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Table 1 Criteria for progression from feasibility trial to full-size trial

From: The coMforT study of a trauma-informed mindfulness intervention for women who have experienced domestic violence and abuse: a protocol for an intervention refinement and individually randomized parallel feasibility trial

Progression criteriaMeasurementGreenAmberRed
RecruitmentNumber of participants recruited over 6 months2412–23< 12
RecruitmentQualitative process evaluationMost participants find the recruitment procedures acceptable or only minor amendments needed.Participants’ views on acceptability conflicting or larger changes needed.Most participants find unacceptable or changes needed unfeasible.
RandomizationQualitative process evaluationMost participants understand the randomization process and find it acceptable.Participants’ understanding and views on acceptability conflicting.Most participants do not understand process or find it unacceptable
Follow-up (total and by trial arms)Proportion of enrolled participants providing primary outcome data at 6 months post-randomization> 50%31–50%≤ 30%
Follow-up (total and by trial arms)Qualitative process evaluationMost participants find the follow up process acceptable or only minor amendments needed.Participants’ views on acceptability conflicting or larger changes needed.Most participants find processes unacceptable or changes needed unfeasible.
Uptake of TI-MBCTProportion of participants who took up the mindfulness group out of those randomized in the intervention arm [27, 28]> 70%50–69%< 50%
Retention in TI-MBCT groupProportion of participants in the intervention arm who received at least four sessions [29, 30] ≥ 60%40–59%< 40%
TI-MBCT acceptabilityQualitative process evaluationMost participants find the mindfulness group acceptable or only minor amendments needed.Views on acceptability conflicting or larger changes needed.Most participants find unacceptable or changes needed unfeasible.
Data collection methodsQualitative process evaluationMost participants find the data collection procedures acceptable or only minor amendments needed.Views on acceptability conflicting or larger changes needed.Most participants find unacceptable or changes needed unfeasible.
  1. Note: TI-MBCT trauma-informed mindfulness-based cognitive therapy