Bipolar DisorderNCT02077829
Implementation of Illness Management and Recovery in Mental Health Services
A study testing Illness Management and Recovery in people with Bipolar Disorder and Schizophrenia, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of this study is to examine the barriers and facilitators of implementing Illness Management and Recovery (IMR) in Norwegian mental health services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Schizophrenia, Affective Disorders, Psychotic
- What is being tested?
- Illness Management and Recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2014to Jun 2015
- 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
- Voluntary recruited therapists in the participating mental health services
- trained and consulted in IMR
- Adults (18+)
- Associated with one of the participating mental health services
- symptoms on or diagnosis of severe mental illness with or without drug abuse
- giving informed consent verbally and in writing
Who cannot join
- Patients with acute risk of suicidal behaviour
- not able to communicate in Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Illness Management and Recovery in Mental Health Services: Facilitators and Barriers in the Implementation Process.
The purpose of this study is to examine the barriers and facilitators of implementing Illness Management and Recovery (IMR) in Norwegian mental health services.
Read the detailed description
IMR is an evidence-based practice developed for people with severe mental illnesses. It is based on the principles of recovery to help people set individual meaningful goals for their lives and gain illness self-management skills and thereby contribute to their individual recovery-process. IMR can be given individually or in groups, once a week for 10-12 months.
In this project the investigators will implement Illness Management and Recovery (IMR) in mental health services. The implementation strategy are carried out according to the IMR toolkits which include informational and training materials, implementation recommendations, and fidelity scales to facilitate use of the model in routine practices. The implementation process and outcome will be of main focus.
The study has an observational prospective cohort design. 30 therapists from 9 different mental health services will be trained and supervised in IMR. The investigators aim to enrol 40 patients. The primary outcome is therapists' fidelity to the model and organisational implementation outcome. Secondary outcomes are patients' level of functioning and hope.
- Conditions
- Bipolar Disorder, Schizophrenia, Affective Disorders, Psychotic, Mood Disorders, Mental Disorders
- Being tested
- Illness Management and Recovery
- Keywords
- Implementation process, implementation strategy, Implementation research, evidence based practice, recovery, Illness management and recovery
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Affective Disorders, Psychotic, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Illness Management and RecoveryBehavioural
Also called IMR
Evidence-based practice given individually or in groups, weekly for 10-12 months.
| Study group | Role | What they receive |
|---|---|---|
| IMR therapists, IMR patients | Other | 30 voluntary therapists from 9 mental health services will be trained and coached in IMR.
40 patients from the 9 mental health services will receive Illness Management and Recovery from the therapists in training. Receives: Behavioral: Illness Management and Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Illness Management Fidelity Scale (SAMHSA, 2009)
Assesses the degree of fidelity with 13 items on a 5-point likert scale where 5 indicates full implementation and 0 indicates no implementation
Measured: 12 months
Secondary outcomes (4)
The Illness Management & Recovery Treatment Integrity Scale (IT-IS) (McGuire et al., 2012
A 16-item scale measuring clinicians' faithful replication of the model
Measured: 12 months
The Adult State Hope Scale (Snyder et al., 1996)
A 6-item self-report scale of patients' hope and optimism
Measured: 12 months
The Illness Management and Recovery Scale (SAMHSA, 2009)
Assessing patients' recovery outcomes in the IMR program with 15 items.
Measured: About 11 months after start of intervention
General Organizational Index (SAMHSA, 2009)
A 12-item scale measuring organisational outcome of implementation by common agency practices that support evidence-based practices
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Romeriksprosjektet, Helse Sor-Ost
- Responsible party
- Principal investigator, Kristin Sverdvik Heiervang, University Hospital, Akershus
- Investigators
- Kristin S. Heiervang, Ph.D., Principal investigator, Akershus University Hospital, Research & Development, Mental Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077829
- Sponsor's protocol ID
- IMR 01/2014
- Other IDs
- 2013/2035b
- Status last verified
- Jan 2016
- First submitted
- 25 Feb 2014
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Egeland KM, Hauge MI, Ruud T, Ogden T, Heiervang KS. Significance of Leaders for Sustained Use of Evidence-Based Practices: A Qualitative Focus-Group Study with Mental Health Practitioners. Community Ment Health J. 2019 Nov;55(8):1344-1353. doi: 10.1007/s10597-019-00430-8. Epub 2019 Jun 12.
PubMed 31190179Egeland KM, Ruud T, Ogden T, Fardig R, Lindstrom JC, Heiervang KS. How to implement Illness Management and Recovery (IMR) in mental health service settings: evaluation of the implementation strategy. Int J Ment Health Syst. 2017 Jan 23;11:13. doi: 10.1186/s13033-017-0120-z. eCollection 2017.
PubMed 28127388
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Illness Management and Recovery in Mental Health Services: Facilitators and Barriers in the Implementation Process.
- ClinicalTrials.gov ID
- NCT02077829
- Acronym / sponsor ID
- IMR 01/2014
- Conditions
- Bipolar Disorder, Schizophrenia, Affective Disorders, Psychotic, Mood Disorders, Mental Disorders
- Keywords
- Implementation process, implementation strategy, Implementation research, evidence based practice, recovery, Illness management and recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Romeriksprosjektet, Helse Sor-Ost
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Mar 2014 (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 purpose of this study is to examine the barriers and facilitators of implementing Illness Management and Recovery (IMR) in Norwegian mental health services.
Detailed description
IMR is an evidence-based practice developed for people with severe mental illnesses. It is based on the principles of recovery to help people set individual meaningful goals for their lives and gain illness self-management skills and thereby contribute to their individual recovery-process. IMR can be given individually or in groups, once a week for 10-12 months.
In this project the investigators will implement Illness Management and Recovery (IMR) in mental health services. The implementation strategy are carried out according to the IMR toolkits which include informational and training materials, implementation recommendations, and fidelity scales to facilitate use of the model in routine practices. The implementation process and outcome will be of main focus.
The study has an observational prospective cohort design. 30 therapists from 9 different mental health services will be trained and supervised in IMR. The investigators aim to enrol 40 patients. The primary outcome is therapists' fidelity to the model and organisational implementation outcome. Secondary outcomes are patients' level of functioning and hope.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMR therapists, IMR patients | Other | Behavioral: Illness Management and Recovery30 voluntary therapists from 9 mental health services will be trained and coached in IMR. 40 patients from the 9 mental health services will receive Illness Management and Recovery from the therapists in training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary recruited therapists in the participating mental health services
- trained and consulted in IMR
- Adults (18+)
- Associated with one of the participating mental health services
- symptoms on or diagnosis of severe mental illness with or without drug abuse
Key exclusion criteria (2 listed)
- Patients with acute risk of suicidal behaviour
- not able to communicate in Norwegian
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 RecoveryAlso: IMREvidence-based practice given individually or in groups, weekly for 10-12 months. | Behavioural | IMR therapists, IMR patients |
Primary outcome
The Illness Management Fidelity Scale (SAMHSA, 2009)
Time frame: 12 months
Assesses the degree of fidelity with 13 items on a 5-point likert scale where 5 indicates full implementation and 0 indicates no implementation
4 secondary outcomes
The Illness Management & Recovery Treatment Integrity Scale (IT-IS) (McGuire et al., 2012
Time frame: 12 months
The Adult State Hope Scale (Snyder et al., 1996)
Time frame: 12 months
The Illness Management and Recovery Scale (SAMHSA, 2009)
Time frame: About 11 months after start of intervention
General Organizational Index (SAMHSA, 2009)
Time frame: 12 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 12 Jan 2016.
- Derived from this study: PubMed 31190179Egeland KM, Hauge MI, Ruud T, Ogden T, Heiervang KS. Significance of Leaders for Sustained Use of Evidence-Based Practices: A Qualitative Focus-Group Study with Mental Health Practitioners. Community Ment Health J. 2019 Nov;55(8):1344-1353. doi: 10.1007/s10597-019-00430-8. Epub 2019 Jun 12.
- Derived from this study: PubMed 28127388Egeland KM, Ruud T, Ogden T, Fardig R, Lindstrom JC, Heiervang KS. How to implement Illness Management and Recovery (IMR) in mental health service settings: evaluation of the implementation strategy. Int J Ment Health Syst. 2017 Jan 23;11:13. doi: 10.1186/s13033-017-0120-z. eCollection 2017.
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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.
Kristin S. Heiervang, Ph.D. principal investigator
Akershus University Hospital, Research & Development, Mental Health Services
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 in people with Bipolar Disorder and Schizophrenia, run by University Hospital, Akershus at 1 site in Norway.
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 2 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 12 Jan 2016. 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 Norway. 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?
The Illness Management Fidelity Scale (SAMHSA, 2009) (time frame: 12 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 NCT02077829, which also lists 2 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 12 Jan 2016.