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

Leiden University Medical Center176 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

176

Conditions

Psychiatric Hospitalization

Interventions

Orthica Soft Multi Mini and Orthica Fish EPA MiniDIETARY_SUPPLEMENT

daily intake of 2 Orthica Soft Multi Mini capsules (containing vitamins \[B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene\] and minerals \[Iodine, Copper, Selenium, Iron, Zinc, Chrome, Manganese\]) and 1 Orthica Fish EPA Mini capsule (containing n-3FA: eicosapentaenic acid \[EPA\] and docosahexaenic acid \[DHA\])

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

GGZ Centraal

Ermelo, Gelderland, Netherlands

GGZ Eindhoven

Eindhoven, Noord-Braband, Netherlands

GGZ Delfland

Delft, South Holland, Netherlands

Fivoor

Den Dolder, Utrecht, Netherlands

Outcomes

Primary Outcomes

Number of aggressive incidents

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)

Time frame: daily for the total duration of the (six-month) intervention period

Secondary Outcomes

Patient feelings of aggression

the Aangepaste Versie van de Agressievragenlijst (AVL-AV, 1), a 12 item self-report questionnaire about feelings of aggression.

Time frame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])

Patient quality of life

the World Health Organization Quality of Life Questionnaire (WHO-QL-bref 5), a 26-item observer rated quality of life instrument.

Time frame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])

Patient psychiatric symptoms

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).

Time frame: At 3 points (baseline [t0], 2 months post baseline [t2] and six months post baseline[ t3])

Observed patient social dysfunction

Nursing staff will fill in the Social Dysfunction Aggression Scale (SDAS), measuring observed levels of aggression and social dysfunction.

Time frame: At 4 points (baseline [t0], 2 weeks post baseline [t1], 2 months post baseline[t2] and six months post baseline [t3])

Data from ClinicalTrials.gov

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