Progressing the evaluation of managing emotions groups in severe mental illness: feasibility of methodology for an effectiveness randomised controlled trial of scaled up delivery.

OBJECTIVES

Transdiagnostic group interventions targeting emotion regulation (ER) are commonly offered to individuals with severe mental illness (SMI). Previous feasibility studies have provided insufficient information to support progression to effectiveness evaluation of scaled-up delivery. We aimed to address this gap.

METHODS

We conducted a feasibility randomised controlled trial of a protocolised group ER intervention for individuals with SMI, delivered online and facilitated by a trained junior workforce. Feasibility markers were recruitment, retention, data completeness, intervention uptake and completion (≥50% sessions), adherence to the intervention protocol, and participant satisfaction. Participants were recruited from community mental health services and randomly allocated (1:1) to intervention or waitlist control groups.

RESULTS

Feasibility was demonstrated, with 6/7 markers categorised 'green' and 1/7 'amber' against predetermined progression criteria. Recruitment targets were met (n = 34 service users; n = 9 junior facilitators), retention was 85.3%, and paired outcome completion was 82.4%. Staff self-reported high adherence and participant satisfaction was 89.6%. Intervention completion was 61.1% (green target=>80%; amber target=>60%), suggesting scope to improve engagement.

LIMITATIONS: Participants dropping out of the intervention were lost to follow-up, limiting assessment of reasons for non-continuation. Implications of unblinded researchers at post-assessment are discussed. Group-level and contextual treatment data were not routinely collected due to naturalistic intervention delivery.

CONCLUSIONS

An effectiveness trial of a protocolised group ER intervention for SMI, delivered online by junior staff, is feasible. A larger multi-site pilot trial to estimate sample size for a confirmatory trial, incorporating methodological refinements to increase intervention completion, is the next step.