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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Schizophrenia, Bipolar Disorder

Intervention / Treatment
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* Behavioral: Illness Management and Recovery (IMR)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMR program<br>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)<br>* 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.<br>|
| No Intervention: Treatment as usual<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Function |  | 9 months and 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS | Positive and Negative Syndrome Scale | 9 and 21 months follow-up | 
| IMR Scale |  | 9 and 21 months follow-up | 
| Personal and Social Performance |  | 9 and 21 months | 
| Hamilton Rating Scale for Depression |  | 9 & 21 months | 
| Young Mania Rating Scale |  | 9 & 21 months | 
| Mental Health Recovery Measure |  | 9 and 21 months | 
| The Adult State Hope Scale |  | 9 and 21 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recovery, illness management, rehabilitation, mental illness, psychosocial intervention, Clinical recovery (increase in functioning, decrease in symptoms), Personal recovery (Hope, optimism, living a fulfilling life)