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Table 1 Feasibility and acceptability outcomes

From: Cognitive-behavioural therapy for the management of inflammatory bowel disease-fatigue: a feasibility randomised controlled trial

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

  1. IBD inflammatory bowel disease, HCPs healthcare professionals