Psychosomatic Therapy, Feasibility and Cost Analysis
Condition: Medically Unexplained Symptoms; Psychosomatic Therapy
MeSH terms: Medically Unexplained Symptoms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Psychosomatic therapy; care as usual
Intervention type(s): Other; Other
Intervention description(s): Psychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education delivery, 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.; usual care of the general practitioner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medically unexplained symptoms; Somatization; Psychosomatic therapy