Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Dietary Supplementation
Primary Purpose
Psychiatric Hospitalization
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Orthica Soft Multi Mini and Orthica Fish EPA Mini
Sponsored by
About this trial
This is an interventional treatment trial for Psychiatric Hospitalization focused on measuring nutrition, aggression, n-3 fatty acids, psychiatry, inpatients admitted >2 years
Eligibility Criteria
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
Sites / Locations
- GGZ Centraal
- GGZ Eindhoven
- Fivoor
- GGZ Delfland
- Rivierduinen
- Parnassia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
nutritional supplement
placebo
Arm Description
2 Orthica Soft Multi Mini capsules and 1 Orthica Fish EPA Mini capsule per day; duration: 6 months
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Patient feelings of aggression
the Aangepaste Versie van de Agressievragenlijst (AVL-AV, 1), a 12 item self-report questionnaire about feelings of aggression.
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.
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).
Observed patient social dysfunction
Nursing staff will fill in the Social Dysfunction Aggression Scale (SDAS), measuring observed levels of aggression and social dysfunction.
Full Information
NCT ID
NCT02498106
First Posted
July 9, 2015
Last Updated
October 31, 2019
Sponsor
Leiden University Medical Center
Collaborators
Atrium Innovations
1. Study Identification
Unique Protocol Identification Number
NCT02498106
Brief Title
Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Dietary Supplementation
Official Title
Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Supplementation of Multivitamins, Minerals and n-3 Fatty Acids
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Atrium Innovations
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Hospitalization
Keywords
nutrition, aggression, n-3 fatty acids, psychiatry, inpatients admitted >2 years
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nutritional supplement
Arm Type
Active Comparator
Arm Description
2 Orthica Soft Multi Mini capsules and 1 Orthica Fish EPA Mini capsule per day; duration: 6 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Orthica Soft Multi Mini and Orthica Fish EPA Mini
Intervention Description
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])
Primary Outcome Measure Information:
Title
Number of aggressive incidents
Description
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 Outcome Measure Information:
Title
Patient feelings of aggression
Description
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])
Title
Patient quality of life
Description
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])
Title
Patient psychiatric symptoms
Description
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])
Title
Observed patient social dysfunction
Description
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])
Other Pre-specified Outcome Measures:
Title
Patient micronutrient status
Description
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.
Time Frame
At 2 points (baseline [t0] and six months post baseline [t3])
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik J. Giltay, MD PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
GGZ Centraal
City
Ermelo
State/Province
Gelderland
ZIP/Postal Code
3853 LC
Country
Netherlands
Facility Name
GGZ Eindhoven
City
Eindhoven
State/Province
Noord-Braband
ZIP/Postal Code
5626 ND
Country
Netherlands
Facility Name
Fivoor
City
Den Dolder
State/Province
Utrecht
ZIP/Postal Code
3734 AC
Country
Netherlands
Facility Name
GGZ Delfland
City
Delft
State/Province
Zuid-Holland
Country
Netherlands
Facility Name
Rivierduinen
City
Oegstgeest
ZIP/Postal Code
2342 EB
Country
Netherlands
Facility Name
Parnassia
City
The Hague
ZIP/Postal Code
2512 HN
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
18852480
Citation
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Results Reference
background
PubMed Identifier
12072137
Citation
Nijman H, Palmstierna T. Measuring aggression with the staff observation aggression scale--revised. Acta Psychiatr Scand Suppl. 2002;(412):101-2. doi: 10.1034/j.1600-0447.106.s412.21.x.
Results Reference
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PubMed Identifier
400996
Citation
Asberg M, Schalling D. Construction of a new psychiatric rating instrument, the Comprehensive Psychopathological Rating Scale (CPRS). Prog Neuropsychopharmacol. 1979;3(4):405-12. doi: 10.1016/0364-7722(79)90055-9.
Results Reference
background
PubMed Identifier
15085902
Citation
Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
Results Reference
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PubMed Identifier
10706231
Citation
Schoenthaler SJ, Bier ID. The effect of vitamin-mineral supplementation on juvenile delinquency among American schoolchildren: a randomized, double-blind placebo-controlled trial. J Altern Complement Med. 2000 Feb;6(1):7-17. doi: 10.1089/acm.2000.6.7.
Results Reference
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PubMed Identifier
12091259
Citation
Gesch CB, Hammond SM, Hampson SE, Eves A, Crowder MJ. Influence of supplementary vitamins, minerals and essential fatty acids on the antisocial behaviour of young adult prisoners. Randomised, placebo-controlled trial. Br J Psychiatry. 2002 Jul;181:22-8. doi: 10.1192/bjp.181.1.22.
Results Reference
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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Results Reference
derived
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Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Dietary Supplementation
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