Illness Management and Recovery (IMR) in Danish Community Mental Health Centres (IMR)
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|ClinicalTrials.gov Identifier: NCT01361698|
Recruitment Status : Completed
First Posted : May 27, 2011
Last Update Posted : February 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Bipolar Disorder||Behavioral: Illness Management and Recovery (IMR)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
Experimental: IMR program
The program is organised into 11 curriculum topic areas: recovery strategies, practical facts about mental illness, the stress-vulnerability model, building social support, using medication effectively, drug and alcohol use, reducing relapses, healthy lifestyle, coping with stress, coping with problems and symptoms, and getting your needs met in the mental health system. 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.
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.
No Intervention: Treatment as usual
Patients randomised to the control group will get 'treatment as usual' only. This means individual adapted interdisciplinary treatment including medication, individual support, occupational therapy, psycho-education and group therapy.
- Global Assessment of Function [ Time Frame: 9 months and 21 months ]
- PANSS [ Time Frame: 9 and 21 months follow-up ]Positive and Negative Syndrome Scale
- IMR Scale [ Time Frame: 9 and 21 months follow-up ]
- Personal and Social Performance [ Time Frame: 9 and 21 months ]
- Hamilton Rating Scale for Depression [ Time Frame: 9 & 21 months ]
- Young Mania Rating Scale [ Time Frame: 9 & 21 months ]
- Mental Health Recovery Measure [ Time Frame: 9 and 21 months ]
- The Adult State Hope Scale [ Time Frame: 9 and 21 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361698
|Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg|
|Ballerup and Frederiksberg, Denmark|