Statistical and health economic analysis plan for a secure care hospital evaluation of manualised (interpersonal) art-psychotherapy: the SCHEMA randomized controlled trial.

ABSTRACT:

Background

The SCHEMA trial evaluates whether interpersonal art psychotherapy reduces the frequency/severity of aggressive incidents or patient distress associated with psychiatric symptoms, compared to usual care.

Objective

To describe the statistical and health economic analysis plan.

Methods

A multicentre, two-arm, parallel-group, single blind individually randomised controlled trial with 150 adults within NHS secure care who have borderline to mild/moderate intellectual disability. The primary outcome is the frequency/severity of aggressive behaviour, measured on the Modified Overt Aggression Scale (MOAS) 19 weeks post-randomisation, analysed using a linear mixed-effect model, adjusted for baseline MOAS and stratification by gender and psychosis diagnosis. Changes

SUBMITTER: Condie J 

PROVIDER: S-EPMC12210588 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature