Abstract

Aggression and violent incidents are a major concern in psychiatric in-patient care. Nutritional supplementation has been found to reduce aggressive incidents and rule violations in forensic populations and children with behavioural problems. To assess whether multivitamin, mineral and n-3 polyunsaturated fatty acid supplementation would reduce the number of aggressive incidents among long-stay psychiatric in-patients. The trial was a pragmatic, multicentre, randomised, double-blind placebo-controlled study. Data were collected from 25 July 2016 to 29 October 2019, at eight local sites for mental healthcare in The Netherlands and Belgium. Participants were randomised (1:1) to receive 6-month treatment with either three supplements containing multivitamins, minerals and n-3 polyunsaturated fatty acid, or placebo. The primary outcome was the number of aggressive incidents, determined by the Staff Observation Aggression Scale - Revised (SOAS-R). Secondary outcomes were patient quality of life, affective symptoms and adverse events. In total, 176 participants were randomised (supplements, n = 87; placebo, n = 89). Participants were on average 49.3 years old (s.d. 14.5) and 64.2% were male. Most patients had a psychotic disorder (60.8%). The primary outcome of SOAS-R incidents was similar in supplement (1.03 incidents per month, 95% CI 0.74-1.37) and placebo groups (0.90 incidents per month, 95% CI 0.65-1.19), with a rate ratio of 1.08 (95% CI 0.67-1.74, P = 0.75). Differential effects were not found in sensitivity analyses on the SOAS-R or on secondary outcomes. Six months of nutritional supplementation did not reduce aggressive incidents among long-stay psychiatric in-patients.

Highlights

  • Aggression and violent incidents are a major concern in psychiatric in-patient care

  • The primary outcome was the number of aggressive incidents, determined by the Staff Observation Aggression Scale – Revised (SOAS-R)

  • The primary outcome of SOAS-R incidents was similar in supplement (1.03 incidents per month, 95% CI 0.74–1.37) and placebo groups (0.90 incidents per month, 95% CI 0.65–1.19), with a rate ratio of 1.08

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Summary

Methods

The trial was a pragmatic, multicentre, randomised, double-blind placebo-controlled study. Data were collected from 25 July 2016 to 29 October 2019, at eight local sites for mental healthcare in The Netherlands and Belgium. Secondary outcomes were patient quality of life, affective symptoms and adverse events. This pragmatic, multicentre, randomised, double-blind, placebocontrolled intervention trial was coordinated in the Department of Psychiatry at the Leiden University Medical Centre (LUMC). Participants were recruited between 25 July 2016 and 29 October 2019, from eight local sites for mental healthcare in The Netherlands and Belgium. The trial protocol (Supplementary Appendix 3) was approved by the Medical Ethical Committee of the LUMC, under reference number P14.332, and the study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

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