Illness Management and Recovery (IMR) in Danish Community Mental Health Centres

Schizophrenia Clinical Trial

— IMR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361698
• Other study ID #: 2010B114
• Secondary ID: IMR-DP-228-CT-59
• Status: Completed
• Phase: N/A
• First received: May 25, 2011
• Last updated: February 7, 2016
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Mental Health Centre Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Intervention

Behavioral:
• Illness Management and Recovery (IMR)
In this Danish trial IMR will be implemented in group format with 10 patients assigned to each group and two IMR facilitators, and the IMR program will require nine months of weekly sessions to complete.

Locations

Country	Name	City	State
Denmark	Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg	Ballerup and Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Centre Copenhagen	Mental Health Services in the Capital Region, Denmark, The Danish Health Fund

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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

Outcome

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

External Links

•   Illness management and recovery (IMR) in Danish community mental health centres (Study protocol)