Clinical trial NCT01361698: Illness Management and Recovery (IMR) in Danish Community Mental Health Centres
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Keywords: recovery
illness management
rehabilitation
mental illness
psychosocial intervention
Clinical recovery (increase in functioning, decrease in symptoms)
Personal recovery (Hope, optimism, living a fulfilling life)
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Health Fund
First posted: 2011-05-27
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global Assessment of Function
timeFrame: 9 months and 21 months
Secondary outcomes:
measure: PANSS
timeFrame: 9 and 21 months follow-up
measure: IMR Scale
timeFrame: 9 and 21 months follow-up
measure: Personal and Social Performance
timeFrame: 9 and 21 months
measure: Hamilton Rating Scale for Depression
timeFrame: 9 & 21 months
measure: Young Mania Rating Scale
timeFrame: 9 & 21 months
measure: Mental Health Recovery Measure
timeFrame: 9 and 21 months
measure: The Adult State Hope Scale
timeFrame: 9 and 21 months
Other outcomes:
Locations:
city: Ballerup and Frederiksberg
country: Denmark
facility: Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg
Study officials:
References:
citation: 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. doi: 10.1176/appi.ps.53.10.1272.
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(Suppl 1):S32-43. doi: 10.1093/schbul/sbl022. Epub 2006 Aug 9.
citation: Jensen SB, Dalum HS, Korsbek L, Hjorthoj C, Mikkelsen JH, Thomsen K, Kistrup K, Olander M, Lindschou J, Mueser KT, Nordentoft M, Eplov LF. Illness management and recovery: one-year follow-up of a randomized controlled trial in Danish community mental health centers: long-term effects on clinical and personal recovery. BMC Psychiatry. 2019 Feb 11;19(1):65. doi: 10.1186/s12888-019-2048-0.
citation: Dalum HS, Korsbek L, Mikkelsen JH, Thomsen K, Kistrup K, Olander M, Hansen JL, Nordentoft M, Eplov LF. Illness management and recovery (IMR) in Danish community mental health centres. Trials. 2011 Aug 17;12:195. doi: 10.1186/1745-6215-12-195.