Schizophrenia Clinical Trial
— IMROfficial 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.
Status | Completed |
Enrollment | 198 |
Est. completion date | December 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adults (age 18+) - both sexes - associated with one of the two participating community mental health centres - diagnosed following the ICD-10 criteria of schizophrenia or bipolar disorder - able to speak and understand Danish - giving informed consent verbally and in writing Exclusion Criteria: - have a guardian or a forensic psychiatric arrangement - comorbidity with the ICD-10 criteria of the diagnoses of dementia or mental retardation - a large-scale substance abuse - if later on the abuse is under control inclusion in the trial will be possible - a current home of supported housing - since the treatment as usual given to this group of patients is significant different from patients living independently - a current involvement in a psycho-educational course - patients are eligible for participation in the trial after the psycho-educational course has ended if they meet the inclusion criteria at this point - not given informed consent. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg | Ballerup and Frederiksberg |
Lead Sponsor | Collaborator |
---|---|
Mental Health Centre Copenhagen | Mental Health Services in the Capital Region, Denmark, The Danish Health Fund |
Denmark,
Mueser KT, Corrigan PW, Hilton DW, Tanzman B, Schaub A, Gingerich S, Essock SM, Tarrier N, Morey B, Vogel-Scibilia S, Herz MI. Illness management and recovery: a review of the research. Psychiatr Serv. 2002 Oct;53(10):1272-84. Review. — View Citation
Mueser KT, Meyer PS, Penn DL, Clancy R, Clancy DM, Salyers MP. The Illness Management and Recovery program: rationale, development, and preliminary findings. Schizophr Bull. 2006 Oct;32 Suppl 1:S32-43. Epub 2006 Aug 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global Assessment of Function | 9 months and 21 months | No | |
Secondary | PANSS | Positive and Negative Syndrome Scale | 9 and 21 months follow-up | No |
Secondary | IMR Scale | 9 and 21 months follow-up | No | |
Secondary | Personal and Social Performance | 9 and 21 months | No | |
Secondary | Hamilton Rating Scale for Depression | 9 & 21 months | No | |
Secondary | Young Mania Rating Scale | 9 & 21 months | No | |
Secondary | Mental Health Recovery Measure | 9 and 21 months | No | |
Secondary | The Adult State Hope Scale | 9 and 21 months | No |
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