NCT02985047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

November 25, 2016

Last Update Submit

August 24, 2018

Conditions

Self-Injurious BehaviorSuicidal IdeationSuicide, AttemptedBorderline Personality DisorderEmergency Services, Psychiatric

Keywords

Brief admissionadmissiondeliberate self-harmself-harm

Outcome Measures

Primary Outcomes (1)

  • Number of days with hospital admission

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

    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)

    Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively

  • Individuals' Experiences of the intervention

    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

    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

    Change in frequency between baseline, 6 months and 12 months prospectively.

  • Severity of self-harming behaviours

    Change in severity between baseline, 6 months and 12 months prospectively.

  • +5 more secondary outcomes

Study Arms (2)

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).

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).

Interventions

Brief AdmissionOTHER

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.

Also known as: Brukarstyrd Inläggning (Swedish)
Brief Admission

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • No regular contact with outpatient psychiatric services.
  • Homelessness. Housing crises are outside the scope of this RCT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Psychiatry, Region Skåne

Lund, Skåne County, 22185, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 33884617DERIVED

  • 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.

    PMID: 32368793DERIVED

  • 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.

    PMID: 31173128DERIVED

  • 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.

    PMID: 29703119DERIVED

  • 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.

    PMID: 28619050DERIVED

MeSH Terms

Conditions

Self-Injurious BehaviorSuicidal IdeationSuicide, AttemptedBorderline Personality Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicidePersonality DisordersMental Disorders

Study Officials

  • Sofie Westling, MD PhD

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 25, 2016

First Posted

December 7, 2016

Study Start

September 1, 2015

Primary Completion

June 30, 2018

Study Completion

August 10, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)