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

August 24, 2018 updated by: Sofie Westling, Region Skane

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.

Study Overview

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

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Skåne
      • Lund, Skåne, Sweden, 22185
        • Division of Psychiatry, Region Skåne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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).
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:
  • Brukarstyrd Inläggning (Swedish)
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).

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
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 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
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.
Outcome from the questionnaires developed for the method: Individual's Experience Scale (IES)
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.
Outcome from the questionnaires developed for the method: Clinician's Experience Scale (CES)
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.
Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
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.
Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
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.
The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
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.
The Brief COPE
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.
The Difficulties in Emotion Regulation Scale
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.
Outcome from Clinical Global Impression Severity Scale
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.
Client Satisfaction Questionnaire (CSQ)
Change in ratings between baseline, 6 months and 12 months prospectively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Sofie Westling, MD PhD, Region Skåne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

August 10, 2018

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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