Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour

Nienke J de Bles, David A A Gast, Abe J C van der Slot, Robert Didden, Albert M van Hemert, Nathaly Rius-Ottenheim, Erik J Giltay, Nienke J de Bles, David A A Gast, Abe J C van der Slot, Robert Didden, Albert M van Hemert, Nathaly Rius-Ottenheim, Erik J Giltay

Abstract

Background: Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs.

Approach: In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. We describe five main difficulties and how these were overcome: (1) multisite setting, (2) inclusion of vulnerable participants, (3) nutritional supplements and placebos, (4) assessment of behavioural outcomes, and (5) collecting bio samples.

Conclusions: By sharing these practical experiences, we hope to inform other researchers how to optimally design their trials, while avoiding and minimising the difficulties that we encountered, and to facilitate the implementation of a trial. Both trials were registered in the Clinical Trials Register (RCT A: NCT02498106; RCT B: NCT03212092).

Keywords: aggression; lessons learned; multisite; nutritional supplements; trial.

Conflict of interest statement

The authors declare that there are no conflict of interests.

© 2022 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons Ltd.

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