Schizophrenia Clinical Trial
Official title:
Illness Management and Recovery (IMR) in Danish Community Mental Health Centres: Protocol of a Randomized, Assessor-blinded Multi-centre Clinical Trial of a Recovery-oriented Program for People With Schizophrenia or Bipolar Disorder
The aim of this trial is to evaluate the effectiveness of the Illness Management and Recovery program for people diagnosed with schizophrenia or bipolar disorder in according to their level of functioning.
Background: Illness Management and Recovery (IMR) is a curriculum-based psychosocial
intervention designed as structured program with a recovery-oriented approach. The aim of
IMR is to rehabilitate people with severe mental illnesses by helping them acquire knowledge
and skills in managing their illness and achieve personal recovery goals. Previous
randomised clinical trials indicate that IMR can be implemented with a good effect and a
high fidelity though further trials are crucial to demonstrate the potential effectiveness
of IMR.
Methods/Design: The trial design is a randomised, assessor-blinded, multi-centre, clinical
trial of the IMR program compared with treatment as usual for 200 participants diagnosed
with schizophrenia or bipolar disorder under the care of two community mental health centres
in the Capital Region of Denmark. The primary outcome is level of functioning at the end of
treatment and at follow-up 21 months after baseline. The secondary outcomes are disease
symptoms; use of alcohol/drugs; individual meaning of recovery; hope; hospital admissions
and out-patient psychiatric treatment at the end of treatment and at follow-up 21 months
after baseline.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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