- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985047
Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide (BAS)
Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Skåne
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Lund, Skåne, Sweden, 22185
- Division of Psychiatry, Region Skåne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Brief Admission
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).
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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 Names:
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No Intervention: Control
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Number of days with Brief admission, general admission, forced (involuntary) admission
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Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
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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.
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Outcome from the questionnaires developed for the method: Individual's Experience Scale (IES)
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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.
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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.
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Outcome from the questionnaires developed for the method: Clinician's Experience Scale (CES)
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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.
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Frequency of all self-harming behaviours including suicide attempts
Time Frame: Change in frequency between baseline, 6 months and 12 months prospectively.
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Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
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Change in frequency between baseline, 6 months and 12 months prospectively.
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Severity of self-harming behaviours
Time Frame: Change in severity between baseline, 6 months and 12 months prospectively.
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Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
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Change in severity between baseline, 6 months and 12 months prospectively.
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Level of functioning in activities of daily life
Time Frame: Change in ratings between baseline, 6 months and 12 months prospectively.
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The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
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Change in ratings between baseline, 6 months and 12 months prospectively.
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Ability to cope effectively with life stress
Time Frame: Change in ratings between baseline, 6 months and 12 months prospectively.
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The Brief COPE
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Change in ratings between baseline, 6 months and 12 months prospectively.
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Ability to regulate emotions
Time Frame: Change in ratings between baseline, 6 months and 12 months prospectively.
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The Difficulties in Emotion Regulation Scale
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Change in ratings between baseline, 6 months and 12 months prospectively.
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Global psychiatric symptoms
Time Frame: Change in ratings between baseline, 6 months and 12 months prospectively.
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Outcome from Clinical Global Impression Severity Scale
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Change in ratings between baseline, 6 months and 12 months prospectively.
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Satisfaction with health care
Time Frame: Change in ratings between baseline, 6 months and 12 months prospectively.
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Client Satisfaction Questionnaire (CSQ)
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Change in ratings between baseline, 6 months and 12 months prospectively.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sofie Westling, MD PhD, Region Skåne
Publications and helpful links
General Publications
- Storebo 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.
- 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.
- Westling 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. Erratum In: JAMA Netw Open. 2019 Oct 2;2(10):e1913724.
- Helleman 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.
- Liljedahl 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/570
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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