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Table 4 Project structure

From: Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

  Intervention Group Control Group
Recruitment visit (V 0) Selection criteria
Consecutive selection Request on informed consent
  PRIME MD Questionnaire
  Variables:
  · SF-12 Questionnaire on life quality
  · Descriptive variables: sex, cultural level, age, months with symptoms, time on antidepressants consumption, requested tests y specialized derivations to
Training of professionals involved Training in management of PRIME-MD survey. Review of Standards of Good Clinical Practice
  Training in cognitive-behavioral (Only intervention Group)  
Baseline visit (V1) Variables:
  · SF-12 Questionnaire
  · Prescribed medicine
  · Requested tests
  · Derivations to secondary level
  · Days of sickness absence
  · Assessment of compliance with the standards of good clinical practice
  · Questionnaire on global clinical impression; both, the doctor and the patient
Intervention There will be a weekly group session for 4 weeks (Only intervention Group)  
  Routine clinical practice
3-months post Intervention visit (V2) Variables:
  · SF-12 Questionnaire
  · Prescribed medicine
  · Requested tests
  · Derivations to secondary level
  · Days of sickness absence
  · Assessment of compliance with the standards of good clinical practice
  · Questionnaire on global clinical impression; both, the doctor and the patient
  · Assessment by the nurse subject participation.  
  · Assessment of cognitive- behavioral module by subject (Only intervention Group)  
6-months post Intervention visit (V3) 12-months post Intervention visit (V4) Variables:
· SF-12 Questionnaire
· Prescribed medicine
· Requested tests
· Derivations to secondary level
· Days of sickness absence
· Assessment of compliance with the standards of good clinical practice
· Questionnaire on global clinical impression; both, the doctor and the patient
  · Assessment of cognitive- behavioral module by subject (Only intervention Group)