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

February 2, 2026 updated by: Lene Falgaard Eplov, Amager Hospital

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

May 26, 2011

First Posted (Estimated)

May 27, 2011

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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