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

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ClinicalTrials.gov Identifier: NCT02985047
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
Lund University
Radboud University Medical Center
Information provided by (Responsible Party):
Sofie Westling, Region Skane

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.

Condition or disease Intervention/treatment Phase
Self-Injurious Behavior Suicidal Ideation Suicide, Attempted Borderline Personality Disorder Emergency Services, Psychiatric Other: Brief Admission Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : August 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm Suicide

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).
Other: Brief Admission
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 Name: 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).



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985047


Locations
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Sweden
Division of Psychiatry, Region Skåne
Lund, Skåne, Sweden, 22185
Sponsors and Collaborators
Region Skane
Lund University
Radboud University Medical Center
Investigators
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Principal Investigator: Sofie Westling, MD PhD Region Skåne
  Study Documents (Full-Text)

Documents provided by Sofie Westling, Region Skane:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sofie Westling, MD, PhD, Region Skane
ClinicalTrials.gov Identifier: NCT02985047    
Other Study ID Numbers: 2014/570
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sofie Westling, Region Skane:
Brief admission
admission
deliberate self-harm
self-harm
Additional relevant MeSH terms:
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Emergencies
Suicide
Personality Disorders
Borderline Personality Disorder
Suicidal Ideation
Self-Injurious Behavior
Suicide, Attempted
Disease Attributes
Pathologic Processes
Behavioral Symptoms
Mental Disorders