|- candidate number||1487|
|- NTR Number||NTR289|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Effectiveness of the Psychiatric Rehabilitation approach in the Netherlands.|
|- Scientific Title||RCT on the short term and long term effectiveness of the Psychiatric Rehabilitation (PR) approach (developed by Anthony & Farkas, 1989) for persons with severe mental illness. |
|- hypothesis||The central research question is: what is the effectiveness of PR in attaining patients personal rehabilitation goals, in improving patients functioning, empowerment and quality of life compared to 'rehabilitation as usual'?
PR is a systematic rehabilitation process consisting of three phases:
1 diagnosis: helping patients gain insight into their future goals in the rehabilitation areas (housing, work/daily activities, learning and social contacts), and insight into which skills and resources are needed to attain these goals.
2 planning: describing the interventions necessary to attain the clients' rehabilitation goals.
3 intervention: conducting resource development and/or skill development.
|- Healt Condition(s) or Problem(s) studied||Mental illness|
|- Inclusion criteria||1. Patients are adults with severe mental illness who receive MHC in clinical settings or in out-patients settings;|
2. Patients must have a wish for change in at least one of the main rehabilitation areas (housing, work/daily activities, learning and social contacts);
3. Patients must have new goals: he/she is not already trying to obtain the goals mentioned with a rehabilitation worker;
4. Patients must accept the rehabilitation offer and participate in the research;
5. Patients should be willing to give informed consent.
|- Exclusion criteria||There are no other exclusion criteria; |
patients with severe mental illness with different ages, and different psychiatric diagnosis can participate.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2003|
|- planned closingdate||1-jan-2007|
|- Target number of participants||157|
|- Interventions||The study is designed as an RCT in four mental health organisations, comparing:|
-PR by fully trained rehabilitation workers (EXP) and
-‘Rehabilitation as usual’ by case managers/ psychiatric–MHC nurses with no PR training (CC).
A total of 160 patients were planned to be included in the RCT: 80 EXP and 80 CC.
Fidelity criteria for the performance of PR in the experimental condition were developed at the start of the study.
The patients can receive either the PR intervention or ‘rehabilitation as usual’ during the whole research period of two years following randomisation.
In both conditions there is a minimum of at least once per three weeks an individual contact between the patient and the rehabilitation worker.
|- Primary outcome||The primary outcome criterion is goal attainment. Patients are interviewed three times, at the start (T0) after one year (T1) and after two years (T2). At the same time rehabilitation workers and psychiatrists are asked to fill out questionnaires.|
|- Secondary outcome||Other outcome criteria are (changes in) functioning, empowerment, quality of life and (met and unmet) needs for care.
|- Trial web site||http://www.kenniscentrumrehabilitatie.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||PhD. W. Swildens|
|- CONTACT for SCIENTIFIC QUERIES||PhD. W. Swildens|
|- Sponsor/Initiator ||Altrecht Institute for Mental Health Care, University Medical Center Groningen (UMCG), Rob Giel Research Center (RGOc), Trimbos-institute - Netherlands Institute of Mental Health and Addiction, Bavo RNO Group Rotterdam , Eindhoven Mental Health Care , Groningen Mental Health Care |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Altrecht Mental Health Care , Bavo RNO Group, Eindhoven Mental Health Care, Groningen Mental Health Care |
|- Brief summary||This research is a RCT on the short term (1 year) and long term (2 years) effectiveness of PR for persons with severe mental illnes. The PR approach, developed by Anthony & Farkas in the 1980's, was wide spread in Dutch MHC since 1992. |
In the past years some naturalistic studies were done (Van Busschbach et al, 2002; Swildens et al, 2003) but no research on the effectiveness of the approach was available. In 2003 a research group was formed to set of the first Dutch RCT on PR.
The research is conducted in four MHC centres in The Netherlands. 157 Patients were included (80 EXP).The effectiveness of PR by fully trained rehabilitation workers is compared to 'rehabilitation as usual' by case managers/psychiatric-MHC nurses with no PR training.
The outcome measures are deduced from the central mission of the PR approach: "to help persons with long term psychiatric dissabilities increase their functioning so that they are succesfull and satisfied in the environments of their choice, with the least amount of ongoing professional intervention (Farkas & Anthony, 1989)".
It concerns a pragmatic experiment; generalization to regular MHC practices is a central object.
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 19-okt-2009|