<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/NCT03768674</url>
  </required_header>
  <id_info>
    <org_study_id>2019/FO244009</org_study_id>
    <secondary_id>2018/1124</secondary_id>
    <nct_id>NCT03768674</nct_id>
  </id_info>
  <brief_title>Extreme Challenges - Psychopathology &amp; Treatment Experiences Among Severly Selfharming Inpatients in Norway</brief_title>
  <official_title>English Title: Extreme Challenges - Psychopathology, Treatment Organization and Experiences Among Psychiatric Inpatients With Severe Self-harming Behavior in Norway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Extrastiftelsen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Advisory Unit for Personality Psychiatry (NAPP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Research Group Personality Psychiatry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Network for personality-focused treatment</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Centre for Suicide Research and Prevention (NSSF)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regional Centre for Violence and Traumatic Stress (RVTS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regional Centre for Early Intervention Psychosis (TIPS SØrØst)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regional collaborators and users</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who self-harm are a heterogeneous population. Outpatient treatments structured for&#xD;
      borderline personality disorder are often recommended and hospitalization kept to a minimum.&#xD;
      However, few studies have focused on the most severe, complex conditions with extreme suicide&#xD;
      risk. A recent national investigation from Norway (2017) demonstrated a far larger cohort of&#xD;
      extensively hospitalized inpatients with extreme self-harming behaviors than was expected&#xD;
      (N=427) - identified in all health regions. Reported challenges were high-risk situations,&#xD;
      severe medical sequelae, difficult collaborations across services, and uncertainty about&#xD;
      psychiatric diagnoses.&#xD;
&#xD;
      Severe, often bizarre, self-harm is thus a major challenge for both patients and health&#xD;
      services. In hospitals, safety measures can involve restrictions and involuntary regimes. As&#xD;
      research on this target population is sparse, the current project seeks further understanding&#xD;
      of complex conditions - psychopathology, treatment experiences and service collaboration.&#xD;
&#xD;
      The project is a national, multi-center cooperation including patients in psychiatric&#xD;
      hospitals in all health regions. It is cross sectional. Data is based on diagnostic&#xD;
      interviews, patients' self-reported symptoms and both patients and service providers&#xD;
      treatment experiences. The inclusion period for inpatients (N=300) and a comparison sample of&#xD;
      outpatients (N=300) is one year.&#xD;
&#xD;
      The target group is inpatients with extreme hospitalization and severe self-mutilation. A&#xD;
      comparison group is patients with personality pathology attending outpatient treatments.&#xD;
      Recruitment is across health regions.&#xD;
&#xD;
      Aim 1: Investigate psychopathology of patients in the target population and compare to a&#xD;
      clinical sample admitted to outpatient treatment&#xD;
&#xD;
      Aim 2: Investigate personality functioning in the target population and compare to a clinical&#xD;
      sample admitted to outpatient treatment&#xD;
&#xD;
      Aim 3: a) Investigate health service use in the target population and compare to a clinical&#xD;
      sample admitted to outpatient treatment.&#xD;
&#xD;
      b) Investigate treatment experiences and health service collaborations in the target&#xD;
      population.&#xD;
&#xD;
      The project will provide rational for future preventive treatment interventions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: A cross-sectional investigation. The inclusion period will be one year.&#xD;
&#xD;
      The target group: Patients admitted to inpatient units (adult psychiatry, mental health&#xD;
      centres or hospitals) due to risk of severe self-harm. The duration of admissions are either&#xD;
      more than 4 weeks and/or patients have had more than five admissions in the preceding year.&#xD;
&#xD;
      The comparison group is a collaboration with the Norwegian Network of personality-focused&#xD;
      treatments and includes clinical data from 19 outpatient units within specialist mental&#xD;
      health services across Norway (baseline data for 300 patients admitted to treatment during&#xD;
      2017-2018).&#xD;
&#xD;
      Sample size: An inclusion of N=300 patients in the target Group and comparison group&#xD;
&#xD;
      Assessments: The assessment battery combines therapist administered interviews and patient&#xD;
      self-report measures to provide a broad differential-diagnostic evaluation and information&#xD;
      about treatment and health-service collaborations. It also includes therapist-reports.&#xD;
&#xD;
      Psychopathology: Assessment of psychiatric disorders includes interviews for symptom&#xD;
      disorders (MINI), personality traits and disorders (SCID-5-PD, and observer-evaluated global&#xD;
      functioning (GAF) administered in both the target and the comparison group. Assessment of the&#xD;
      target group will additionally include a screening interview on cognitive functioning (Hayes&#xD;
      Ability Screening Index, HASI, specific approval has been given), self-report screening of&#xD;
      autism (Ritvo Autisme Asperger Diagnoseskjema - Revidert RAADS-R), and a detailed interview&#xD;
      on psychosis (questions from MINI plus).&#xD;
&#xD;
      General, social and personality functioning: The assessment battery includes a combination of&#xD;
      well-established, (no cost) self-report measures covering overall functioning, symptoms,&#xD;
      trauma, personality functioning and maladaptive behaviors. These will be administered in both&#xD;
      the target and the comparison group. More details on assessment battery can be given on&#xD;
      request to PI.&#xD;
&#xD;
      Self-harming behaviors: Self-report on self-harming behaviors and suicide attempts last 6&#xD;
      months are included. Assessment of the target group will additionally include a more detailed&#xD;
      interview of self-harming behaviors adapted for Norwegian studies (Lifetime Para suicide&#xD;
      Count).&#xD;
&#xD;
      Service use, treatment experiences, and health service collaborations: Assessment of previous&#xD;
      treatments, age first time, and contact with child/adolescent psychiatry (self-report, both&#xD;
      the target and the comparison group), and a detailed interview on medication, treatments,&#xD;
      primary health care and welfare services last 6 months (specially designed interview, both&#xD;
      target and comparison group). In addition, for the target group, questions about involuntary&#xD;
      and restrictive regimes, treatment involvement, confidence, alliance and collaboration within&#xD;
      and across health services are included (patient and therapist reported).&#xD;
&#xD;
      Research collaborators:&#xD;
&#xD;
      The PhD candidate will follow the PhD educationary program at the University of Oslo. Main&#xD;
      supervisor is also Principle Investigator (E.H.Kvarstein), and co supervisor (G.Pedersen)&#xD;
      heads the Network collaboration. The PhD candidate will join the national project group and&#xD;
      be an associated member of the Research group for Personality Psychiatry.&#xD;
&#xD;
      The national project group is central in all phases; design, preparations, implementation&#xD;
      procedures, evaluation, and presentations of results. It covers all health regions, relevant&#xD;
      research environments, clinicians and users. It includes: Middle HR: T.Torgersen, PhD,&#xD;
      Western HR: T.Tveit, MD. Southeastern HR: P.A.Ringen, PhD, P.Danielsen, MA, C.A.Sveen (MA),&#xD;
      Tore Buer (MD). Northern HR: H.Tvete, MD, T.Høifødt, PhD. National Centre, Suicide Research&#xD;
      and Prevention: F.Walby,MA, R.K.Ramleth, MD (BUP). Regional Centre, Violence and Traumatic&#xD;
      Stress: I.Lunde, MA. Early intervention Psychosis: K.L.Romm, PhD. Personality Psychiatry&#xD;
      National Advisory Unit: Ø.Urnes,MD. User experience: T.Røstbakken, M.Pettersen, A.Holst.&#xD;
&#xD;
      The Research group for personality psychiatry (University of Oslo/Oslo University Hospital)&#xD;
      is an active, well-established research group with engagement in national and international&#xD;
      research collaborations specializing on personality pathology and clinical research.&#xD;
&#xD;
      The principle investigator (PI) and main supervisor of this project, E.H.Kvarstein, associate&#xD;
      professor, University of Oslo/ Head senior consultant, Section for Personality Psychiatry,&#xD;
      Oslo University Hospital, is head of the Research group of personality psychiatry.&#xD;
&#xD;
      The Norwegian Network for personality-focused treatment is a well-established collaboration&#xD;
      aiming to ensure clinical quality, systematic treatment evaluation and generate data for&#xD;
      clinical research (anonymous data collection). The Network was established in 1993 and&#xD;
      currently includes 19 outpatient treatment teams across Norway for patients with personality&#xD;
      disorder. Approximately 400 patients are admitted to treatments within the Network each year&#xD;
      (mean treatment duration: 2 years). The Network provides systems for patient assessment and&#xD;
      progress evaluation, systematic feedback reports on clinical outcomes and&#xD;
      supervision/seminars on diagnostic assessment and treatment. The main (ongoing) research&#xD;
      project in the Network is a multi-centre feasibility investigation of evidence-based&#xD;
      treatment for personality disorder (started in 2017) aiming to include longitudinal treatment&#xD;
      data for 500 patients.&#xD;
&#xD;
      &quot;Extreme challenges&quot; is a research collaboration between the national project group and the&#xD;
      Network. Baseline data from the multi-centre project constitute the outpatient comparison&#xD;
      group in &quot;Extreme challenges&quot; (300 patients, admitted to outpatient treatment in 2017-18,&#xD;
      data available in 2020).&#xD;
&#xD;
      Cosupervisor in the PhD project, head of the Network, is senior researcher Geir Pedersen. He&#xD;
      is affiliated within the Section for Personality Psychiatry, Oslo University Hospital and the&#xD;
      University of Oslo. He is a member of the research group.&#xD;
&#xD;
      Norwegian National Advisory Unit on Personality Psychiatry (NAPP) is the initiator of the&#xD;
      current project and the organizer of the national project group. With the establishment of an&#xD;
      expert user panel (recruiting users from the whole country), NAPP has also had an active role&#xD;
      establishing user engagement in this project.&#xD;
&#xD;
      Plan for activities - practical implementation of the cross sectional investigation: The&#xD;
      national project group has already completed a preliminary screening investigation, first&#xD;
      publication, and designed the current project. The project group is currently preparing&#xD;
      practical implementation of the project (mobilizing regional collaborators, local resource&#xD;
      groups and finalizing ethic approvals and systems for data collection).&#xD;
&#xD;
      2018/19: Preparation: Regional preparatory seminars for local clinicians and all&#xD;
      collaborators are scheduled to autumn 2019.&#xD;
&#xD;
      2019/2020: Data collection: Assessments of the target population will be performed at the&#xD;
      inpatient institutions by local clinicians qualified for diagnostic procedures. During the&#xD;
      data collection possibilities for feedbacks/clinical discussion of individual cases will be&#xD;
      offered.&#xD;
&#xD;
      Assessments in the comparison group involve measures already implemented (from June 2017).&#xD;
&#xD;
      2021: Dataanalysis, discussion and presentation of results: Datacollection will be concluded&#xD;
      and analyses of results proceeds.&#xD;
&#xD;
      2022: Project conclusion&#xD;
&#xD;
      Plan for dissemination of results:&#xD;
&#xD;
      Running information about the project with Norwegian summaries, key researchers and&#xD;
      references to all publications will be available at the internet home site of the Research&#xD;
      group for Personality Psychiatry in all phases of the project.&#xD;
&#xD;
      Three research publications are scheduled. Manuscripts will be submitted to international&#xD;
      peer reviewed journals (open access publication). Research results will also be presented in&#xD;
      relevant international/national conferences&#xD;
&#xD;
      When the project is concluded, the project group will arrange a conference for participating&#xD;
      clinicians/institutions/organizations, evaluating the investigation, implications and further&#xD;
      developments.&#xD;
&#xD;
      User involvement:&#xD;
&#xD;
      The project-group includes three members with relevant user experience, Thea Røstbakken, Mona&#xD;
      Pettersen and Andrea Holst.&#xD;
&#xD;
      Ethical considerations The regional ethical committee (REC) has approved the investigator's&#xD;
      application for ethical approval. REC reference number is: 2018/1124 A (REC South East).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Psychiatric Disorders as assessed by M.I.N.I.plus</measure>
    <time_frame>2019-2021</time_frame>
    <description>Diagnoses will be assessed by use of semistructured clinical interview: Mini International Neuropsychiatric Interview (M.I.N.I plus)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post Traumatic Stress Disorder as assessed by PTSD CL 5</measure>
    <time_frame>2019-2021</time_frame>
    <description>Presence and severity of PTSD symptoms will be assessed by PTSD Checklist for DSM-5 (PTSD CL 5)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of psychiatric symptoms as assessed by PHQ</measure>
    <time_frame>2019-2021</time_frame>
    <description>Severity of symptoms will be assessed by patient-reports based on the Patient Health Questionairre (PHQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Screening for substance use disorder as assessed by AUDIT/DUDIT</measure>
    <time_frame>2019-2021</time_frame>
    <description>Additional screening for substance abuse by self-report Alcohol/Drug use disorder identification test (AUDIT/DUDIT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Personality Disorders as assessed by SCID 5 PD</measure>
    <time_frame>2019-2021</time_frame>
    <description>Diagnoses will be assessed by use of the Structured Clinical interview for Diagnoses of Personality Disorders according to DSM-5: SCID-5-PD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychosocial functioning I as assessed by GAF</measure>
    <time_frame>2019-2021</time_frame>
    <description>Global functioning will be assessed by use of the observer-rated Global assessment of functioning (GAF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychosocial functioning II as assessed by WSAS</measure>
    <time_frame>2019-2021</time_frame>
    <description>Global functioning will be assessed by use of self-report: WOrk and Social adjustment Scale (WSAS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Learning disability screening as assessed by HASI</measure>
    <time_frame>2019-2021</time_frame>
    <description>Learning disability will be assessed by use of Hayes Ability Screening Index (HASI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Autism spectrum screening as assessed by RAADS-R</measure>
    <time_frame>2019-2021</time_frame>
    <description>Screening for autism will entail use of The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall personality functioning as assessed by SIPP-118</measure>
    <time_frame>2019-2021</time_frame>
    <description>Assessment of personality functioning entails use of the Severity Indices for Personality Functioning (SIPP-118)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional regulation as assessed by DERS</measure>
    <time_frame>2019-2021</time_frame>
    <description>Assessment of problems with emotional dysregulation entails use of Difficulties in emotional regulation scale (DERS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aggressive behaviors as assessed by MOAS</measure>
    <time_frame>2019-2021</time_frame>
    <description>Assessment of problems with aggressive outbursts or behaviors will be assessed by Items from the Modified Overt Aggression Scale (MOAS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alexithymia as assessed by TAS-20</measure>
    <time_frame>2019-2021</time_frame>
    <description>Assessment of aspects of affect consciousness will be assessed by the Toronto Alexithymia scale (TAS-20)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Close relationships and attachment patterns as assessed by ECR</measure>
    <time_frame>2019-2021</time_frame>
    <description>Assessment of capacities and maladaptive patterns in close relationships will be assessed by the inventory: Experiences in close relationships (ECR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Selfharming behaviors as assessed by LPC</measure>
    <time_frame>2019-2021</time_frame>
    <description>Detailed assessment of selfharming behaviors will entail use of the interview: Lifetime Para suicide Count (LPC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specialist mental health service utilization I as assessed by specific interview</measure>
    <time_frame>2019-2021</time_frame>
    <description>Interview designed for this project for systematic assessment of the volume of service use last six months (number of outpatient consultations).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specialist mental health service utilization II as assessed by specific interview</measure>
    <time_frame>2019-2021</time_frame>
    <description>Interview designed for this project for systematic assessment of the volume of service use last six months (number of inpatient (hospital) admissions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specialist mental health service utilization III as assessed by specific interview</measure>
    <time_frame>2019-2021</time_frame>
    <description>Interview designed for this project for systematic assessment of the volume of service use last six months (number of inpatient days in hospital).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specialist mental health service treatment as assessed by specific interview</measure>
    <time_frame>2019-2021</time_frame>
    <description>Interview designed for this project for systematic assessment of type of treatment (category) received last six months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Welfare services as assessed by specific interview</measure>
    <time_frame>2019-2021</time_frame>
    <description>Interview designed for this project for systematic assessment of type of welfare service (category) last six months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Age at first contact with specialist mental health services as assessed by specific interview</measure>
    <time_frame>2019-2021</time_frame>
    <description>Age (years) at first contact with mental health services</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Self Harm</condition>
  <condition>Personality Disorders</condition>
  <condition>Psychosis</condition>
  <condition>Developmental Disorder</condition>
  <condition>PTSD</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Inpatient cohort (Target group)</arm_group_label>
    <description>Inpatient at mental health centre/ psychiatric hospital due to severe self-harm. Duration &gt; 4 weeks and/or &gt; five admissions last year.&#xD;
Assessment of diagnoses, functioning and health services</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outpatient comparison cohort</arm_group_label>
    <description>Admitted to treatment within Norwegian Network of personality-focused treatment during 2017-2018.&#xD;
Assessment of diagnoses, functioning and health services</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of diagnoses, functioning and health services</intervention_name>
    <description>Systematic differential diagnostics, assessment of psychosocial and personality functioning and treatment/ health services</description>
    <arm_group_label>Inpatient cohort (Target group)</arm_group_label>
    <arm_group_label>Outpatient comparison cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The target population is patients with extensive hospitalization due to selfharming&#xD;
        behaviors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria Target population:&#xD;
&#xD;
          -  Admitted to inpatient units (adult psychiatry, mental health centres or hospitals) due&#xD;
             to risk of severe self-harm.&#xD;
&#xD;
          -  Duration of admissions either &gt; 4 weeks and/or &gt; five admissions preceding year.&#xD;
&#xD;
        Exclusion Criteria Target population:&#xD;
&#xD;
        • Not inpatients at a psychiatric, adult (18-60 yrs) institution&#xD;
&#xD;
        Inclusion Criteria comparison population:&#xD;
&#xD;
        • Assessed for outpatient treatment within the outpatient Network&#xD;
&#xD;
        Exclusion criteria comparison population:&#xD;
&#xD;
        • Assessed but not admitted to outpatient treatment within the Network&#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>Elfrida H Kvarstein, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elfrida H Kvarstein, MD,PhD</last_name>
    <phone>+47 91 10 91 59</phone>
    <email>e.h.kvarstein@medisin.uio.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Geir AF Pedersen, MA,PhD</last_name>
    <email>geir.pedersen@medisin.uio.no</email>
  </overall_contact_backup>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Elfrida H Kvarstein</investigator_full_name>
    <investigator_title>Head senior consultant/Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Selfharming behaviors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Self-Injurious Behavior</mesh_term>
    <mesh_term>Developmental Disabilities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03768674/Prot_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/NCT03768674
org study id: 2019/FO244009
secondary id: 2018/1124
nct id: NCT03768674
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients who self-harm are a heterogeneous population. Outpatient treatments structured for
      borderline personality disorder are often recommended and hospitalization kept to a minimum.
      However, few studies have focused on the most severe, complex conditions with extreme suicide
      risk. A recent national investigation from Norway (2017) demonstrated a far larger cohort of
      extensively hospitalized inpatients with extreme self-harming behaviors than was expected
      (N=427) - identified in all health regions. Reported challenges were high-risk situations,
      severe medical sequelae, difficult collaborations across services, and uncertainty about
      psychiatric diagnoses.

      Severe, often bizarre, self-harm is thus a major challenge for both patients and health
      services. In hospitals, safety measures can involve restrictions and involuntary regimes. As
      research on this target population is sparse, the current project seeks further understanding
      of complex conditions - psychopathology, treatment experiences and service collaboration.

      The project is a national, multi-center cooperation including patients in psychiatric
      hospitals in all health regions. It is cross sectional. Data is based on diagnostic
      interviews, patients' self-reported symptoms and both patients and service providers
      treatment experiences. The inclusion period for inpatients (N=300) and a comparison sample of
      outpatients (N=300) is one year.

      The target group is inpatients with extreme hospitalization and severe self-mutilation. A
      comparison group is patients with personality pathology attending outpatient treatments.
      Recruitment is across health regions.

      Aim 1: Investigate psychopathology of patients in the target population and compare to a
      clinical sample admitted to outpatient treatment

      Aim 2: Investigate personality functioning in the target population and compare to a clinical
      sample admitted to outpatient treatment

      Aim 3: a) Investigate health service use in the target population and compare to a clinical
      sample admitted to outpatient treatment.

      b) Investigate treatment experiences and health service collaborations in the target
      population.

      The project will provide rational for future preventive treatment interventions
Design: A cross-sectional investigation. The inclusion period will be one year.

      The target group: Patients admitted to inpatient units (adult psychiatry, mental health
      centres or hospitals) due to risk of severe self-harm. The duration of admissions are either
      more than 4 weeks and/or patients have had more than five admissions in the preceding year.

      The comparison group is a collaboration with the Norwegian Network of personality-focused
      treatments and includes clinical data from 19 outpatient units within specialist mental
      health services across Norway (baseline data for 300 patients admitted to treatment during
      2017-2018).

      Sample size: An inclusion of N=300 patients in the target Group and comparison group

      Assessments: The assessment battery combines therapist administered interviews and patient
      self-report measures to provide a broad differential-diagnostic evaluation and information
      about treatment and health-service collaborations. It also includes therapist-reports.

      Psychopathology: Assessment of psychiatric disorders includes interviews for symptom
      disorders (MINI), personality traits and disorders (SCID-5-PD, and observer-evaluated global
      functioning (GAF) administered in both the target and the comparison group. Assessment of the
      target group will additionally include a screening interview on cognitive functioning (Hayes
      Ability Screening Index, HASI, specific approval has been given), self-report screening of
      autism (Ritvo Autisme Asperger Diagnoseskjema - Revidert RAADS-R), and a detailed interview
      on psychosis (questions from MINI plus).

      General, social and personality functioning: The assessment battery includes a combination of
      well-established, (no cost) self-report measures covering overall functioning, symptoms,
      trauma, personality functioning and maladaptive behaviors. These will be administered in both
      the target and the comparison group. More details on assessment battery can be given on
      request to PI.

      Self-harming behaviors: Self-report on self-harming behaviors and suicide attempts last 6
      months are included. Assessment of the target group will additionally include a more detailed
      interview of self-harming behaviors adapted for Norwegian studies (Lifetime Para suicide
      Count).

      Service use, treatment experiences, and health service collaborations: Assessment of previous
      treatments, age first time, and contact with child/adolescent psychiatry (self-report, both
      the target and the comparison group), and a detailed interview on medication, treatments,
      primary health care and welfare services last 6 months (specially designed interview, both
      target and comparison group). In addition, for the target group, questions about involuntary
      and restrictive regimes, treatment involvement, confidence, alliance and collaboration within
      and across health services are included (patient and therapist reported).

      Research collaborators:

      The PhD candidate will follow the PhD educationary program at the University of Oslo. Main
      supervisor is also Principle Investigator (E.H.Kvarstein), and co supervisor (G.Pedersen)
      heads the Network collaboration. The PhD candidate will join the national project group and
      be an associated member of the Research group for Personality Psychiatry.

      The national project group is central in all phases; design, preparations, implementation
      procedures, evaluation, and presentations of results. It covers all health regions, relevant
      research environments, clinicians and users. It includes: Middle HR: T.Torgersen, PhD,
      Western HR: T.Tveit, MD. Southeastern HR: P.A.Ringen, PhD, P.Danielsen, MA, C.A.Sveen (MA),
      Tore Buer (MD). Northern HR: H.Tvete, MD, T.Høifødt, PhD. National Centre, Suicide Research
      and Prevention: F.Walby,MA, R.K.Ramleth, MD (BUP). Regional Centre, Violence and Traumatic
      Stress: I.Lunde, MA. Early intervention Psychosis: K.L.Romm, PhD. Personality Psychiatry
      National Advisory Unit: Ø.Urnes,MD. User experience: T.Røstbakken, M.Pettersen, A.Holst.

      The Research group for personality psychiatry (University of Oslo/Oslo University Hospital)
      is an active, well-established research group with engagement in national and international
      research collaborations specializing on personality pathology and clinical research.

      The principle investigator (PI) and main supervisor of this project, E.H.Kvarstein, associate
      professor, University of Oslo/ Head senior consultant, Section for Personality Psychiatry,
      Oslo University Hospital, is head of the Research group of personality psychiatry.

      The Norwegian Network for personality-focused treatment is a well-established collaboration
      aiming to ensure clinical quality, systematic treatment evaluation and generate data for
      clinical research (anonymous data collection). The Network was established in 1993 and
      currently includes 19 outpatient treatment teams across Norway for patients with personality
      disorder. Approximately 400 patients are admitted to treatments within the Network each year
      (mean treatment duration: 2 years). The Network provides systems for patient assessment and
      progress evaluation, systematic feedback reports on clinical outcomes and
      supervision/seminars on diagnostic assessment and treatment. The main (ongoing) research
      project in the Network is a multi-centre feasibility investigation of evidence-based
      treatment for personality disorder (started in 2017) aiming to include longitudinal treatment
      data for 500 patients.

      "Extreme challenges" is a research collaboration between the national project group and the
      Network. Baseline data from the multi-centre project constitute the outpatient comparison
      group in "Extreme challenges" (300 patients, admitted to outpatient treatment in 2017-18,
      data available in 2020).

      Cosupervisor in the PhD project, head of the Network, is senior researcher Geir Pedersen. He
      is affiliated within the Section for Personality Psychiatry, Oslo University Hospital and the
      University of Oslo. He is a member of the research group.

      Norwegian National Advisory Unit on Personality Psychiatry (NAPP) is the initiator of the
      current project and the organizer of the national project group. With the establishment of an
      expert user panel (recruiting users from the whole country), NAPP has also had an active role
      establishing user engagement in this project.

      Plan for activities - practical implementation of the cross sectional investigation: The
      national project group has already completed a preliminary screening investigation, first
      publication, and designed the current project. The project group is currently preparing
      practical implementation of the project (mobilizing regional collaborators, local resource
      groups and finalizing ethic approvals and systems for data collection).

      2018/19: Preparation: Regional preparatory seminars for local clinicians and all
      collaborators are scheduled to autumn 2019.

      2019/2020: Data collection: Assessments of the target population will be performed at the
      inpatient institutions by local clinicians qualified for diagnostic procedures. During the
      data collection possibilities for feedbacks/clinical discussion of individual cases will be
      offered.

      Assessments in the comparison group involve measures already implemented (from June 2017).

      2021: Dataanalysis, discussion and presentation of results: Datacollection will be concluded
      and analyses of results proceeds.

      2022: Project conclusion

      Plan for dissemination of results:

      Running information about the project with Norwegian summaries, key researchers and
      references to all publications will be available at the internet home site of the Research
      group for Personality Psychiatry in all phases of the project.

      Three research publications are scheduled. Manuscripts will be submitted to international
      peer reviewed journals (open access publication). Research results will also be presented in
      relevant international/national conferences

      When the project is concluded, the project group will arrange a conference for participating
      clinicians/institutions/organizations, evaluating the investigation, implications and further
      developments.

      User involvement:

      The project-group includes three members with relevant user experience, Thea Røstbakken, Mona
      Pettersen and Andrea Holst.

      Ethical considerations The regional ethical committee (REC) has approved the investigator's
      application for ethical approval. REC reference number is: 2018/1124 A (REC South East).
observational model: Cohort
time perspective: Cross-Sectional
measure: Psychiatric Disorders as assessed by M.I.N.I.plus
time frame: 2019-2021
description: Diagnoses will be assessed by use of semistructured clinical interview: Mini International Neuropsychiatric Interview (M.I.N.I plus)
measure: Post Traumatic Stress Disorder as assessed by PTSD CL 5
time frame: 2019-2021
description: Presence and severity of PTSD symptoms will be assessed by PTSD Checklist for DSM-5 (PTSD CL 5)
measure: Severity of psychiatric symptoms as assessed by PHQ
time frame: 2019-2021
description: Severity of symptoms will be assessed by patient-reports based on the Patient Health Questionairre (PHQ)
measure: Screening for substance use disorder as assessed by AUDIT/DUDIT
time frame: 2019-2021
description: Additional screening for substance abuse by self-report Alcohol/Drug use disorder identification test (AUDIT/DUDIT)
measure: Personality Disorders as assessed by SCID 5 PD
time frame: 2019-2021
description: Diagnoses will be assessed by use of the Structured Clinical interview for Diagnoses of Personality Disorders according to DSM-5: SCID-5-PD
measure: Psychosocial functioning I as assessed by GAF
time frame: 2019-2021
description: Global functioning will be assessed by use of the observer-rated Global assessment of functioning (GAF)
measure: Psychosocial functioning II as assessed by WSAS
time frame: 2019-2021
description: Global functioning will be assessed by use of self-report: WOrk and Social adjustment Scale (WSAS)
measure: Learning disability screening as assessed by HASI
time frame: 2019-2021
description: Learning disability will be assessed by use of Hayes Ability Screening Index (HASI)
measure: Autism spectrum screening as assessed by RAADS-R
time frame: 2019-2021
description: Screening for autism will entail use of The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R)
measure: Overall personality functioning as assessed by SIPP-118
time frame: 2019-2021
description: Assessment of personality functioning entails use of the Severity Indices for Personality Functioning (SIPP-118)
measure: Emotional regulation as assessed by DERS
time frame: 2019-2021
description: Assessment of problems with emotional dysregulation entails use of Difficulties in emotional regulation scale (DERS)
measure: Aggressive behaviors as assessed by MOAS
time frame: 2019-2021
description: Assessment of problems with aggressive outbursts or behaviors will be assessed by Items from the Modified Overt Aggression Scale (MOAS)
measure: Alexithymia as assessed by TAS-20
time frame: 2019-2021
description: Assessment of aspects of affect consciousness will be assessed by the Toronto Alexithymia scale (TAS-20)
measure: Close relationships and attachment patterns as assessed by ECR
time frame: 2019-2021
description: Assessment of capacities and maladaptive patterns in close relationships will be assessed by the inventory: Experiences in close relationships (ECR).
measure: Selfharming behaviors as assessed by LPC
time frame: 2019-2021
description: Detailed assessment of selfharming behaviors will entail use of the interview: Lifetime Para suicide Count (LPC)
measure: Specialist mental health service utilization I as assessed by specific interview
time frame: 2019-2021
description: Interview designed for this project for systematic assessment of the volume of service use last six months (number of outpatient consultations).
measure: Specialist mental health service utilization II as assessed by specific interview
time frame: 2019-2021
description: Interview designed for this project for systematic assessment of the volume of service use last six months (number of inpatient (hospital) admissions).
measure: Specialist mental health service utilization III as assessed by specific interview
time frame: 2019-2021
description: Interview designed for this project for systematic assessment of the volume of service use last six months (number of inpatient days in hospital).
measure: Specialist mental health service treatment as assessed by specific interview
time frame: 2019-2021
description: Interview designed for this project for systematic assessment of type of treatment (category) received last six months.
measure: Welfare services as assessed by specific interview
time frame: 2019-2021
description: Interview designed for this project for systematic assessment of type of welfare service (category) last six months.
measure: Age at first contact with specialist mental health services as assessed by specific interview
time frame: 2019-2021
description: Age (years) at first contact with mental health services
arm group label: Inpatient cohort (Target group)
description: Inpatient at mental health centre/ psychiatric hospital due to severe self-harm. Duration > 4 weeks and/or > five admissions last year.
Assessment of diagnoses, functioning and health services
arm group label: Outpatient comparison cohort
description: Admitted to treatment within Norwegian Network of personality-focused treatment during 2017-2018.
Assessment of diagnoses, functioning and health services
intervention type: Other
intervention name: Assessment of diagnoses, functioning and health services
description: Systematic differential diagnostics, assessment of psychosocial and personality functioning and treatment/ health services
arm group label: Inpatient cohort (Target group)
arm group label: Outpatient comparison cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Elfrida H Kvarstein, MD,PhD
role: Principal Investigator
affiliation: Oslo University Hospital
last name: Elfrida H Kvarstein, MD,PhD
phone: +47 91 10 91 59
email: e.h.kvarstein@medisin.uio.no
last name: Geir AF Pedersen, MA,PhD
email: geir.pedersen@medisin.uio.no
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Elfrida H Kvarstein
investigator title: Head senior consultant/Associate Professor
mesh term: Personality Disorders
mesh term: Self-Injurious Behavior
mesh term: Developmental Disabilities
sharing ipd: No
provided document: 