The main objective of the study is to gain insight into the cost-effectiveness of BPR compared to care as usual (CAU) for patients withSMI who have a wish for change in their societal participation. Research questions:1. Is BPR (cost-)effective…
ID
Source
Brief title
Condition
- Other condition
- Schizophrenia and other psychotic disorders
Synonym
Health condition
Doelgroep Ernstige Psychiatrische Aandoeningen (EPA), dat wil zeggen een ernstige DSM IV diagnosis, met een langere ziekteduur (> 2 jaar in zorg bij de GGZ) en beperkingen in het functioneren op meerdere levensterreinen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome for the effect study will be increase in societal
participation (getting paid work, voluntary work, and schooling (yes/no; after 6
and 12 months), measured with the Birchwood Social Functioning Scale (Birchwood
et al, 1990).
The primary outcome measures for the cost-effectiveness study are change in
social participation expressed in terms of incremental cost per proportion
increase in societal participation, and a cost-utility analysis in terms of
Quality Adjusted Life Years (QUALY).
Secondary outcome
1. Change in the number of hours of societal participation and in the position
of patients on the national societal participation
ladder (Divosa, www.participatieladder.nl).
2. Patients* experience of success (yes/no) in achieving societal participation
goals in the areas addressed, such as work and
schooling. For this purpose we developed an instrument in previous RCT*s
(Swildens et al, 2011).
3. Change in quality of life measured by the Manchester Quality of life
Schedule/MANSA (Priebe S, 1999).
4. Change in functioning is measured from different perspectives. First,
psychosocial functioning is measured by the
Birchwood Social Functioning Scale (Birchwood et al, 1990). Further change in
psychosocial functioning is measured from the MHC team*s perspective with the
Activity and Participation scale (Van Wel et al, 2002). Further change in
symptomatic functioning and psychiatric remission is measured with the
(remission items) of the Brief Psychiatric Rating Scale (Ventura et al, 1993).
5. Increase of self-esteem with the Recovery Assement Scale (Corrigan et al,
2004).
All aforementioned instruments are designed to measure change in patients with
SMI and are sensitive to measure change.
Background summary
Severe mental Illness (SMI) implies having a DSM IV diagnosis, a long duration
of the illness (> 2 years in MHC) and having disabilities in multiple life
domains. People with SMI need access to a broad array of services. These
services do not only entail provision for clinical needs (treatment and crisis
response) and humanitarian needs (e.g. physical safety, suitable housing,
acceptance as a person), but also rehabilitation needs in the areas of living
independently, social contacts, work and meaningful activities in society. It
is in these areas that BPR, developed in the US at the Boston University,
claims to have its effects.
In recent years the small number of RCT*s into BPR generated partly positive
results: increase of participation in work,
schooling, independent living, better functioning, and a better quality of
life. From 2004 to 2008 our research group performed a
well-powered RCT (n=156) in the Netherlands with support of the ZonMw programme
Geestkracht. This research involved
SMI patients with care needs in all rehabilitation areas: work, schooling,
structured activities, and social contacts, and living
independently. The rate of goal attainment was substantially higher in BPR at
12 and 24 months than with CAU. BPR was also
more effective in terms of a general measure of societal participation. Though
BPR is recommended in the Dutch guidelines for, for instance, schizophrenia,
implementation in MCH practice is limited. The lack of insight into the
cost-effectiveness structure of BPR seems to be an important obstacle.
Study objective
The main objective of the study is to gain insight into the cost-effectiveness
of BPR compared to care as usual (CAU) for patients with
SMI who have a wish for change in their societal participation.
Research questions:
1. Is BPR (cost-)effective compared to CAU after 12 months for patients with
SMI between 18 and 64 years, living independently
and receiving care by a MHC centre or an organization for supported living, who
have a wish for change in the rehabilitation
area societal participation?
2. Is BPR a (cost-) effective intervention compared to CAU after 6 months for
the aforementioned target group?
3. Is BPR an effective intervention in terms of patient satisfaction with
regard to reaching their personal rehabilitation goals,
subjective quality of life and social functioning after 6 and 12 months for our
target group?
Study design
The research will be carried out as a multicentre RCT in which 250 patients
with SMI will be included, who have a whish for change in the rehabilitation
area social participation. Treatment consists of individual sessions offered at
least once every two weeks according to BPR in de experimental group, or CAU in
the control group, during one year. Measurements with questionnaires will take
place at baseline, 6 months and 12 months. Primary analyses will be conducted
according to an 'intention to treat' protocol using multilevel and logistic
regression models. Models will be corrected for centre and other confounders.
Intervention
BPR uses a methodology that helps patients to explore, choose and realize their
rehabilitation goals in the areas of working, learning, social contacts and
living environment. The approach has three phases: a)setting a goal: helping
patients gain insight into their goals in the areas of work and study, social
contacts and living environment and into the skills and resources needed to
attain these goals; b) planning: describing necessary interventions (skills
training,support) to achieve these goals and c) carry out these interventions.
MHC workers receive training and gather practical experience with BPR under the
supervision of experts of the Dutch BPR foundation. BPR is a comprehensive
approach that can be used in different contexts such as inpatient settings,
assertive outreach teams ((F)ACT teams), and in combination with more specific
rehabilitation interventions (f.i.social skills training) and support systems.
In both conditions, patients will be offered individual sessions at least once
every two weeks to address their rehabilitation needs on the areas of societal
participation. The professionals in the control condition offer support to
patients in clarifying and realizing their goals on the basis of generic MHC
models; generic mental health nurse care, social work and generic vocational
rehabilitation programmes.
Study burden and risks
The risks of this study are evaluated as very low because participants will not
experience other risks than those normally involved in clinical psychiatric
treatment.
The intervention is offered to patients that have a express a wish for change
in societal participation (work, education, daily activities outside the home).
Patients are offered help in both conditions. Patients are informed by their
casemanagers and by the researchers that their decision to participate in the
research (yes/no) has no consequences for the careoffer in the centre. This is
also stated clearly in the information letter and informed consent form.
Burden of the intervention and questionnaires is also very low. Patients stay
in treatment as before but receive extra counseling with respect to their
rehabilitation goal minimal once every two weeks, during a year with a worker
who is trained in BPR or with a worker who will use a counselings approach that
is regularly used in the setting. Since 2012 BPR is registered in the US
Substance Abuse and Mental Health Services Administration (SAMSHA).
The questionnaires are frequently used in patients with SMI and are proven to
have a small burden. During the reserach period, patients will be measured at 3
moments. Each measurement wiill consist of an interview and questionnaires and
will take approximately one hour. Former studies with the same group showed
that this is not too much of burden on the patient.
Lange Nieuwstraat 119
Utrecht 3512 PG
NL
Lange Nieuwstraat 119
Utrecht 3512 PG
NL
Listed location countries
Age
Inclusion criteria
The inclusion criteria are:
(a) Having Severe Mental Illness (SMI); a diagnosis according to DSM IV, duration of service contact more than two years; GAF S-D score indicating substantial handicaps in global psychosocial functioning (GAF S-D: Global Assessment of Functioning - Symptoms and Dissabilities; score 60 or lower)
b) Expressing a wish for change in societal participation (work, education, daily activities outside the home).
c) Between 18-64 years of age.
d) Willing to participate in a rehabilitation process and in the research
Exclusion criteria
Excluded are patients that:
a) are legally incompetent
b) are younger than 18 years
c) are older than 64 years. We decided for the maximum age of 64 years because patients with older age usually have different goals in social participation, notably other than obtaining regular employment
d) received Boston Psychiatric Rehabilitation in the four months preceding the start of the trial
e) for all except for patients from Rintveld: are admitted as inpatient to a MHC centre,
f) for patients from Rintveld: inpatient to a MHC centre and NOT in the last phase of inpatient treatment and date of end of admission period is set.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45706.042.13 |