Mental Health ImpairmentNCT04138459
Recovery - a Collaborative Project
An observational study of Mental Health Impairment and Substance Abuse, run by University College of Southeast Norway at 1 site in Norway.
Trial summary
In Norway, official guidelines and policies state that recovery oriented services in the field of mental health and substance abuse services is a desirable goal. This collaborative research project aims to provide in-depth knowledge of how recovery oriented practices and collaboration in the mental health and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Impairment, Substance Abuse
- What is being tested?
- Not an interventional study. This is a qualitative, explorative study of recovery orientation of community mental health services
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 30 May 2019to 31 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults who have received community mental health and / or substance abuse services for the past year or longer, due to moderate or severe mental health and / or substance abuse problems.
Who may be able to join
- receives community mental health services due to mental health and /or substance abuse related problems
- Above 18 years old
Who cannot join
- Under the age of 18
- Mental health workers in the municipality, working in mental health and substance abuse services
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Trude G Klevan
Drammen
Trude G Klevan, 004735575420 ext. 004735575420, Trude.Goril.Klevan@usn.no
Marit Borg, 004747289487 ext. 004735575420, marit.borg@usn.no
About this study
Official title: Development of Recovery Oriented Practices, Knowledge and Collaboration in a Norwegian Municipality. An Explorative Study
In Norway, official guidelines and policies state that recovery oriented services in the field of mental health and substance abuse services is a desirable goal.
This collaborative research project aims to provide in-depth knowledge of how recovery oriented practices and collaboration in the mental health and substance abuse services in the municipality of New Drammen develop over a three-year period.
Read more
Using qualitative methods, the main aim of the study is to explore what recovery orientation of services in mental health and substance abuse presupposes and involves related to roles, collaboration and knowledge.
To explore these issues, service users will be interviewed together with their primary mental health professional.
The study will also apply observational fieldwork in order to observe recovery oriented practices between service users and professionals and between professionals.
An advisory group consisting of people with background as service users, mental health clinicians and service leaders will contribute throughout the project.
.
- Conditions
- Mental Health Impairment, Substance Abuse
- Being tested
- Not an interventional study. This is a qualitative, explorative study of recovery orientation of community mental health services
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not an interventional study. This is a qualitative, explorative study of recovery orientation of community mental health servicesOther
Explore recovery orientation of mental health services in a municipality through:
- Qualitative, in-depth interviews with service users and mental health professionals and
- Observational fieldwork
| Study group | Role | What they receive |
|---|---|---|
| Qualitative exploration | Ten community mental health service users will be interviewed with their most important mental health worker to explore how recovery orientation of services affects roles and collaboration. Receives: Other: Not an interventional study. This is a qualitative, explorative study of recovery orientation of community mental health services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contribute to the knowledge base on what recovery orientation of services involves
The anticipated outcome is to obtain insight on how recovery orientation of mental health services affects roles, knowledge and collaboration in a Norwegian municipality.
Measured: The aims of the study will be explored through interviews and fieldwork over an anticipated period of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start30 May 2019
- Primary completion15 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health ImpairmentStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College of Southeast Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Extrastiftelsen
- Responsible party
- Sponsor
- Investigators
- Heidi c Kapstad, PhD, Study chair, University of South-Eastern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138459
- Sponsor's protocol ID
- UCSNorway
- Status last verified
- Oct 2019
- First submitted
- 26 Feb 2019
- Last updated
- 24 Oct 2019
- 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 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Recovery Oriented Practices, Knowledge and Collaboration in a Norwegian Municipality. An Explorative Study
- ClinicalTrials.gov ID
- NCT04138459
- Acronym / sponsor ID
- UCSNorway
- Conditions
- Mental Health Impairment, Substance Abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College of Southeast NorwayUniversity, hospital or other
- Collaborators
- Extrastiftelsen
- Study start
- 30 May 2019 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Oct 2019 (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.
In Norway, official guidelines and policies state that recovery oriented services in the field of mental health and substance abuse services is a desirable goal.
This collaborative research project aims to provide in-depth knowledge of how recovery oriented practices and collaboration in the mental health and substance abuse services in the municipality of New Drammen develop over a three-year period.
Using qualitative methods, the main aim of the study is to explore what recovery orientation of services in mental health and substance abuse presupposes and involves related to roles, collaboration and knowledge.
To explore these issues, service users will be interviewed together with their primary mental health professional.
The study will also apply observational fieldwork in order to observe recovery oriented practices between service users and professionals and between professionals.
An advisory group consisting of people with background as service users, mental health clinicians and service leaders will contribute throughout the project.
.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative exploration | – | Other: Not an interventional study. This is a qualitative, explorative study of recovery orientation of community mental health servicesTen community mental health service users will be interviewed with their most important mental health worker to explore how recovery orientation of services affects roles and collaboration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have received community mental health and / or substance abuse services for the past year or longer, due to moderate or severe mental health and / or substance abuse problems.
Key inclusion criteria (2 listed)
Key exclusion criteria (2 listed)
- Mental health workers in the municipality, working in mental health and substance abuse services
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 |
|---|---|---|
| Not an interventional study. This is a qualitative, explorative study of recovery orientation of community mental health servicesExplore recovery orientation of mental health services in a municipality through: 1. Qualitative, in-depth interviews with service users and mental health professionals and 2. Observational fieldwork | Other | Qualitative exploration |
Primary outcome
Contribute to the knowledge base on what recovery orientation of services involves
Time frame: The aims of the study will be explored through interviews and fieldwork over an anticipated period of 2 years
The anticipated outcome is to obtain insight on how recovery orientation of mental health services affects roles, knowledge and collaboration in a Norwegian municipality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- 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.
Heidi c Kapstad, PhD study chair
University of South-Eastern Norway
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 Mental Health Impairment and Substance Abuse, run by University College of Southeast Norway 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 2 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: status not confirmed, as of the sponsor's last update on 24 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trude G Klevan, PhD (004735575420 ext. 004735575420, Trude.Goril.Klevan@usn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contribute to the knowledge base on what recovery orientation of services involves (time frame: The aims of the study will be explored through interviews and fieldwork over an anticipated period of 2 years). 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 24 Oct 2019.