Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Dietary Supplementation

Not Applicable

Completed

• Conditions: Psychiatric Hospitalization
• Interventions: Dietary Supplement: Orthica Soft Multi Mini and Orthica Fish EPA Mini

• Registration Number: NCT02498106
• Lead Sponsor: Leiden University Medical Center

Brief Summary

The overall goal of this study is to investigate whether the daily administration of multivitamins, minerals and n-3 fatty acids will reduce aggression in long-term psychiatric inpatients and will thereby reduce costs of care.

Detailed Description

Aggressive incidents are highly prevalent among chronic psychiatric inpatients. Previous studies have demonstrated the potential of multivitamin-, mineral-, and n-3 fatty acids (n-3FA) supplementation to reduce aggression in adolescent and forensic populations. To test the hypothesis that multivitamin-, mineral-, and n-3FA supplementation reduces aggression among chronic psychiatric inpatients, we designed a pragmatic, randomised, double-blind, placebo controlled, multicentre intervention study among psychiatric inpatients residing in long-stay psychiatric wards. During 6 months, one group receives 2 supplements daily from Orthica: one containing vitamins and minerals (vitamins \[B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene; Calcium, Iodine, Copper, Magnesium, Selenium, Iron, Zinc, Potassium, Chrome, Manganese\]) and one containing fish fatty acids (n-3FA: eicosapentaenic acid \[EPA\] and docosahexaenic acid \[DHA\]) and the other group receives 2 placebo capsules.

The main study parameter is the number of aggressive incidents from baseline (t0) to endpoint (six months post baseline, t3). Patients who wish to participate enter a 2-week run-in phase in which they take 2 placebo capsules daily. After positive evaluation of this run-in phase patients are randomized to the active or the control condition. Participants will then start the daily use of 2 supplement capsules or 2 placebo capsules, which will continue for 6 months. At 3 time points (at baseline \[t0\] and at 2 and 6 months post-baseline \[t2 and t3\]), three questionnaires measuring feelings of aggression, quality of life, and psychiatric symptoms will be administered. Also, at t0 and t3 (micro)nutrient status will be determined. Finally, at 4 time points (t0, 2 weeks post baseline \[t1\], t2 and t3), nursing staff will report on observed levels of aggression and social dysfunction.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-15
• Status Verified: 2019-10
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• residing at a facility for long-term psychiatric inpatient care
• age 18 or over

Exclusion Criteria

• pregnancy
• breastfeeding
• known contra-indication for using the supplements used in this study
• expected discharge or transfer within the next 8 weeks
• current use of dietary supplements and refusal to stop using these for the duration of the study
• failure to complete run-in phase
• contra-indication for the use of pork-gelatin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Orthica Soft Multi Mini and Orthica Fish EPA Mini	During 6 months one group receives 3 placebo supplements daily with identical look and feel to Orthica Soft Multi Mini and Orthica Fish EPA Mini
nutritional supplement	Orthica Soft Multi Mini and Orthica Fish EPA Mini	2 Orthica Soft Multi Mini capsules and 1 Orthica Fish EPA Mini capsule per day; duration: 6 months

Primary Outcome Measures

Name	Time	Method
Number of aggressive incidents	daily for the total duration of the (six-month) intervention period	The main study parameter is the number of aggressive incidents from baseline (t0) to endpoint (six months post baseline, t3), as registered daily on the ward by nurses using the Dutch version of the Staff Observation Aggression Scale- Revised version (SOAS-R)

Secondary Outcome Measures

Name	Time	Method
Patient quality of life	At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])	the World Health Organization Quality of Life Questionnaire (WHO-QL-bref 5), a 26-item observer rated quality of life instrument.
Patient feelings of aggression	At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])	the Aangepaste Versie van de Agressievragenlijst (AVL-AV, 1), a 12 item self-report questionnaire about feelings of aggression.
Patient psychiatric symptoms	At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])	The verkorte Comprehensive Psychopathological Rating Scale (vCPRS), a 25-item observer rated instrument on affective symptoms, which includes the Montgomery-Åsberg Depression Rating Scale (MADRS).
Observed patient social dysfunction	At 4 points (baseline [t0], 2 weeks post baseline [t1], 2 months post baseline[t2] and six months post baseline [t3])	Nursing staff will fill in the Social Dysfunction Aggression Scale (SDAS), measuring observed levels of aggression and social dysfunction.

Trial Locations

Locations (6)

GGZ Eindhoven; 🇳🇱 Eindhoven, Noord-Braband, Netherlands

GGZ Delfland; 🇳🇱 Delft, Zuid-Holland, Netherlands

Parnassia; 🇳🇱 The Hague, Netherlands

Rivierduinen; 🇳🇱 Oegstgeest, Netherlands

Fivoor; 🇳🇱 Den Dolder, Utrecht, Netherlands

GGZ Centraal; 🇳🇱 Ermelo, Gelderland, Netherlands