- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01361698
Illness Management and Recovery (IMR) in Danish Community Mental Health Centres (IMR)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ballerup and Frederiksberg, Denmark
- Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Global Assessment of Function
Time Frame: 9 months and 21 months
|
9 months and 21 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PANSS
Time Frame: 9 and 21 months follow-up
|
Positive and Negative Syndrome Scale
|
9 and 21 months follow-up
|
|
IMR Scale
Time Frame: 9 and 21 months follow-up
|
9 and 21 months follow-up
|
|
|
Personal and Social Performance
Time Frame: 9 and 21 months
|
9 and 21 months
|
|
|
Hamilton Rating Scale for Depression
Time Frame: 9 & 21 months
|
9 & 21 months
|
|
|
Young Mania Rating Scale
Time Frame: 9 & 21 months
|
9 & 21 months
|
|
|
Mental Health Recovery Measure
Time Frame: 9 and 21 months
|
9 and 21 months
|
|
|
The Adult State Hope Scale
Time Frame: 9 and 21 months
|
9 and 21 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010B114
- IMR-DP-228-CT-59 (Registry Identifier: Copenhagen Trial Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
First Affiliated Hospital of Fujian Medical UniversityNot yet recruiting
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Newron Pharmaceuticals SPARecruitingTreatment-resistant SchizophreniaUnited States, India
-
All India Institute of Medical Sciences, BhubaneswarCompletedTreatment Resistant SchizophreniaIndia
-
Bradley LegaRecruiting
-
Central Institute of Mental Health, MannheimRecruitingSchizophrenia | Treatment Resistant SchizophreniaGermany
-
Shanghai Zhongze Therapeutics Co., Ltd.Yale UniversityNot yet recruiting
-
Ole Köhler-ForsbergAarhus University HospitalRecruiting
Clinical Trials on Illness Management and Recovery (IMR)
-
University Hospital, AkershusHelse Sor-Ost; RomeriksprosjektetCompletedMental Disorders | Mood Disorders | Schizophrenia | Bipolar Disorder | Affective Disorders, PsychoticNorway
-
University of WashingtonCompletedSchizophrenia | Bipolar Disorder | Severe Mental Illness
-
University Hospital, AkershusTerminatedBipolar Disorder | Psychosis | Other Diagnoses and ConditionsNorway
-
VA Office of Research and DevelopmentIndiana University; Dartmouth CollegeCompletedSchizophrenia | Schizo-affective DisorderUnited States
-
Oriana Arellano FaúndezActive, not recruitingSuicidal Ideation | Suicidal Ideation and BehaviorsChile
-
Yale UniversityNational Institute of Mental Health (NIMH)Completed
-
Yale UniversityNational Institute of Mental Health (NIMH); VA Connecticut Healthcare SystemCompletedSchizophrenia | Bipolar Disorder | Dual DiagnosisUnited States
-
Karolinska InstitutetDalarna County Council, SwedenActive, not recruitingPsychotic Disorders | Antisocial Personality Disorder | Substance Use Disorders | Forensic Psychology | Forensic NursingSweden
-
VA Office of Research and DevelopmentUniversity of California, San FranciscoCompletedStress Disorders, Post-TraumaticUnited States
-
Dartmouth-Hitchcock Medical CenterPatient-Centered Outcomes Research InstituteRecruiting