Psychiatric Hospitalization
Conditions
Keywords
nutrition, aggression, n-3 fatty acids, psychiatry, inpatients admitted >2 years
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.
Interventions
DIETARY_SUPPLEMENTOrthica Soft Multi Mini and Orthica Fish EPA Mini
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 \[DHA\])
Sponsors
Atrium Innovations
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient micronutrient status | At 2 points (baseline [t0] and six months post baseline [t3]) | Blood samples (50cc) will be taken to determine micronutrient status, including Vitamins A, E, B1, B6, B12, D, and folate, total iron, magnesium, and the fatty acid spectrum. |
Countries
Netherlands
Outcome results
None listed