Suicidal IdeationNCT04962217
Experiences of Brief Admission From the Perspective of Family and Significant Others
An observational study of Suicidal Ideation and Self Injurious Behavior Without Suicidal Intent, run by Region Skane at 1 site in Sweden.
Trial summary
As a result of a randomized controlled trial (NCT02985047) BA is continuously offered to persons with self-harm at risk for suicide in Skåne, Sweden. This qualitative inductive study aims to provide experiences among family members, carers and significant others of Brief Admission by self-referral for self-harming and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Suicidal Ideation, Self Injurious Behavior Without Suicidal Intent, Self-Harm, Deliberate
- What is being tested?
- Semi-structured interviews
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2021to 31 Dec 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Family member, carer or significant other as defined by persons with access to Brief Admission by self-referral through one of the psychiatric departments in Skåne, Sweden (Lund, Malmö, Helsingborg or Kristianstad).
Who may be able to join
- Family member, carer or significant other as defined by persons with access to Brief Admission by self-referral through one of the psychiatric departments in Skåne, Sweden (Lund, Malmö, Helsingborg or Kristianstad).
- At least 18 years of age.
- Able to consent to study participation through written and oral information.
- Given consent to participate
Who cannot join
- below the age of 18.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Psykiatri och habilitering, Region Skåne
Lund, Skåne County, 22185
About this study
Official title: Experiences Among Family Members, Carers and Significant Others of Brief Admission by Self-referral for Self-harming and Suicidal Persons: a Qualitative Study
As a result of a randomized controlled trial (NCT02985047) BA is continuously offered to persons with self-harm at risk for suicide in Skåne, Sweden. This qualitative inductive study aims to provide experiences among family members, carers and significant others of Brief Admission by self-referral for self-harming and suicidal persons based on individual semi-structured interviews. Participants will be identified through suggestion from persons with an active BA contract. Interviews, estimated to last 30-60 minutes, will be analyzed by a phenomenological hermeneutic method or by content analysis depending on richness and depth in the interviews. Findings from this study will be published.
Read the detailed description
As a result of the randomized controlled trial evaluating BA in Skåne (NCT02985047), BA is since January 2019, continuously offered to persons with self-harm at risk for suicide in Skåne, Sweden. Parallel to the clinical trial qualitative interview studies have been performed on the experiences of BA, with participants during the pilot phase of the trial and among the most severely ill persons and from the viewpoint of psychiatric staff. The present study aims to complement the above-mentioned studies with analysis of real-life experiences of BA from the perspective of loved ones to persons with current access to BA. This is important since the persons close to those suffering from recurrent self-harm and suicidal ideation play an essential role in times of crisis and may beneficially contribute to motivation as well as effects of provided care.
In this qualitative inductive study individual semi-structured interviews will be held with family members, carers and significant others of persons with an active BA contract, who has given informed consent to participate. To identify potential informants, persons with an active BA contract, who have used BA within the last three months, at the wards in Lund, Malmö, Helsingborg or Kristianstad will be contacted and asked about contact information (name and telephone number) to a person close to them who may be contacted regarding inclusion in the present study. A variation of contract length (minimum one month since first signed contract) is strived for. The number of interviews will depend on the number of active contracts at the included wards and the proportion of those where potential participants may be contacted and who subsequently consent to participate, but with a maximum of 25 interviews. Interviews are estimated to be 30-60 minutes, and will be conducted in a calm place, chosen by the participant. Interviews will be performed by doctoral students in psychiatry and supervised by a senior researcher with experience of psychiatry and qualitative research. Interviews will be transcribed and analyzed by a phenomenological hermeneutic method or by content analysis depending on richness and depth in the interviews. Findings from this study will be published.
- Being tested
- Semi-structured interviews
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
Each participant will attend a 30-60 minute semi-structured interview conducted by the CI
What is being measured
The primary outcome is the main question the study is designed to answer.
Lived experiences
Data from semi-structured interviews
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Sofie Westling, Region Skane
- Investigators
- Sofie Westling, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962217
- Sponsor's protocol ID
- 2019-02557
- Other IDs
- 2019
- Status last verified
- Jan 2024
- First submitted
- 5 Jul 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have no ethical approval to share data from interviews.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences Among Family Members, Carers and Significant Others of Brief Admission by Self-referral for Self-harming and Suicidal Persons: a Qualitative Study
- ClinicalTrials.gov ID
- NCT04962217
- Acronym / sponsor ID
- 2019-02557
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Jul 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.
As a result of a randomized controlled trial (NCT02985047) BA is continuously offered to persons with self-harm at risk for suicide in Skåne, Sweden. This qualitative inductive study aims to provide experiences among family members, carers and significant others of Brief Admission by self-referral for self-harming and suicidal persons based on individual semi-structured interviews. Participants will be identified through suggestion from persons with an active BA contract. Interviews, estimated to last 30-60 minutes, will be analyzed by a phenomenological hermeneutic method or by content analysis depending on richness and depth in the interviews. Findings from this study will be published.
Detailed description
As a result of the randomized controlled trial evaluating BA in Skåne (NCT02985047), BA is since January 2019, continuously offered to persons with self-harm at risk for suicide in Skåne, Sweden. Parallel to the clinical trial qualitative interview studies have been performed on the experiences of BA, with participants during the pilot phase of the trial and among the most severely ill persons and from the viewpoint of psychiatric staff. The present study aims to complement the above-mentioned studies with analysis of real-life experiences of BA from the perspective of loved ones to persons with current access to BA. This is important since the persons close to those suffering from recurrent self-harm and suicidal ideation play an essential role in times of crisis and may beneficially contribute to motivation as well as effects of provided care.
In this qualitative inductive study individual semi-structured interviews will be held with family members, carers and significant others of persons with an active BA contract, who has given informed consent to participate. To identify potential informants, persons with an active BA contract, who have used BA within the last three months, at the wards in Lund, Malmö, Helsingborg or Kristianstad will be contacted and asked about contact information (name and telephone number) to a person close to them who may be contacted regarding inclusion in the present study. A variation of contract length (minimum one month since first signed contract) is strived for. The number of interviews will depend on the number of active contracts at the included wards and the proportion of those where potential participants may be contacted and who subsequently consent to participate, but with a maximum of 25 interviews. Interviews are estimated to be 30-60 minutes, and will be conducted in a calm place, chosen by the participant. Interviews will be performed by doctoral students in psychiatry and supervised by a senior researcher with experience of psychiatry and qualitative research. Interviews will be transcribed and analyzed by a phenomenological hermeneutic method or by content analysis depending on richness and depth in the interviews. Findings from this study will be published.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Family member, carer or significant other as defined by persons with access to Brief Admission by self-referral through one of the psychiatric departments in Skåne, Sweden (Lund, Malmö, Helsingborg or Kristianstad).
Key inclusion criteria (4 listed)
- Family member, carer or significant other as defined by persons with access to Brief Admission by self-referral through one of the psychiatric departments in Skåne, Sweden (Lund, Malmö, Helsingborg or Kristianstad).
- At least 18 years of age.
- Able to consent to study participation through written and oral information.
- Given consent to participate
Key exclusion criteria (1 listed)
- below the age of 18.
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 |
|---|---|---|
| Semi-structured interviewsEach participant will attend a 30-60 minute semi-structured interview conducted by the CI | Other | – |
Primary outcome
Lived experiences
Time frame: 60 minutes
Data from semi-structured interviews
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 31 Jan 2024.
- Individual participant dataSharing planned: Undecided. The investigators have no ethical approval to share data from interviews.
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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.
Sofie Westling, PhD principal investigator
Region Skane
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 Suicidal Ideation and Self Injurious Behavior Without Suicidal Intent, run by Region Skane at 1 site in Sweden.
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 1 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 31 Jan 2024. 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 Sweden. 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?
Lived experiences (time frame: 60 minutes). 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 31 Jan 2024.