SchizophreniaIMRNCT01361698
Illness Management and Recovery (IMR) in Danish Community Mental Health Centres
A study testing Illness Management and Recovery (IMR) in people with Schizophrenia and Bipolar Disorder, run by Amager Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- Illness Management and Recovery (IMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Community Mental Health Center Ballerup and Community Mental Health Center Frederiksberg
Ballerup and Frederiksberg
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- Illness Management and Recovery (IMR)
- 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)
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Illness Management and Recovery (IMR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| IMR program | Experimental | 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. Receives: Behavioral: Illness Management and Recovery (IMR) |
| Treatment as usual | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Function
Measured: 9 months and 21 months
Secondary outcomes (7)
PANSS
Positive and Negative Syndrome Scale
Measured: 9 and 21 months follow-up
IMR Scale
Measured: 9 and 21 months follow-up
Personal and Social Performance
Measured: 9 and 21 months
Hamilton Rating Scale for Depression
Measured: 9 & 21 months
Young Mania Rating Scale
Measured: 9 & 21 months
Mental Health Recovery Measure
Measured: 9 and 21 months
The Adult State Hope Scale
Measured: 9 and 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, The Danish Health Fund
- Responsible party
- Principal investigator, Lene Falgaard Eplov, Amager Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361698
- Sponsor's protocol ID
- 2010B114
- Other IDs
- IMR-DP-228-CT-59
- Acronym
- IMR
- Status last verified
- Feb 2026
- First submitted
- 25 May 2011
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 12364675Mueser 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.
PubMed 16899534Jensen 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.
PubMed 30744590Dalum 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.
PubMed 21849024
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01361698
- Acronym / sponsor ID
- IMR / 2010B114
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, The Danish Health Fund
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMR program | Experimental | Behavioral: Illness Management and Recovery (IMR)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. |
| Treatment as usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | IMR program |
Primary outcome
Global Assessment of Function
Time frame: 9 months and 21 months
7 secondary outcomes
PANSS
Time frame: 9 and 21 months follow-up
IMR Scale
Time frame: 9 and 21 months follow-up
Personal and Social Performance
Time frame: 9 and 21 months
Hamilton Rating Scale for Depression
Time frame: 9 & 21 months
Young Mania Rating Scale
Time frame: 9 & 21 months
Mental Health Recovery Measure
Time frame: 9 and 21 months
The Adult State Hope Scale
Time frame: 9 and 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 12364675Mueser 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.
- Background: PubMed 16899534Mueser 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.
- Derived from this study: PubMed 30744590Jensen 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.
- Derived from this study: PubMed 21849024Dalum 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.
- Illness management and recovery (IMR) in Danish community mental health centres (Study protocol)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Illness Management and Recovery (IMR) in people with Schizophrenia and Bipolar Disorder, run by Amager Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Assessment of Function (time frame: 9 months and 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01361698, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.