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Mental Vitality @ Work.


- candidate number9183
- NTR NumberNTR2786
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-feb-2011
- Secondary IDs10.17.1601 
- Public TitleMental Vitality @ Work.
- Scientific TitleNurses Mental Health Surveillance: Gezond functioneren van verpleegkundigen, operatie medewerkers en paramedici.
- ACRONYM
- hypothesisEmployees in the health care service are at high risk to develop common mental health complaints. These can negatively affect work functioning, with possible serious consequences for the quality of care. It is crucial to keep health care workers vital and productive. Therefore, preventive actions are necessary to promote and monitor good health and work performance.
The aim of this study is to test the effectiveness of a Workers’ Health Surveillance (WHS) mental module for nurses and allied health professionals. Two procedures for this WHS mental module will be compared to each other and a control group. As a secondary objective the cost effectiveness from a societal perspective will be studied.
- Healt Condition(s) or Problem(s) studiedMental health complaints, Impaired work functioning
- Inclusion criteria1. Working as a nurse or allied health professional;
2. Paid employee at the AMC.
- Exclusion criteriaBeing on sick-leave for 100% or less for more than 2 weeks.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-mrt-2011
- planned closingdate17-okt-2011
- Target number of participants718
- Interventions1. In the first intervention arm, participants are invited to complete an assessment to detect problems in mental health and work functioning; in case any impairments in mental health and/or work functioning are detected, a consult with an occupational physician is offered, based on care as usual following professional guidelines;
2. In the second intervention arm, participants are invited to complete an assessment to detect problems in mental health and work functioning. Subsequently, depending on their mental health state and work functioning, an individual tailored e-health intervention is offered. The five e-health interventions that can be offered are:
A. ‘Psyfit’: Aimed at well-being. It is suitable for everyone, including healthy participants;
B. ‘Sterk op je werk’: Aimed at reducing distress at work;
C. ‘Kleur je leven’: Aimed at reducing depressive symptoms;
D. ‘Geen paniek online’: Aimed at reducing panic symptoms;
E. ‘Minder drinken’: Aimed at reducing risky drinking behaviour.
The e-health interventions have been developed by the Trimbos-institute.
- Primary outcome1. The primary study parameter of the comparison between control arm and intervention arm 1 is help-seeking-behaviour. It regards adequate help sources the subject has used during the past 3 months. As adequate we understand formal help sources (e.g. general practitioner, psychologist, occupational physician);
2. The primary outcome measure of the comparison between intervention arm 2 and intervention arm 1 and the control arm respectively is work functioning, operationalized as job-specific impairments in work functioning. It will be measured using the Nurses Work Functioning Questionnaire (NWFQ). In addition, a subgroup analysis of the healthy participants comparing intervention arm 2 with 1 will be conducted.
- Secondary outcome1. The secondary study parameters of the comparison between control arm and intervention arm 1 measured at all time-points are:
A. Mental health complaints (distress, need for recovery, depression, anxiety, posttraumatic stress disorder, alcohol abuse);
B. Work functioning;
C. Intention to seek help;
D. Absenteeism.
2. The secondary study parameters of the comparison between intervention arm 1 and intervention arm 2, measured at all timepoints are:
A. Mental health complaints (distress, need for recovery, depression, anxiety, posttraumatic stress disorder, alcohol abuse);
B. Absenteeism;
C. Work engagement;
D. Well-being;
E. Workability;
F. Work productivity;
G. Turnover intention.
- TimepointsBaseline, follow-up at 3 and 6 months after baseline.
- Trial web sitehttps://www.mentalvitalityatwork.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Karen Nieuwenhuijsen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J. Sluiter
- Sponsor/Initiator Academic Medical Center (AMC), Coronel Institute of Occupational Health
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, GAK Foundation
- PublicationsN/A
- Brief summaryRationale:
Employees in the health care service are at high risk to develop common mental health complaints. These can negatively affect work functioning, with possible serious consequences for the quality of care. It is crucial to keep health care workers vital and productive. Therefore, preventive actions are necessary to promote and monitor good health and work performance.

Objective:
The aim of this study is to test the effectiveness of a Workers’ Health Surveillance (WHS) mental module for nurses and allied health professionals. Two procedures for the intervention part of this WHS mental module will be compared. As a secondary objective the cost effectiveness from a societal perspective will be studied.

Study design:
The study is a cluster randomized controlled trial design with three arms, a control arm (group 1), a detection arm plus care as usual (group 2), a detection arm plus e-health intervention (group 3). A comparison between group 1 and 2 will be referred to as Part 1, a comparison between group 2 and group 3 will be referred to as Part 2. The study will include three measurement points, a baseline measure and follow-up at three and at six months. Measurements take place by filling out online questionnaires.

Study population:
The study population consists of nurses and allied health professionals in an Academic Medical Center.

Intervention:
In the first intervention arm (group 2), participants are invited to complete an assessment to detect problems in mental health and work functioning; in case any impairments in mental health and/or work functioning are detected, a consult with an occupational physician is offered, based on care as usual following professional guidelines. In the second intervention arm (group 3), participants are invited to complete the same assessment to detect problems in mental health and work functioning. Subsequently, depending on their mental health state and work functioning, an individual tailored e-health intervention is offered.

Main study parameters:
The primary study parameter for Part 1 is help-seeking-behaviour. It regards adequate help sources which the subject has used during the past three months.
The primary outcome measure of Part 2 is impaired work functioning, operationalized as job-specific impairments in work functioning.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participants of all study arms have to fill out online questionnaires at three measurement points (30 minutes in total). In group 2, participants with common mental health complaints and/or impaired work functioning will be invited for a voluntary consult with an occupational physician. In group 3, participants will be offered to follow one or more specified self-help e-health interventions to improve their mental health status, varying in time consumption (1-3 hours per week). There are no risks associated with participating in the study.
- Main changes (audit trail)
- RECORD28-feb-2011 - 11-mrt-2011


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