PsychosisNCT04778085
Young People and Illness Management and Recovery (IMR)
An observational study of Psychosis and Bipolar Disorder, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The study is a combined clinical patient outcome study and a health-services research sub-study. Illness management and recovery (IMR) constitutes an evidence-based practice with 11 modules focusing on personal recovery developed for adults with severe mental health illnesses. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Psychosis, Bipolar Disorder, Other Diagnoses and Conditions
- What is being tested?
- Illness management and recovery and Semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 9 Mar 2021to 30 Jun 2022
- Phase
- Observational
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients between 13-17 years of age suffering from or having symptoms of psychosis or bipolar disorders, and who participate in an IMR treatment group at one of the 4 (out of 7) outpatient clinics in the hospitals catchment area, and who are able to give informed consent. Up to 8 inpatients or previous inpatients between 13- 17 years of age suffering from various diagnoses will be invited to participate in a pilot focus-group interview. Trained clinicians and clinicians in training contribute to the implementation in the outpatient clinics together with clinic leaders and other clinicians.
Who may be able to join
- Outpatient units:
- Included in the IMR group in one of the outpatient clinics
- Able to give informed consent
- Inpatient unit (focus group):
- 13-17 years of age
- Current or previous patient
Show all 12Show fewer
- Able to understand and speak Norwegian
- Able to give informed consent
- IMR therapist leading IMR treatment groups in one of the participating outpatient clinics
- Trained or training in IMR
- Employed at the Department for Child and Adolescent Mental Health Services at Akershus University Hospital.
- Employed at the Department for Child and Adolescent Mental Health Services at Akershus University Hospital.
Who cannot join
- Younger than 13 years
- Mental retardation
- Manic phase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Young People's Experiences of Illness Management and Recovery (IMR) - an Explorative Study
The study is a combined clinical patient outcome study and a health-services research sub-study. Illness management and recovery (IMR) constitutes an evidence-based practice with 11 modules focusing on personal recovery developed for adults with severe mental health illnesses. IMR can be offered in groups or individually, once a week for 10-12 months.
Little is known about how young people experience the utility of IMR treatment groups in child and adolescent mental health outpatient clinics. The primary aim is to explore in-depth how the participants experience the utility of the IMR approach. The health research sub-study will provide new insights into the IMR implementation process in outpatient clinics for adolescents.
Read the detailed description
IMR has previously been implemented for adolescents in an inpatient unit in the hospital's catchment area. In order to offer the same treatment to all young patients, IMR treatment groups will be established in 4 out of 7 outpatient clinics in the hospital's catchment area. Participants belonging to the clinics in which no IMR treatment groups are being established will be invited to participate in IMR groups in clinics nearby.
The primary aim is to gain new insight into how young people experience the utility of IMR treatment groups conducted in outpatient practices and, if relevant, which changes could be made to adapt IMR more to young people. To explore how the participants experience the utility of IMR treatment groups, a qualitative focus-group study, consisting of a maximum of 5 focus-group interviews will be conducted. The participants in each IMR treatment group will be offered treatment once a week up to 10-12 months. To establish an IMR treatment group a minimum of 4 patients and a maximum of 8 participants must participate. Participants are mainly being included in the IMR treatment groups at the two primary admissions to each treatment group. Thus, some of the participants in the focus-groups may have participated in IMR groups for less than 10-12 months.
Secondary outcomes are related to fidelity to the model and the extent to which IMR treatment groups are implemented at an organizational level. The treatment groups will be led by trained IMR-therapists employed in inpatient units, together with therapists in training who are employed in outpatient clinics. Leaders and other clinicians in the outpatient clinics will contribute knowledge about the extent to which core components of IMR are being implemented, as well as information relating to quality improvement and individual adjustment. Two of the out-patient clinics in which no IMR group is being established will be included in the sub-study. The clinics will receive written feedback after each measurement time to support quality improvement.
The goal is to include up to 48 participants receiving IMR treatment in outpatient clinics. Up to 8 hospitalized participants will participate in a pilot focus-group interview. In the sub-study, a maximum of 16 IMR therapists, trained and in training, and up to 24 staff members will be invited to participate.
- Conditions
- Psychosis, Bipolar Disorder, Other Diagnoses and Conditions
- Being tested
- Illness management and recovery, Semi-structured interviews
- Keywords
- Psychosis
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder
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
Treatment given in groups, weekly for 10-12 months.
Semi-structured interviewsOther
Semi-structured individual or group interviews conducted three times with staff on each participating outpatient clinic.
| Study group | Role | What they receive |
|---|---|---|
| IMR patients | Patients from outpatient clinics receiving IMR from trained IMR therapists and IMR therapists in training. Receives: Behavioral: Illness management and recovery | |
| IMR therapists and other staff | Clinic leaders, IMR therapists and other staff participating in semi-structured individual or group interviews. Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus-group interview aiming to explore the significance of the participant's own understanding of and knowledge about the disorder.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
Measured: End of treatment group, on average 11 months.
Focus-group interview aiming to explore the impact of the IMR treatment on dealing with everyday life.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
Measured: End of treatment group, on average 11 months.
Focus-group interview aiming to explore the importance of meeting other young people in the same situation.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
Measured: End of treatment group, on average 11 months.
Secondary outcomes (4)
The Illness Management and Recovery Scale (IMRS)
A 15-item scale that assesses illness self-management on a 5-point Likert scale where 5 indicates full self-management and 0 indicates no self-management. The scale measures consumer behavior relating to core components in the IMR program. The scale includes parallel clinician and consumer versions. Participants participating in IMR groups for less than 10-12 months will attend fewer measuring times.
Measured: Baseline (0 months), 6 and 12 months.
The Illness Management Fidelity Scale
Assesses the degree of fidelity with 13 items on a 5-point Likert scale where 5 indicates full implementation and 0 indicates no implementation. Filled in by researchers on the basis of a semistructured interview with staff members.
Measured: Baseline (0 months), 6 and 12 months.
General Organizational Index
A 12-item scale measuring organizational outcome of implementation, on a 5-point Likert scale where 5 indicates full implementation and 0 indicates no implementation. The scale is filled in by researchers on the basis of a semi-structured interview with staff members.
Measured: Baseline (0 months), 6 and 12 months.
Attendance registration
The number of sessions the patients are attending in the IMR treatment group.
Measured: Baseline (0 months), 3, 6, 9 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start9 Mar 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: As anticipated by the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Lise Holmesland, University Hospital, Akershus
- Investigators
- Anne-Lise Holmesland, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778085
- Sponsor's protocol ID
- 20/09657
- Status last verified
- Sep 2022
- First submitted
- 14 Feb 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young People's Experiences of Illness Management and Recovery (IMR) - an Explorative Study
- ClinicalTrials.gov ID
- NCT04778085
- Acronym / sponsor ID
- 20/09657
- Conditions
- Psychosis, Bipolar Disorder, Other Diagnoses and Conditions
- Keywords
- Psychosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As anticipated by the protocol
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Mar 2021 (actual)
- 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 study is a combined clinical patient outcome study and a health-services research sub-study. Illness management and recovery (IMR) constitutes an evidence-based practice with 11 modules focusing on personal recovery developed for adults with severe mental health illnesses. IMR can be offered in groups or individually, once a week for 10-12 months.
Little is known about how young people experience the utility of IMR treatment groups in child and adolescent mental health outpatient clinics. The primary aim is to explore in-depth how the participants experience the utility of the IMR approach. The health research sub-study will provide new insights into the IMR implementation process in outpatient clinics for adolescents.
Detailed description
IMR has previously been implemented for adolescents in an inpatient unit in the hospital's catchment area. In order to offer the same treatment to all young patients, IMR treatment groups will be established in 4 out of 7 outpatient clinics in the hospital's catchment area. Participants belonging to the clinics in which no IMR treatment groups are being established will be invited to participate in IMR groups in clinics nearby.
The primary aim is to gain new insight into how young people experience the utility of IMR treatment groups conducted in outpatient practices and, if relevant, which changes could be made to adapt IMR more to young people. To explore how the participants experience the utility of IMR treatment groups, a qualitative focus-group study, consisting of a maximum of 5 focus-group interviews will be conducted. The participants in each IMR treatment group will be offered treatment once a week up to 10-12 months. To establish an IMR treatment group a minimum of 4 patients and a maximum of 8 participants must participate. Participants are mainly being included in the IMR treatment groups at the two primary admissions to each treatment group. Thus, some of the participants in the focus-groups may have participated in IMR groups for less than 10-12 months.
Secondary outcomes are related to fidelity to the model and the extent to which IMR treatment groups are implemented at an organizational level. The treatment groups will be led by trained IMR-therapists employed in inpatient units, together with therapists in training who are employed in outpatient clinics. Leaders and other clinicians in the outpatient clinics will contribute knowledge about the extent to which core components of IMR are being implemented, as well as information relating to quality improvement and individual adjustment. Two of the out-patient clinics in which no IMR group is being established will be included in the sub-study. The clinics will receive written feedback after each measurement time to support quality improvement.
The goal is to include up to 48 participants receiving IMR treatment in outpatient clinics. Up to 8 hospitalized participants will participate in a pilot focus-group interview. In the sub-study, a maximum of 16 IMR therapists, trained and in training, and up to 24 staff members will be invited to participate.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMR patients | – | Behavioral: Illness management and recoveryPatients from outpatient clinics receiving IMR from trained IMR therapists and IMR therapists in training. |
| IMR therapists and other staff | – | Other: Semi-structured interviewsClinic leaders, IMR therapists and other staff participating in semi-structured individual or group interviews. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients between 13-17 years of age suffering from or having symptoms of psychosis or bipolar disorders, and who participate in an IMR treatment group at one of the 4 (out of 7) outpatient clinics in the hospitals catchment area, and who are able to give informed consent. Up to 8 inpatients or previous inpatients between 13- 17 years of age suffering from various diagnoses will be invited to participate in a pilot focus-group interview. Trained clinicians and clinicians in training contribute to the implementation in the outpatient clinics together with clinic leaders and other clinicians.
Key inclusion criteria (12 listed)
- Included in the IMR group in one of the outpatient clinics
- Able to give informed consent
- 13-17 years of age
- Current or previous patient
- Able to understand and speak Norwegian
Key exclusion criteria (3 listed)
- Younger than 13 years
- Mental retardation
- Manic phase
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: IMRTreatment given in groups, weekly for 10-12 months. | Behavioural | IMR patients |
| Semi-structured interviewsSemi-structured individual or group interviews conducted three times with staff on each participating outpatient clinic. | Other | IMR therapists and other staff |
Primary outcome
Focus-group interview aiming to explore the significance of the participant's own understanding of and knowledge about the disorder.
Time frame: End of treatment group, on average 11 months.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
Focus-group interview aiming to explore the impact of the IMR treatment on dealing with everyday life.
Time frame: End of treatment group, on average 11 months.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
Focus-group interview aiming to explore the importance of meeting other young people in the same situation.
Time frame: End of treatment group, on average 11 months.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
4 secondary outcomes
The Illness Management and Recovery Scale (IMRS)
Time frame: Baseline (0 months), 6 and 12 months.
The Illness Management Fidelity Scale
Time frame: Baseline (0 months), 6 and 12 months.
General Organizational Index
Time frame: Baseline (0 months), 6 and 12 months.
Attendance registration
Time frame: Baseline (0 months), 3, 6, 9 and 12 months.
Results and safety
The study was stopped early (reason given: As anticipated by the protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- 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.
Anne-Lise Holmesland, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and Bipolar Disorder, 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 12 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Sep 2022. 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 was stopped early (reason given: As anticipated by the protocol). Results are not available in the source record.
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?
Focus-group interview aiming to explore the significance of the participant's own understanding of and knowledge about the disorder. (time frame: End of treatment group, on average 11 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2022.