Update of statistical analysis plan for: Effect of fruit smoothie supplementation on psychological distress among people with substance use disorders receiving opioid agonist therapy: protocol for a randomised controlled trial (FruktBAR)

Abstract

This update provides a statistical analysis plan for an earlier protocol version for the randomized controlled trial, FruktBAR. This randomized control trial will evaluate the impact of daily fruit smoothie supplementation on psychological distress in people who are receiving opioid agonist therapy (OAT). The intervention group receives weekly fruit smoothie supplementation along with their standard OAT. The control group receives standard OAT. The intervention period is 16 weeks, and it was completed in October 2023. The primary outcome is the change in psychological distress measured with Hopkins Symptoms Checklist 10 at the end of the intervention and it will be analyzed according to intention-to-treat and per-protocol principles. The main analyses will be intention-to-treat. Additionally, per protocol analyses will also be conducted. Linear mixed models (coefficients with 95% CI) will be analyzed (with the randomization arm as an independent variable as well as its interaction with time). ClinicalTrials.gov NCT05229770. Registered on 08 February 2022