Diet and Aggression: Reducing aggression among chronic psychiatric inpatients through supplementation of multivitamins, minerals and n-3 fatty acids

Diet and Aggression: Reducing aggression among chronic psychiatric inpatients through supplementation of multivitamins, minerals and n-3 fatty acids - Diet and Aggression

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47917

Enrollment

200

Registered

2015-04-17

Start date

2015-04-29

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aggressive behaviour among long-term psychiatric inpatients

Interventions

During six months, one group will receive three capsules daily: 1 Orthica Fish EPA Mini en 2 Orthica Multi Energie, the other group will receive three placebo capsules daily.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: residing at a facility for long-term psychiatric inpatient care age 18 or over

Exclusion criteria

Exclusion criteria: Pregnancy Breastfeeding Known contra-indication for using the supplements used in this study (as specified in the Summary of Product Characteristics; SPC) Expected discharge or transfer to a not included institution within the next eight weeks Current use or use in the past eight weeks of nutritional supplements and refusal to quit this use for the duration of the study, with the exception of vitamin B1 (thiamine) and vitamin D Contra-indication for the use of pork-gelatin Failure to complete the two-week run-in phase

Design outcomes

Primary

Measure	Time frame
The main parameter in this study is the number of aggression incidents in each arm as registered with the Staff Observation Aggression Scale-revised (SOAS-R, Nijman et al., 1999). As incidents differ in severity and consequences, they will be divided in major and minor incidents, major incidents are: severe threats, fighting, assault on patients or staff, self-harm, suicide attempt ; minor incidents are: verbal aggression, threats, non-compliance with hospital rules, aggression towards objects, disinhibited [sexual] behaviour. In our pilot study in institutions for long-term psychiatric inpatient care (Hazewinkel et al., in preparation) we monitored the time spent by nursing staff on each of these four types of incidents; verbal aggression took 80 minutes, aggression towards objects cost 77 minutes, self-harm cost 222 minutes, and physical aggression towards others cost 335 minutes per incidents. Based on these results, major incidents will be weighted by a factor 3.8.	—

Measure

Time frame

The main parameter in this study is the number of aggression incidents in each arm as registered with the Staff Observation Aggression Scale-revised (SOAS-R, Nijman et al., 1999). As incidents differ in severity and consequences, they will be divided in major and minor incidents, major incidents are: severe threats, fighting, assault on patients or staff, self-harm, suicide attempt ; minor incidents are: verbal aggression, threats, non-compliance with hospital rules, aggression towards objects, disinhibited [sexual] behaviour. In our pilot study in institutions for long-term psychiatric inpatient care (Hazewinkel et al., in preparation) we monitored the time spent by nursing staff on each of these four types of incidents; verbal aggression took 80 minutes, aggression towards objects cost 77 minutes, self-harm cost 222 minutes, and physical aggression towards others cost 335 minutes per incidents. Based on these results, major incidents will be weighted by a factor 3.8.

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Secondary

Measure	Time frame
Secondary parameters are: * facilitators and barriers of nutritional supplement acceptation by long-stay psychiatric inpatients (see J) * costs of time spent by staff members on aggression incidents and additional costs of incidents * patient quality of life as measured with the WHOQL-bref * patient self-report aggression levels as measured with the AVL-AV * patient observer rated affective symptoms as measured with the vCPRS * patient observer rated aggression levels as measured with the SDAS	—

Measure

Time frame

Secondary parameters are: * facilitators and barriers of nutritional supplement acceptation by long-stay psychiatric inpatients (see J) * costs of time spent by staff members on aggression incidents and additional costs of incidents * patient quality of life as measured with the WHOQL-bref * patient self-report aggression levels as measured with the AVL-AV * patient observer rated affective symptoms as measured with the vCPRS * patient observer rated aggression levels as measured with the SDAS

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)