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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mental Health Services in the Capital Region, Denmark
The Danish Health Fund
Information provided by (Responsible Party):
Lene Falgaard Eplov, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier:
NCT01361698
First received: May 25, 2011
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Schizophrenia
Bipolar Disorder
Behavioral: Illness Management and Recovery (IMR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mental Health Centre Copenhagen:

Primary Outcome Measures:
  • Global Assessment of Function [ Time Frame: 9 months and 21 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PANSS [ Time Frame: 9 and 21 months follow-up ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale

  • IMR Scale [ Time Frame: 9 and 21 months follow-up ] [ Designated as safety issue: No ]
  • Personal and Social Performance [ Time Frame: 9 and 21 months ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Depression [ Time Frame: 9 & 21 months ] [ Designated as safety issue: No ]
  • Young Mania Rating Scale [ Time Frame: 9 & 21 months ] [ Designated as safety issue: No ]
  • Mental Health Recovery Measure [ Time Frame: 9 and 21 months ] [ Designated as safety issue: No ]
  • The Adult State Hope Scale [ Time Frame: 9 and 21 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361698

Locations
Denmark
Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg
Ballerup and Frederiksberg, Denmark
Sponsors and Collaborators
Mental Health Centre Copenhagen
Mental Health Services in the Capital Region, Denmark
The Danish Health Fund
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lene Falgaard Eplov, Senior Consultant, PhD, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT01361698     History of Changes
Other Study ID Numbers: 2010B114, IMR-DP-228-CT-59
Study First Received: May 25, 2011
Last Updated: July 3, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Mental Health Centre Copenhagen:
recovery
illness management
rehabilitation
mental illness
psychosocial intervention
Clinical recovery (increase in functioning, decrease in symptoms)
Personal recovery (Hope, optimism, living a fulfilling life)

Additional relevant MeSH terms:
Schizophrenia
Disease
Bipolar Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Affective Disorders, Psychotic
Mood Disorders

ClinicalTrials.gov processed this record on September 18, 2014