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临床试验/NCT03768674
NCT03768674已完成不适用

English Title: Extreme Challenges - Psychopathology, Treatment Organization and Experiences Among Psychiatric Inpatients With Severe Self-harming Behavior in Norway

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 1,640 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,640
试验地点
1
主要终点
Psychosocial functioning I as assessed by GAF

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Psychosocial functioning I as assessed by GAF

时间窗: 2019-2021

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

Autism spectrum screening as assessed by RAADS-R

时间窗: 2019-2021

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

Overall personality functioning as assessed by SIPP-118

时间窗: 2019-2021

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

Alexithymia as assessed by TAS-20

时间窗: 2019-2021

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

Specialist mental health service utilization III as assessed by specific interview

时间窗: 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).

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

时间窗: 2019-2021

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

Post Traumatic Stress Disorder as assessed by PTSD CL 5

时间窗: 2019-2021

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

Severity of psychiatric symptoms as assessed by PHQ

时间窗: 2019-2021

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

Screening for substance use disorder as assessed by AUDIT/DUDIT

时间窗: 2019-2021

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

Learning disability screening as assessed by HASI

时间窗: 2019-2021

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

Selfharming behaviors as assessed by LPC

时间窗: 2019-2021

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

Welfare services as assessed by specific interview

时间窗: 2019-2021

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

Personality Disorders as assessed by SCID 5 PD

时间窗: 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

Aggressive behaviors as assessed by MOAS

时间窗: 2019-2021

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

Specialist mental health service utilization II as assessed by specific interview

时间窗: 2019-2021

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

Close relationships and attachment patterns as assessed by ECR

时间窗: 2019-2021

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

Psychosocial functioning II as assessed by WSAS

时间窗: 2019-2021

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

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

时间窗: 2019-2021

Age (years) at first contact with mental health services

Specialist mental health service utilization I as assessed by specific interview

时间窗: 2019-2021

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

Emotional regulation as assessed by DERS

时间窗: 2019-2021

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

Specialist mental health service treatment as assessed by specific interview

时间窗: 2019-2021

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

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elfrida H Kvarstein

Head senior consultant/Associate Professor

Oslo University Hospital

研究点 (1)

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