Table 1.
Overview of participant assessment moments and outcome measurements
| Instrument | Pre randomisation | Baseline | 12 weeks | 24 weeks | |
| Feasibility parameters | |||||
| Interest of patients to be contacted about the study | x | ||||
| Rate of eligible trial participants | x | ||||
| Willingness of patients to consent to participate in PRINCE Primary | |||||
| Willingness of participants to complete baseline measures before randomisation | x | ||||
| Participants follow-up rates to questionnaires per group | x | x | |||
| Measures to identify suitable primary outcomes | |||||
| Psychosocial functioning | WASAS | x | x | x | |
| Physical symptoms | PHQ-15 | x | x | x | |
| Psychological distress | PHQ-9 | x | x | x | |
| Global outcome | CGI | x | x | ||
| Service use | CSRI and EQ-5D-5L | x | x | ||
| Potential mediators | |||||
| Treatment outcome | CBRQ | x | x | x | |
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.