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Extreme Challenges - Psychopathology & Treatment Experiences Among Severly Selfharming Inpatients in Norway

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ClinicalTrials.gov Identifier: NCT03768674
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Extrastiftelsen
National Advisory Unit for Personality Psychiatry (NAPP)
Research Group Personality Psychiatry
Network for personality-focused treatment
National Centre for Suicide Research and Prevention (NSSF)
Regional Centre for Violence and Traumatic Stress (RVTS)
Regional Centre for Early Intervention Psychosis (TIPS SØrØst)
Regional collaborators and users
Information provided by (Responsible Party):
Elfrida H Kvarstein, Oslo University Hospital

Brief Summary:

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


Condition or disease Intervention/treatment
Self Harm Personality Disorders Psychosis Developmental Disorder PTSD Cognitive Impairment Other: Assessment of diagnoses, functioning and health services

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: English Title: Extreme Challenges - Psychopathology, Treatment Organization and Experiences Among Psychiatric Inpatients With Severe Self-harming Behavior in Norway
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2022

Group/Cohort Intervention/treatment
Inpatient cohort (Target group)

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

Other: Assessment of diagnoses, functioning and health services
Systematic differential diagnostics, assessment of psychosocial and personality functioning and treatment/ health services

Outpatient comparison cohort

Admitted to treatment within Norwegian Network of personality-focused treatment during 2017-2018.

Assessment of diagnoses, functioning and health services

Other: Assessment of diagnoses, functioning and health services
Systematic differential diagnostics, assessment of psychosocial and personality functioning and treatment/ health services




Primary Outcome Measures :
  1. Psychiatric Disorders as assessed by M.I.N.I.plus [ Time Frame: 2019-2021 ]
    Diagnoses will be assessed by use of semistructured clinical interview: Mini International Neuropsychiatric Interview (M.I.N.I plus)

  2. Post Traumatic Stress Disorder as assessed by PTSD CL 5 [ Time Frame: 2019-2021 ]
    Presence and severity of PTSD symptoms will be assessed by PTSD Checklist for DSM-5 (PTSD CL 5)

  3. Severity of psychiatric symptoms as assessed by PHQ [ Time Frame: 2019-2021 ]
    Severity of symptoms will be assessed by patient-reports based on the Patient Health Questionairre (PHQ)

  4. Screening for substance use disorder as assessed by AUDIT/DUDIT [ Time Frame: 2019-2021 ]
    Additional screening for substance abuse by self-report Alcohol/Drug use disorder identification test (AUDIT/DUDIT)

  5. Personality Disorders as assessed by SCID 5 PD [ Time Frame: 2019-2021 ]
    Diagnoses will be assessed by use of the Structured Clinical interview for Diagnoses of Personality Disorders according to DSM-5: SCID-5-PD

  6. Psychosocial functioning I as assessed by GAF [ Time Frame: 2019-2021 ]
    Global functioning will be assessed by use of the observer-rated Global assessment of functioning (GAF)

  7. Psychosocial functioning II as assessed by WSAS [ Time Frame: 2019-2021 ]
    Global functioning will be assessed by use of self-report: WOrk and Social adjustment Scale (WSAS)

  8. Learning disability screening as assessed by HASI [ Time Frame: 2019-2021 ]
    Learning disability will be assessed by use of Hayes Ability Screening Index (HASI)

  9. Autism spectrum screening as assessed by RAADS-R [ Time Frame: 2019-2021 ]
    Screening for autism will entail use of The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R)

  10. Overall personality functioning as assessed by SIPP-118 [ Time Frame: 2019-2021 ]
    Assessment of personality functioning entails use of the Severity Indices for Personality Functioning (SIPP-118)

  11. Emotional regulation as assessed by DERS [ Time Frame: 2019-2021 ]
    Assessment of problems with emotional dysregulation entails use of Difficulties in emotional regulation scale (DERS)

  12. Aggressive behaviors as assessed by MOAS [ Time Frame: 2019-2021 ]
    Assessment of problems with aggressive outbursts or behaviors will be assessed by Items from the Modified Overt Aggression Scale (MOAS)

  13. Alexithymia as assessed by TAS-20 [ Time Frame: 2019-2021 ]
    Assessment of aspects of affect consciousness will be assessed by the Toronto Alexithymia scale (TAS-20)

  14. Close relationships and attachment patterns as assessed by ECR [ Time Frame: 2019-2021 ]
    Assessment of capacities and maladaptive patterns in close relationships will be assessed by the inventory: Experiences in close relationships (ECR).

  15. Selfharming behaviors as assessed by LPC [ Time Frame: 2019-2021 ]
    Detailed assessment of selfharming behaviors will entail use of the interview: Lifetime Para suicide Count (LPC)

  16. Specialist mental health service utilization I as assessed by specific interview [ Time Frame: 2019-2021 ]
    Interview designed for this project for systematic assessment of the volume of service use last six months (number of outpatient consultations).

  17. Specialist mental health service utilization II as assessed by specific interview [ Time Frame: 2019-2021 ]
    Interview designed for this project for systematic assessment of the volume of service use last six months (number of inpatient (hospital) admissions).

  18. Specialist mental health service utilization III as assessed by specific interview [ Time Frame: 2019-2021 ]
    Interview designed for this project for systematic assessment of the volume of service use last six months (number of inpatient days in hospital).

  19. Specialist mental health service treatment as assessed by specific interview [ Time Frame: 2019-2021 ]
    Interview designed for this project for systematic assessment of type of treatment (category) received last six months.

  20. Welfare services as assessed by specific interview [ Time Frame: 2019-2021 ]
    Interview designed for this project for systematic assessment of type of welfare service (category) last six months.

  21. Age at first contact with specialist mental health services as assessed by specific interview [ Time Frame: 2019-2021 ]
    Age (years) at first contact with mental health services



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The target population is patients with extensive hospitalization due to selfharming behaviors
Criteria

Inclusion Criteria Target population:

  • Admitted to inpatient units (adult psychiatry, mental health centres or hospitals) due to risk of severe self-harm.
  • Duration of admissions either > 4 weeks and/or > five admissions preceding year.

Exclusion Criteria Target population:

• Not inpatients at a psychiatric, adult (18-60 yrs) institution

Inclusion Criteria comparison population:

• Assessed for outpatient treatment within the outpatient Network

Exclusion criteria comparison population:

• Assessed but not admitted to outpatient treatment within the Network


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): NCT03768674


Contacts
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Contact: Elfrida H Kvarstein, MD,PhD +47 91 10 91 59 e.h.kvarstein@medisin.uio.no
Contact: Geir AF Pedersen, MA,PhD geir.pedersen@medisin.uio.no

Sponsors and Collaborators
Oslo University Hospital
Extrastiftelsen
National Advisory Unit for Personality Psychiatry (NAPP)
Research Group Personality Psychiatry
Network for personality-focused treatment
National Centre for Suicide Research and Prevention (NSSF)
Regional Centre for Violence and Traumatic Stress (RVTS)
Regional Centre for Early Intervention Psychosis (TIPS SØrØst)
Regional collaborators and users
Investigators
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Principal Investigator: Elfrida H Kvarstein, MD,PhD Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Elfrida H Kvarstein, Oslo University Hospital:
Study Protocol  [PDF] November 23, 2018


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Responsible Party: Elfrida H Kvarstein, Head senior consultant/Associate Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03768674     History of Changes
Other Study ID Numbers: 2019/FO244009
2018/1124 ( Other Identifier: Regional Ethics Committee )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elfrida H Kvarstein, Oslo University Hospital:
Selfharming behaviors

Additional relevant MeSH terms:
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Disease
Cognitive Dysfunction
Personality Disorders
Developmental Disabilities
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurodevelopmental Disorders