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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)