Outcome | Objectives | Methods | Progression criteria |
---|---|---|---|
Recruitment | Assess the feasibility of recruiting eligible participants; assess the willingness of participants to be randomised | Recruitment log; screening log; record of reasons for participation refusal | ≥ 50% of eligible participants will consent for participation in the study |
Completeness of outcome data measures | Assess the completeness of the outcome data questionnaire booklets | Outcome data questionnaire booklets | ≤10% missing data in each completed questionnaire booklet |
Compliance | Evaluate the compliance rates of participants to the intervention | Post-intervention follow-up questionnaire with participants; semi-structured interviews with therapists | 90% of participants will read all the sessions of the manual; ≥ 15 min per week will be spent completing tasks in relation to the intervention |
Retention | Assess withdrawal rates during the intervention support sessions; assess the completion rates of the outcome measures at follow-up | Recruitment log therapist session log of participants’ compliance; semi-structured interviews with participants | ≥ 80% of those consented will start the intervention; ≥ 70% of participants who start will complete all 8 therapist support sessions; ≤ 20% of participants will withdraw from the intervention support sessions; ≥ 70% of participants will complete baseline and 3-month follow-ups |
Delivery | Evaluate therapists’ views on the intervention delivery | Semi-structured interviews with therapists | There will be positive opinions from the therapists regarding the feasibility of delivering the intervention |
Implementation | Evaluate HCPs views on the intervention implementation | Semi-structured interviews with HCPs working with people with IBD | There will be support from HCPs regarding the feasibility of implementation of the intervention |
Acceptability of the intervention | Evaluate participants’ experience of the intervention | Semi-structured interviews with a sub-set participants in Group 1; post-intervention follow-up questionnaire | There will be positive opinions from participants regarding an acceptably positive experience of taking part in the intervention |