absenteeism were calculated according to the Friction Cost
 method.

 Difference in cost of medical consumption between the control and intervention group were
 estimated using analysis of covariance with baseline value as a covariate.

 Difference in baseline characteristics were analysed with the student's t-test for continue
 variables and the chi-squared test or Fisher's exact test for categorical variables. P-values
 of < 0.05 were considered statistical significant.
Inclusion Criteria:

 patients with medical unexplained symptoms who consulting the general practitioner more
 than once for one or more of the 12 most common symptoms:

 -  stomach-/abdominal pain,

 -  back/neck/shoulder pain,

 -  pain in arms/legs/joints,

 -  headache, chest pain,

 -  dizziness,

 -  fainting spells,

 -  palpitations of the heart,

 -  shortness of breath,

 -  nausea/indigestion,

 -  feeling tired,

 -  sleeping disorder and psychosocial distress

 Exclusion Criteria:

 -  patients wich chronic diseases,

 -  palliative care,

 -  severe psychiatric disorders,

 -  long-lasting injury treatment

 -  patients who are not able to speak, read and write Dutch