Table 1

Overview of participant assessment moments and outcome measurements

InstrumentPre randomisationBaseline12 weeks24 weeks
Feasibility parameters
 Interest of patients to be contacted about the studyx
 Rate of eligible trial participantsx
 Willingness of patients to consent to participate in PRINCE Primary
 Willingness of participants to complete baseline measures before randomisationx
 Participants follow-up rates to questionnaires per groupxx
Measures to identify suitable primary outcomes
 Psychosocial functioningWASASxxx
 Physical symptomsPHQ-15xxx
 Psychological distressPHQ-9xxx
 Global outcomeCGIxx
 Service useCSRI and EQ-5D-5Lxx
Potential mediators
 Treatment outcomeCBRQxxx
  • CBRQ, Cognitive Behavioural Responses Questionnaire; CGI, Clinical Global Impression; CSRI, Client Service Receipt Inventory; EQ-5D-5L, EuroQol 5 Level; PHQ 9, Patient Health Questionnaire 9; PHQ-15, Patient Health Questionnaire 15; PRINCE Primary, Persistent Physical Symptoms Reduction Intervention: a System Change and Evaluation in Primary Care; WSAS, Work and Social Adjustment Scale.