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Table 2 Screening and data collection across the trial

From: Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) – a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial

 

Completed by

Baseline

End of Therapy

9 weeks

20 weeks

40 weeks

52 weeks

ASSESSMENTS

 Primary Outcomes

  WSAS

P

X

 

X

X

X

X

 Secondary Outcomes

  PHQ-15

P

X

 

X

X

X

X

  PHQ-9

P

X

 

X

X

X

X

  GAD-7

P

X

 

X

X

X

X

  PPS Questionnaire

P

X

 

X

X

X

X

  CGI-patient

P

X

 

X

X

X

X

  CSRI

P

X

 

X

X

X

X

  EQ-5D-5 L

P

X

 

X

X

X

X

 Process Variables

  Therapy Process Indicators

   Treatment Attendance and Homework Logb

T

      

   Treatment Adherenceb

T

      

   Treatment Fidelity

IC

 

X

    

   Competence Rating

IC

 

X

    

  Satisfaction with Treatmenta

P

   

X

X

X

  CGI-therapist

T

 

X

    

  PSYCHLOPSa

P

X

 

X

X

X

X

  Mechanisms of Change

   CBRQ

P

X

 

X

X

X

X

   Acceptance Scale

P

X

 

X

X

X

X

 Baseline

  Demographic Variables

P

X

     

  Clinical Information

P

X

     

  Preferred Treatment Group

P

X

     

  Therapist Background Measures

T

X

     

 Other

  Concomitant Medications

P

X

 

X

X

X

X

  Serious/Adverse Events

P

   

X

X

X

  1. WSAS work and social adjustment scale, PPS Questionnaire persistent physical symptoms questionnaire, PHQ-9 patient health questionnaire – 9 item scale, GAD-7 generalised anxiety disorder – 7 item scale, PHQ-15 patient health questionnaire – 15 item scale, CGI clinical global impression scale, CBRQ cognitive behavioural responses questionnaire, CSRI client service receipt inventory, EQ-5D-5 L EuroQol 5 Dimension 5 Level, PSYCHLOPS psychological outcome profiles, P patient, IC independent clinician, T therapist. a Assessment only completed by participants assigned to the intervention group. b completed after each therapy session