Table 11 Recommendations for review prior to implementation and conducting an effectiveness trial based on pilot feasibility data
Protocol aspect | Recommendations | Type of review recommended |
|---|---|---|
Trial design | • Retain Waitlist Control design • Include additional participant support check-ins for Waitlisted participants • Retain online delivery | Staffing costs review, Steering Committee review |
Recruitment | • Recruit between acute and community services and chronic samples • Enhance social media recruitment and self-referrals • Clearer advertisement of potential benefits of both BA groups • Identify methods to enhance sample representativeness | PPI consultation, clinician consultation |
Data collection | • Include further measures to characterise cognitive ABI symptoms in baseline assessment • Include 3 month or longer follow up • Remove exit interview and include additional questions in PSQ • Qualitative data collected at all follow-up time points | Staffing costs review, literature review |
Interventions | • Retain 8 sessions • Review suitability of AP group content • Adapt training manual for facilitator on ways to create therapeutic milieu online • Consider additional co-facilitator | PPI consultation, staffing costs review, Steering Committee consultation |
Outcomes | • Include measures of group cohesion • Include measures of positive and negative self-beliefs • Consider self-report executive function measures • Review choice of primary outcome measure (activity levels versus mood) | Literature review, Steering Committee consultation |