Primary endpoints | Secondary endpoints |
---|---|
Number of patients screened for eligibility | Intervention adherence for patients in the intervention arm (number of sessions attended, number of participants in group sessions, whether homework was completed, reasons for non-attendance/non-compliance) |
Number and proportion of patients eligible out of those screened and reasons for ineligibility | Website use (tracking data to include number of visits, pages visited, materials downloaded, videos watched, clicked links) |
Number and proportion of patients consenting to randomisation out of those eligible and reasons for non-randomisation | Number of patients deemed as having completed the intervention |
Number of participants randomised per site per month | Treatment as usual content in both arms from participants (number of sessions attended and content of sessions) and sites (initiatives implemented during the trial) |
Questionnaire completion rates at each time-point | Safety (deaths, hospitalisations related to the intervention, RUSAEs) |
Number of items of missing data per questionnaire at each time-point | Acceptability of the ACTION intervention to participants (acceptability and B&N questionnaires) |
Number and proportion of randomised participants lost-to-follow-up | Number, proportion and timing of therapist withdrawals and reasons for withdrawal |
Number, proportion, type and timing of participant withdrawals out of those randomised and reasons for withdrawal | Qualitative study |
Competency and fidelity of the delivery of the ACT intervention by NHS therapists (ACTKQ, ACT-FM, Procedural fidelity checklist) | |
“Proof-of-principle” exploration in outcome and process variables | |
Estimation of the intracluster correlation coefficient |