NCT03768674

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,640

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

November 11, 2018

Last Update Submit

June 20, 2024

Conditions

Keywords

Selfharming behaviors

Outcome Measures

Primary Outcomes (21)

  • Psychiatric Disorders as assessed by M.I.N.I.plus

    Diagnoses will be assessed by use of semistructured clinical interview: Mini International Neuropsychiatric Interview (M.I.N.I plus)

    2019-2021

  • Post Traumatic Stress Disorder as assessed by PTSD CL 5

    Presence and severity of PTSD symptoms will be assessed by PTSD Checklist for DSM-5 (PTSD CL 5)

    2019-2021

  • Severity of psychiatric symptoms as assessed by PHQ

    Severity of symptoms will be assessed by patient-reports based on the Patient Health Questionairre (PHQ)

    2019-2021

  • Screening for substance use disorder as assessed by AUDIT/DUDIT

    Additional screening for substance abuse by self-report Alcohol/Drug use disorder identification test (AUDIT/DUDIT)

    2019-2021

  • Personality Disorders as assessed by SCID 5 PD

    Diagnoses will be assessed by use of the Structured Clinical interview for Diagnoses of Personality Disorders according to DSM-5: SCID-5-PD

    2019-2021

  • Psychosocial functioning I as assessed by GAF

    Global functioning will be assessed by use of the observer-rated Global assessment of functioning (GAF)

    2019-2021

  • Psychosocial functioning II as assessed by WSAS

    Global functioning will be assessed by use of self-report: WOrk and Social adjustment Scale (WSAS)

    2019-2021

  • Learning disability screening as assessed by HASI

    Learning disability will be assessed by use of Hayes Ability Screening Index (HASI)

    2019-2021

  • Autism spectrum screening as assessed by RAADS-R

    Screening for autism will entail use of The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R)

    2019-2021

  • Overall personality functioning as assessed by SIPP-118

    Assessment of personality functioning entails use of the Severity Indices for Personality Functioning (SIPP-118)

    2019-2021

  • Emotional regulation as assessed by DERS

    Assessment of problems with emotional dysregulation entails use of Difficulties in emotional regulation scale (DERS)

    2019-2021

  • Aggressive behaviors as assessed by MOAS

    Assessment of problems with aggressive outbursts or behaviors will be assessed by Items from the Modified Overt Aggression Scale (MOAS)

    2019-2021

  • Alexithymia as assessed by TAS-20

    Assessment of aspects of affect consciousness will be assessed by the Toronto Alexithymia scale (TAS-20)

    2019-2021

  • Close relationships and attachment patterns as assessed by ECR

    Assessment of capacities and maladaptive patterns in close relationships will be assessed by the inventory: Experiences in close relationships (ECR).

    2019-2021

  • Selfharming behaviors as assessed by LPC

    Detailed assessment of selfharming behaviors will entail use of the interview: Lifetime Para suicide Count (LPC)

    2019-2021

  • Specialist mental health service utilization I as assessed by specific interview

    Interview designed for this project for systematic assessment of the volume of service use last six months (number of outpatient consultations).

    2019-2021

  • Specialist mental health service utilization II as assessed by specific interview

    Interview designed for this project for systematic assessment of the volume of service use last six months (number of inpatient (hospital) admissions).

    2019-2021

  • Specialist mental health service utilization III as assessed by specific interview

    Interview designed for this project for systematic assessment of the volume of service use last six months (number of inpatient days in hospital).

    2019-2021

  • Specialist mental health service treatment as assessed by specific interview

    Interview designed for this project for systematic assessment of type of treatment (category) received last six months.

    2019-2021

  • Welfare services as assessed by specific interview

    Interview designed for this project for systematic assessment of type of welfare service (category) last six months.

    2019-2021

  • Age at first contact with specialist mental health services as assessed by specific interview

    Age (years) at first contact with mental health services

    2019-2021

Study Arms (2)

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

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

Interventions

Systematic differential diagnostics, assessment of psychosocial and personality functioning and treatment/ health services

Inpatient cohort (Target group)Outpatient comparison cohort

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The target population is patients with extensive hospitalization due to selfharming behaviors

You may qualify if:

  • 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.

You may not qualify if:

  • Not inpatients at a psychiatric, adult (18-60 yrs) institution
  • Assessed for outpatient treatment within the outpatient Network
  • Assessed but not admitted to outpatient treatment within the Network

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Self-Injurious BehaviorPersonality DisordersPsychotic DisordersDevelopmental DisabilitiesStress Disorders, Post-TraumaticCognitive Dysfunction

Interventions

Functional StatusHealth Services

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersNeurodevelopmental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Activities of Daily LivingRehabilitationHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Elfrida H Kvarstein, MD,PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head senior consultant/Associate Professor

Study Record Dates

First Submitted

November 11, 2018

First Posted

December 7, 2018

Study Start

October 1, 2019

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations