|- candidate number||23596|
|- NTR Number||NTR5585|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jan-2016|
|- Secondary IDs||NWO 432-12-808 CCMO NL53845.028.15|
|- Public Title||Societal participation and overcoming adversity|
|- Scientific Title||Managing victimization risks attached to societal participation by people with severe mental illness|
|- hypothesis||The Victoria modules are thought to have a positive effect on acknowlegdement for adversities and risk awareness. This can be used to take acceptable risks in rehabilitation process. This will then lead to more societal participation and less victimization and other forms of adversity.|
|- Healt Condition(s) or Problem(s) studied||Victimization, Severe mental illness, Social functioning|
|- Inclusion criteria||- having a Severe Mental Illness|
- receiving care from a Flexible Assertive Community Treatment team of the Mental Health Care Centres Dijk en Duin or Eindhoven
- Older than 17 years of age
- Willing to participate in the research
|- Exclusion criteria||- younger than 18 years of age|
- insufficient command of the Dutch language
- incapable to answer questions due to cognitive impairments, severe symptomatology, or psychoorganic disorders
- prolonged admission to psychiatric hospital, or staying in prison
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2016|
|- planned closingdate|
|- Target number of participants||470|
|- Interventions||Victoria is a methodology to explore victimization (risks) attached to societal participation with severe mental illness, in the form of a conversation module. |
The experimental teams receive the Victoria modules, and the control groups receive care as usual.
|- Primary outcome||The primary study parameters will be safety and societal participation.|
|- Secondary outcome||The secondary study parameters will be self-confidence and quality of life.|
|- Timepoints||T0 = no intervention, starts Feb. 2016.|
training in Victoria.
T1 = experiment and control group, 9 months after T0.
T2 = experiment and control group, 9 months after T1.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Jaap van Weeghel|
|- CONTACT for SCIENTIFIC QUERIES|| Wendy Albers|
|- Sponsor/Initiator ||Tilburg University, GGZ Eindhoven (GGzE), Stichting Rehabilitatie '92, Dijk & Duin|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background
People with severe mental illness (SMI) in the Netherlands are more often victims than perpetrators of violence, and are also more often victimized than other Dutch citizens. This victimization appears to be one of the risks that these service users of mental health care have to deal with in their efforts to participate in the community. Other risks in societal participation are rejection, failure, loss and social stigma with possible adverse consequences.
Objective of the study
The main objective of the study is to gain insight in the effectiveness of the Victoria modules, in terms of acknowledgement for these experiences and risk awareness. These experiences and insights can be used to take acceptable risks in rehabilitation process. The focus is on increasing societal participation, reducing victimization and other forms of adversity.
The first part of the module aims at exploring victimization experiences or other forms of adversity that service users have experienced in societal participation. The second part focuses on the evaluation of rehabilitation crises, with specific attention to the social context in which the crisis has occurred and environmental triggers that brought the service user off balance.
Study design and methods
The research will be carried out as a multicentre RCT, in which 470 outpatients will be included. Randomization is at a team level. A total of 8 FACT-teams of 2 institutes for mental health care are included. There are three moments of measurement: at the start (T0), after 9 months (T1), and after 18 months of intervention (T2).
Generalized linear mixed modelling is used to examine whether there is an effect on primary and secondary outcome parameters (societal participation, victimization, self-confidence, stigmatization and discrimination, and quality of life).
|- Main changes (audit trail)|
|- RECORD||11-jan-2016 - 14-feb-2016|