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

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. Approa...

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Bibliographic Details
Published in:Journal of evaluation in clinical practice 2022-08, Vol.28 (4), p.607-614
Main Authors: Bles, Nienke J., Gast, David A. A., Slot, Abe J. C., Didden, Robert, Hemert, Albert M., Rius‐Ottenheim, Nathaly, Giltay, Erik J.
Format: Article
Language:English
Subjects:
aggression
Aggressiveness
Clinical trials
Dietary supplements
Intellectual disabilities
lessons learned
Medical research
Mental disorders
Mental health care
multisite
nutritional supplements
trial
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Summary: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).
ISSN:1356-1294
1365-2753
DOI:10.1111/jep.13653