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

Primary Purpose

Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Illness Management and Recovery (IMR)
Sponsored by
Mental Health Centre Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring recovery, illness management, rehabilitation, mental illness, psychosocial intervention, Clinical recovery (increase in functioning, decrease in symptoms), Personal recovery (Hope, optimism, living a fulfilling life)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IMR program

Treatment as usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Global Assessment of Function

Secondary Outcome Measures

PANSS
Positive and Negative Syndrome Scale
IMR Scale
Personal and Social Performance
Hamilton Rating Scale for Depression
Young Mania Rating Scale
Mental Health Recovery Measure
The Adult State Hope Scale

Full Information

First Posted
May 25, 2011
Last Updated
February 7, 2016
Sponsor
Mental Health Centre Copenhagen
Collaborators
Mental Health Services in the Capital Region, Denmark, The Danish Health Fund
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1. Study Identification

Unique Protocol Identification Number
NCT01361698
Brief Title
Illness Management and Recovery (IMR) in Danish Community Mental Health Centres
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mental Health Centre Copenhagen
Collaborators
Mental Health Services in the Capital Region, Denmark, The Danish Health Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMR program
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Illness Management and Recovery (IMR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global Assessment of Function
Time Frame
9 months and 21 months
Secondary Outcome Measure Information:
Title
PANSS
Description
Positive and Negative Syndrome Scale
Time Frame
9 and 21 months follow-up
Title
IMR Scale
Time Frame
9 and 21 months follow-up
Title
Personal and Social Performance
Time Frame
9 and 21 months
Title
Hamilton Rating Scale for Depression
Time Frame
9 & 21 months
Title
Young Mania Rating Scale
Time Frame
9 & 21 months
Title
Mental Health Recovery Measure
Time Frame
9 and 21 months
Title
The Adult State Hope Scale
Time Frame
9 and 21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg
City
Ballerup and Frederiksberg
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12364675
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.
Results Reference
background
PubMed Identifier
16899534
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.
Results Reference
background
PubMed Identifier
30744590
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.
Results Reference
derived
PubMed Identifier
21849024
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.
Results Reference
derived
Links:
URL
http://www.trialsjournal.com/content/12/1/195
Description
Illness management and recovery (IMR) in Danish community mental health centres (Study protocol)

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

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