<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02985047</url>
  </required_header>
  <id_info>
    <org_study_id>2014/570</org_study_id>
    <nct_id>NCT02985047</nct_id>
  </id_info>
  <brief_title>Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide</brief_title>
  <acronym>BAS</acronym>
  <official_title>Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to test a standardized version of brief admission (BA) through&#xD;
      randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a&#xD;
      crisis management model for individuals with recurrent self-harm, including suicide attempts&#xD;
      and at least three symptoms of Borderline Personality disorder. Participants will be&#xD;
      allocated to BA + Treatment as Usual (TAU) or TAU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When individuals with recurrent self-harm and suicidal behaviour seek acute admission to&#xD;
      hospital due to a crisis and associated increased suicidal ideation, recommendations for&#xD;
      clinical care are still conflicting. The risk for iatrogenic effects of inpatient care are&#xD;
      considerable, and long hospital admissions without a clear treatment structure may predict&#xD;
      decompensation in functioning. This has resulted in a clinical practice of avoiding admission&#xD;
      for individuals diagnosed with Borderline Personality Disorder (BPD).&#xD;
&#xD;
      Brief admission (BA) as an intervention has a longstanding history in the delivery of mental&#xD;
      health services in the Netherlands. The core elements of brief admission were determined&#xD;
      through consultation with Dutch researchers, interviews with individuals with experience,&#xD;
      Dutch clinicians familiar with Brief Admission, and local guidelines from hospitals familiar&#xD;
      with implementing this crisis management intervention. Core elements of the intervention were&#xD;
      standardized into a protocol, and an educational manual was developed to train clinicians&#xD;
      involved in the trial. An objectively rated fidelity measure was developed in order to ensure&#xD;
      adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">August 10, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days with hospital admission</measure>
    <time_frame>Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively</time_frame>
    <description>Number of days with Brief admission, general admission, forced (involuntary) admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of forced acts (e.g. restraints and forced medication)</measure>
    <time_frame>Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individuals' Experiences of the intervention</measure>
    <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.</time_frame>
    <description>Outcome from the questionnaires developed for the method: Individual's Experience Scale (IES)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinicians' Experiences of the intervention</measure>
    <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.</time_frame>
    <description>Outcome from the questionnaires developed for the method: Clinician's Experience Scale (CES)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of all self-harming behaviours including suicide attempts</measure>
    <time_frame>Change in frequency between baseline, 6 months and 12 months prospectively.</time_frame>
    <description>Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of self-harming behaviours</measure>
    <time_frame>Change in severity between baseline, 6 months and 12 months prospectively.</time_frame>
    <description>Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of functioning in activities of daily life</measure>
    <time_frame>Change in ratings between baseline, 6 months and 12 months prospectively.</time_frame>
    <description>The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to cope effectively with life stress</measure>
    <time_frame>Change in ratings between baseline, 6 months and 12 months prospectively.</time_frame>
    <description>The Brief COPE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to regulate emotions</measure>
    <time_frame>Change in ratings between baseline, 6 months and 12 months prospectively.</time_frame>
    <description>The Difficulties in Emotion Regulation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global psychiatric symptoms</measure>
    <time_frame>Change in ratings between baseline, 6 months and 12 months prospectively.</time_frame>
    <description>Outcome from Clinical Global Impression Severity Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with health care</measure>
    <time_frame>Change in ratings between baseline, 6 months and 12 months prospectively.</time_frame>
    <description>Client Satisfaction Questionnaire (CSQ)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Self-Injurious Behavior</condition>
  <condition>Suicidal Ideation</condition>
  <condition>Suicide, Attempted</condition>
  <condition>Borderline Personality Disorder</condition>
  <condition>Emergency Services, Psychiatric</condition>
  <arm_group>
    <arm_group_label>Brief Admission</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brief Admission</intervention_name>
    <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.</description>
    <arm_group_label>Brief Admission</arm_group_label>
    <other_name>Brukarstyrd Inläggning (Swedish)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current episodes of self-harm and/or recurrent suicidality.&#xD;
&#xD;
          -  Fulfilling at least three criteria for borderline personality disorder.&#xD;
&#xD;
          -  Admitted to psychiatric hospital for acute care for at least 7 days or presenting to&#xD;
             the psychiatric emergency department at least 3 times during the last six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No regular contact with outpatient psychiatric services.&#xD;
&#xD;
          -  Homelessness. Housing crises are outside the scope of this RCT.&#xD;
&#xD;
          -  Medical disorder from other organs that significantly contributes to inclusion&#xD;
             criteria (e.g. if self-harm only occurs during episodes of hypoglycemia in a diabetic&#xD;
             patient).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sofie Westling, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Skåne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Psychiatry, Region Skåne</name>
      <address>
        <city>Lund</city>
        <state>Skåne</state>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>August 24, 2018</last_update_submitted>
  <last_update_submitted_qc>August 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Skane</investigator_affiliation>
    <investigator_full_name>Sofie Westling</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Brief admission</keyword>
  <keyword>admission</keyword>
  <keyword>deliberate self-harm</keyword>
  <keyword>self-harm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
    <mesh_term>Borderline Personality Disorder</mesh_term>
    <mesh_term>Self-Injurious Behavior</mesh_term>
    <mesh_term>Suicide, Attempted</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT02985047/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02985047
org study id: 2014/570
nct id: NCT02985047
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 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
description: Number of days with Brief admission, general admission, forced (involuntary) admission
measure: 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
measure: 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.
description: Outcome from the questionnaires developed for the method: Individual's Experience Scale (IES)
measure: 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.
description: Outcome from the questionnaires developed for the method: Clinician's Experience Scale (CES)
measure: Frequency of all self-harming behaviours including suicide attempts
time frame: Change in frequency between baseline, 6 months and 12 months prospectively.
description: Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
measure: Severity of self-harming behaviours
time frame: Change in severity between baseline, 6 months and 12 months prospectively.
description: Outcome from Five Self-Harm Behaviour Groupings Measure (5S-HM)
measure: Level of functioning in activities of daily life
time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
description: The World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
measure: Ability to cope effectively with life stress
time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
description: The Brief COPE
measure: Ability to regulate emotions
time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
description: The Difficulties in Emotion Regulation Scale
measure: Global psychiatric symptoms
time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
description: Outcome from Clinical Global Impression Severity Scale
measure: Satisfaction with health care
time frame: Change in ratings between baseline, 6 months and 12 months prospectively.
description: Client Satisfaction Questionnaire (CSQ)
arm group label: Brief Admission
arm group type: Experimental
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 group label: Control
arm group type: No Intervention
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: Brief Admission
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.
arm group label: Brief Admission
other name: Brukarstyrd Inläggning (Swedish)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sofie Westling, MD PhD
role: Principal Investigator
affiliation: Region Skåne
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Skane
investigator full name: Sofie Westling
investigator title: MD, PhD
mesh term: Emergencies
mesh term: Suicide
mesh term: Personality Disorders
mesh term: Suicidal Ideation
mesh term: Borderline Personality Disorder
mesh term: Self-Injurious Behavior
mesh term: Suicide, Attempted
sharing ipd: No
provided document: 