Self-Injurious BehaviorBASNCT02985047
Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide
A study testing Brief Admission in people with Self-Injurious Behavior and Suicidal Ideation, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of the study is to test a standardized version of brief admission (BA) through randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a crisis management model for individuals with recurrent self-harm, including suicide attempts and at least three symptoms of Borderline… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Brief Admission
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2015to 10 Aug 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current episodes of self-harm and/or recurrent suicidality.
- Fulfilling at least three criteria for borderline personality disorder.
- Admitted to psychiatric hospital for acute care for at least 7 days or presenting to the psychiatric emergency department at least 3 times during the last six months.
Who cannot join
- No regular contact with outpatient psychiatric services.
- Homelessness. Housing crises are outside the scope of this RCT.
- Medical disorder from other organs that significantly contributes to inclusion criteria (e.g. if self-harm only occurs during episodes of hypoglycemia in a diabetic patient).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide
The purpose of the study is to test a standardized version of brief admission (BA) through randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a crisis management model for individuals with recurrent self-harm, including suicide attempts and at least three symptoms of Borderline Personality disorder. Participants will be allocated to BA + Treatment as Usual (TAU) or TAU.
Read the detailed description
When individuals with recurrent self-harm and suicidal behaviour seek acute admission to hospital due to a crisis and associated increased suicidal ideation, recommendations for clinical care are still conflicting. The risk for iatrogenic effects of inpatient care are considerable, and long hospital admissions without a clear treatment structure may predict decompensation in functioning. This has resulted in a clinical practice of avoiding admission for individuals diagnosed with Borderline Personality Disorder (BPD).
Brief admission (BA) as an intervention has a longstanding history in the delivery of mental health services in the Netherlands. The core elements of brief admission were determined through consultation with Dutch researchers, interviews with individuals with experience, Dutch clinicians familiar with Brief Admission, and local guidelines from hospitals familiar with implementing this crisis management intervention. Core elements of the intervention were standardized into a protocol, and an educational manual was developed to train clinicians involved in the trial. An objectively rated fidelity measure was developed in order to ensure adherence.
- Conditions
- Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted, Borderline Personality Disorder, Emergency Services, Psychiatric
- Being tested
- Brief Admission
- Keywords
- Brief admission, admission, deliberate self-harm, self-harm
- Medical subject headings
- Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief AdmissionOther
Also called Brukarstyrd Inläggning (Swedish)
Participants randomised to Brief admission (BA) will participate in a negotiation together with their out-patient clinician and a representative from the ward. The aim of the negotiation is to form an individualised contract defining how BA will work for them. After signing the contract, will have the possibility to admit themselves to hospital according to the procedure stated in the contract.
| Study group | Role | What they receive |
|---|---|---|
| Brief Admission | Experimental | Participants randomised to Brief admission (BA) will have the possibility of admitting themselves to hospital for a maximum duration of three consecutive days at a maximum frequency of three times per month. Apart from BA they have access to all psychiatric care that they would have if they had not participated in the study (including general admission to hospital). Receives: Other: Brief Admission |
| Control | No intervention | Participants randomized to Treatment as Usual will receive no intervention from the study protocol, except the baseline assessments and repeated assessments administered on the same schedule as described above for the treatment group. They will not be given the evaluation measures that are specific to the intervention. Participants have access to all psychiatric care that they would have if they had not participated in the study (including general admission to hospital). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with hospital admission
Number of days with Brief admission, general admission, forced (involuntary) admission
Measured: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Secondary outcomes (10)
Frequency of forced acts (e.g. restraints and forced medication)
Measured: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Individuals' Experiences of the intervention
Outcome from the questionnaires developed for the method: Individual's Experience Scale (IES)
Measured: Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.
Clinicians' Experiences of the intervention
Outcome from the questionnaires developed for the method: Clinician's Experience Scale (CES)
Measured: Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.
Frequency of all self-harming behaviours including suicide attempts
Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
Measured: Change in frequency between baseline, 6 months and 12 months prospectively.
Severity of self-harming behaviours
Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
Measured: Change in severity between baseline, 6 months and 12 months prospectively.
Level of functioning in activities of daily life
The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
Measured: Change in ratings between baseline, 6 months and 12 months prospectively.
Ability to cope effectively with life stress
The Brief COPE
Measured: Change in ratings between baseline, 6 months and 12 months prospectively.
Ability to regulate emotions
The Difficulties in Emotion Regulation Scale
Measured: Change in ratings between baseline, 6 months and 12 months prospectively.
Global psychiatric symptoms
Outcome from Clinical Global Impression Severity Scale
Measured: Change in ratings between baseline, 6 months and 12 months prospectively.
Satisfaction with health care
Client Satisfaction Questionnaire (CSQ)
Measured: Change in ratings between baseline, 6 months and 12 months prospectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start1 Sep 2015
- Primary completion30 Jun 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Self-Injurious BehaviorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Radboud University Medical Center
- Responsible party
- Principal investigator, Sofie Westling, Region Skane
- Investigators
- Sofie Westling, MD PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985047
- Sponsor's protocol ID
- 2014/570
- Acronym
- BAS
- Status last verified
- Aug 2018
- First submitted
- 25 Nov 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793Westling S, Daukantaite D, Liljedahl SI, Oh Y, Westrin A, Flyckt L, Helleman M. Effect of Brief Admission to Hospital by Self-referral for Individuals Who Self-harm and Are at Risk of Suicide: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jun 5;2(6):e195463. doi: 10.1001/jamanetworkopen.2019.5463.
PubMed 31173128Helleman M, Lundh LG, Liljedahl SI, Daukantaite D, Westling S. Individuals' experiences with brief admission during the implementation of the brief admission skane RCT, a qualitative study. Nord J Psychiatry. 2018 Jul;72(5):380-386. doi: 10.1080/08039488.2018.1467966. Epub 2018 Apr 27.
PubMed 29703119Liljedahl SI, Helleman M, Daukantaite D, Westrin A, Westling S. A standardized crisis management model for self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder: The Brief Admission Skane randomized controlled trial protocol (BASRCT). BMC Psychiatry. 2017 Jun 15;17(1):220. doi: 10.1186/s12888-017-1371-6.
PubMed 28619050
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide
- ClinicalTrials.gov ID
- NCT02985047
- Acronym / sponsor ID
- BAS / 2014/570
- Conditions
- Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted, Borderline Personality Disorder, Emergency Services, Psychiatric
- Keywords
- Brief admission, admission, deliberate self-harm, self-harm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Radboud University Medical Center
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 7 Dec 2016 (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 the study is to test a standardized version of brief admission (BA) through randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a crisis management model for individuals with recurrent self-harm, including suicide attempts and at least three symptoms of Borderline Personality disorder. Participants will be allocated to BA + Treatment as Usual (TAU) or TAU.
Detailed description
When individuals with recurrent self-harm and suicidal behaviour seek acute admission to hospital due to a crisis and associated increased suicidal ideation, recommendations for clinical care are still conflicting. The risk for iatrogenic effects of inpatient care are considerable, and long hospital admissions without a clear treatment structure may predict decompensation in functioning. This has resulted in a clinical practice of avoiding admission for individuals diagnosed with Borderline Personality Disorder (BPD).
Brief admission (BA) as an intervention has a longstanding history in the delivery of mental health services in the Netherlands. The core elements of brief admission were determined through consultation with Dutch researchers, interviews with individuals with experience, Dutch clinicians familiar with Brief Admission, and local guidelines from hospitals familiar with implementing this crisis management intervention. Core elements of the intervention were standardized into a protocol, and an educational manual was developed to train clinicians involved in the trial. An objectively rated fidelity measure was developed in order to ensure adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Admission | Experimental | Other: Brief AdmissionParticipants randomised to Brief admission (BA) will have the possibility of admitting themselves to hospital for a maximum duration of three consecutive days at a maximum frequency of three times per month. Apart from BA they have access to all psychiatric care that they would have if they had not participated in the study (including general admission to hospital). |
| Control | No intervention | –Participants randomized to Treatment as Usual will receive no intervention from the study protocol, except the baseline assessments and repeated assessments administered on the same schedule as described above for the treatment group. They will not be given the evaluation measures that are specific to the intervention. Participants have access to all psychiatric care that they would have if they had not participated in the study (including general admission to hospital). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Current episodes of self-harm and/or recurrent suicidality.
- Fulfilling at least three criteria for borderline personality disorder.
- Admitted to psychiatric hospital for acute care for at least 7 days or presenting to the psychiatric emergency department at least 3 times during the last six months.
Key exclusion criteria (3 listed)
- No regular contact with outpatient psychiatric services.
- Homelessness. Housing crises are outside the scope of this RCT.
- Medical disorder from other organs that significantly contributes to inclusion criteria (e.g. if self-harm only occurs during episodes of hypoglycemia in a diabetic patient).
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 |
|---|---|---|
| Brief AdmissionAlso: Brukarstyrd Inläggning (Swedish)Participants randomised to Brief admission (BA) will participate in a negotiation together with their out-patient clinician and a representative from the ward. The aim of the negotiation is to form an individualised contract defining how BA will work for them. After signing the contract, will have the possibility to admit themselves to hospital according to the procedure stated in the contract. | Other | Brief Admission |
Primary outcome
Number of days with hospital admission
Time frame: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Number of days with Brief admission, general admission, forced (involuntary) admission
10 secondary outcomes
Frequency of forced acts (e.g. restraints and forced medication)
Time frame: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Individuals' Experiences of the intervention
Time frame: Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.
Clinicians' Experiences of the intervention
Time frame: Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.
Frequency of all self-harming behaviours including suicide attempts
Time frame: Change in frequency between baseline, 6 months and 12 months prospectively.
Severity of self-harming behaviours
Time frame: Change in severity between baseline, 6 months and 12 months prospectively.
Level of functioning in activities of daily life
Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
Ability to cope effectively with life stress
Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
Ability to regulate emotions
Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
Global psychiatric symptoms
Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
Satisfaction with health care
Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
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 28 Aug 2018.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Derived from this study: PubMed 31173128Westling S, Daukantaite D, Liljedahl SI, Oh Y, Westrin A, Flyckt L, Helleman M. Effect of Brief Admission to Hospital by Self-referral for Individuals Who Self-harm and Are at Risk of Suicide: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jun 5;2(6):e195463. doi: 10.1001/jamanetworkopen.2019.5463.
- Derived from this study: PubMed 29703119Helleman M, Lundh LG, Liljedahl SI, Daukantaite D, Westling S. Individuals' experiences with brief admission during the implementation of the brief admission skane RCT, a qualitative study. Nord J Psychiatry. 2018 Jul;72(5):380-386. doi: 10.1080/08039488.2018.1467966. Epub 2018 Apr 27.
- Derived from this study: PubMed 28619050Liljedahl SI, Helleman M, Daukantaite D, Westrin A, Westling S. A standardized crisis management model for self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder: The Brief Admission Skane randomized controlled trial protocol (BASRCT). BMC Psychiatry. 2017 Jun 15;17(1):220. doi: 10.1186/s12888-017-1371-6.
- 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.
Sofie Westling, MD 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?
A study testing Brief Admission in people with Self-Injurious Behavior and Suicidal Ideation, 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 3 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: finished, as of the sponsor's last update on 28 Aug 2018. 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?
Number of days with hospital admission (time frame: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively). 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 NCT02985047, which also lists 5 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 28 Aug 2018.