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Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide (BAS)

Primary Purpose

Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Brief Admission
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-Injurious Behavior focused on measuring Brief admission, admission, deliberate self-harm, self-harm

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Division of Psychiatry, Region Skåne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief Admission

Control

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Number of days with hospital admission
Number of days with Brief admission, general admission, forced (involuntary) admission

Secondary Outcome Measures

Frequency of forced acts (e.g. restraints and forced medication)
Individuals' Experiences of the intervention
Outcome from the questionnaires developed for the method: Individual's Experience Scale (IES)
Clinicians' Experiences of the intervention
Outcome from the questionnaires developed for the method: Clinician's Experience Scale (CES)
Frequency of all self-harming behaviours including suicide attempts
Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
Severity of self-harming behaviours
Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
Level of functioning in activities of daily life
The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
Ability to cope effectively with life stress
The Brief COPE
Ability to regulate emotions
The Difficulties in Emotion Regulation Scale
Global psychiatric symptoms
Outcome from Clinical Global Impression Severity Scale
Satisfaction with health care
Client Satisfaction Questionnaire (CSQ)

Full Information

First Posted
November 25, 2016
Last Updated
August 24, 2018
Sponsor
Region Skane
Collaborators
Lund University, Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02985047
Brief Title
Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide
Acronym
BAS
Official Title
Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Lund University, Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted, Borderline Personality Disorder, Emergency Services, Psychiatric
Keywords
Brief admission, admission, deliberate self-harm, self-harm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Admission
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Brief Admission
Other Intervention Name(s)
Brukarstyrd Inläggning (Swedish)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of days with hospital admission
Description
Number of days with Brief admission, general admission, forced (involuntary) admission
Time Frame
Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Secondary Outcome Measure Information:
Title
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
Title
Individuals' Experiences of the intervention
Description
Outcome from the questionnaires developed for the method: Individual's Experience Scale (IES)
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.
Title
Clinicians' Experiences of the intervention
Description
Outcome from the questionnaires developed for the method: Clinician's Experience Scale (CES)
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.
Title
Frequency of all self-harming behaviours including suicide attempts
Description
Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
Time Frame
Change in frequency between baseline, 6 months and 12 months prospectively.
Title
Severity of self-harming behaviours
Description
Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
Time Frame
Change in severity between baseline, 6 months and 12 months prospectively.
Title
Level of functioning in activities of daily life
Description
The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
Time Frame
Change in ratings between baseline, 6 months and 12 months prospectively.
Title
Ability to cope effectively with life stress
Description
The Brief COPE
Time Frame
Change in ratings between baseline, 6 months and 12 months prospectively.
Title
Ability to regulate emotions
Description
The Difficulties in Emotion Regulation Scale
Time Frame
Change in ratings between baseline, 6 months and 12 months prospectively.
Title
Global psychiatric symptoms
Description
Outcome from Clinical Global Impression Severity Scale
Time Frame
Change in ratings between baseline, 6 months and 12 months prospectively.
Title
Satisfaction with health care
Description
Client Satisfaction Questionnaire (CSQ)
Time Frame
Change in ratings between baseline, 6 months and 12 months prospectively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofie Westling, MD PhD
Organizational Affiliation
Region Skåne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Psychiatry, Region Skåne
City
Lund
State/Province
Skåne
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived
PubMed Identifier
32368793
Citation
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.
Results Reference
derived
PubMed Identifier
31173128
Citation
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.
Results Reference
derived
PubMed Identifier
29703119
Citation
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.
Results Reference
derived
PubMed Identifier
28619050
Citation
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.
Results Reference
derived

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Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide

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