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Completed

NCT Number: NCT02985047

Brief Admission Skane: Replacing 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Psychiatry, Region Skåne

Lund, Skåne County, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Brief Admission

Other

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. Ability to cope effectively with life stress

    Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.

    The Brief COPE

  8. Ability to regulate emotions

    Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.

    The Difficulties in Emotion Regulation Scale

  9. Global psychiatric symptoms

    Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.

    Outcome from Clinical Global Impression Severity Scale

  10. Satisfaction with health care

    Time frame: Change in ratings between baseline, 6 months and 12 months prospectively.

    Client Satisfaction Questionnaire (CSQ)

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University
  • Radboud University Medical Center

Registry information

Official study title

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

Acronym: BAS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2016
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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