First Episode PsychosisNCT01753284
First Episode Psychosis and Pathway to Care in Nordland
An observational study of First Episode Psychosis, run by Nordlandssykehuset HF.
Trial summary
First episode psychosis patients often experiences treatment delay. This reduces their prospects for recovery and makes unnecessary burdens for them and their carers. A better understanding of help seeking intentions is required, and has not been explored in a county like Nordland, Norway, with long distances and… Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- First Episode Psychosis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2018
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients experiencing first and multiple episode psychosis carers siblings
Who may be able to join
- age 16-35,
- understand and speak Norwegian
- able to give consent
- no learning disabilities
Who cannot join
None listed.
About this study
Official title: Patients and Carers Experiences With First Episode Psychosis and Pathway to Care in Nordland: A Qualitative Study
First episode psychosis patients often experiences treatment delay. This reduces their prospects for recovery and makes unnecessary burdens for them and their carers. A better understanding of help seeking intentions is required, and has not been explored in a county like Nordland, Norway, with long distances and challenging access to health services. The purpose of this study is to explore the process of help seeking, including how patients and their careers discover and understand the psychotic symptoms. Research exploring the impact on families mainly focuses on parents' experiences, and there are less studies focusing on experiences and needs of siblings. This study will therefore explore siblings' experiences separate from their parents. Methods will be qualitative interviews with patients, their carers and siblings. Analysis will be influenced by Grounded theory.
- Conditions
- First Episode Psychosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experience
Measured: up to 100 weeks
Carers experiences
Measured: up to 100 weeks
Siblings experiences
Measured: up to 100 weeks
Pathway to care
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753284
- Sponsor's protocol ID
- 2012/1650(REK)
- Status last verified
- Apr 2018
- First submitted
- 17 Dec 2012
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients and Carers Experiences With First Episode Psychosis and Pathway to Care in Nordland: A Qualitative Study
- ClinicalTrials.gov ID
- NCT01753284
- Acronym / sponsor ID
- 2012/1650(REK)
- Conditions
- First Episode Psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Dec 2012 (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.
First episode psychosis patients often experiences treatment delay. This reduces their prospects for recovery and makes unnecessary burdens for them and their carers. A better understanding of help seeking intentions is required, and has not been explored in a county like Nordland, Norway, with long distances and challenging access to health services. The purpose of this study is to explore the process of help seeking, including how patients and their careers discover and understand the psychotic symptoms. Research exploring the impact on families mainly focuses on parents' experiences, and there are less studies focusing on experiences and needs of siblings. This study will therefore explore siblings' experiences separate from their parents. Methods will be qualitative interviews with patients, their carers and siblings. Analysis will be influenced by Grounded theory.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients experiencing first and multiple episode psychosis carers siblings
Key inclusion criteria (4 listed)
- age 16-35,
- understand and speak Norwegian
- able to give consent
- no learning disabilities
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient experience
Time frame: up to 100 weeks
Carers experiences
Time frame: up to 100 weeks
Siblings experiences
Time frame: up to 100 weeks
Pathway to care
Time frame: up to 100 weeks
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 13 May 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of First Episode Psychosis, run by Nordlandssykehuset HF.
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 4 inclusion and 0 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient experience (time frame: up to 100 weeks). The study lists 4 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 13 May 2019.