Schizophrenia Clinical Trial
Official title:
Large-scale Implementation of Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe
A single-blinded hybrid effectiveness-implementation trial (Type II), that both evaluates the intervention outcomes (clinical and service use outcomes) through patient-randomization in the implementation sites, as well as evaluates the implementation strategy chosen for the intervention and its impact on implementation outcomes (e.g. adoption, fidelity, acceptability and maintenance (continued implementation) of the intervention).
The overall goal of the study is to contribute to improving the level of functioning and
quality of life and mental health outcomes for people with severe and enduring mental ill
health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and upscaling the
implementation of a community-based service delivery model in Montenegro.
Effectiveness component of the trial: Multidisciplinary community mental health teams for
people with SMI.
The intervention condition offers flexible, assertive community treatment (FACT) in the
community for people with SMI. FACT can intensify (e.g. provide more intensive treatment in
the form of daily home visits, crisis care at home, more intensive evidence-based
psycho-social and pharmacological treatments) or provide less intensive treatment depending
on client need. It can also provide less intensive care during non-crisis periods, offering
routine home treatment where a combination of psychological and pharmacological treatments
(e.g. cognitive behavioral therapy, motivational interviewing, family-based interventions)
are offered, as well as care processes (reviewing recovery and crisis/treatment plans, and
the clients' Wellness Recovery Action Plan), and social care interventions (assistance in
obtaining or maintaining employment, looking for reasonable accommodation options).
Care offered in this project in the intervention condition will be provided by a
multidisciplinary community mental health team (CMHT), consisting of a diverse set of
professionals including psychiatrists, psychologists, nurses, and social workers, that
deliver integrated medical and social care that are focused on (symptomatic-, functional- and
personal-) recovery.
CMHTs will provide home-based treatment inclusive of crisis resolution services and
procedures for early recognition of sub-clinical psychosis and bipolar disorder, ACT, and
intensive case management. Integrated care (i.e. health and social care interventions) will
be provided to all clients. Furthermore, health and social care evidence-based interventions
for severe mental illnesses will be employed during home treatment, such as family-based
interventions, motivational interviewing, and cognitive behavioral therapies, combined with
medication management and identifying employment (paid and unpaid options) and support in
finding and maintaining this employment, (Wellness Recovery Action Plan (WRAP) recovery
groups and housing opportunities.
Comparison condition: Usual care Health care settings and their providers randomized to the
control condition receive usual care.
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