Cognitive Impairment Clinical Trial
Official title:
English Title: Extreme Challenges - Psychopathology, Treatment Organization and Experiences Among Psychiatric Inpatients With Severe Self-harming Behavior in Norway
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
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Extrastiftelsen, National Advisory Unit for Personality Psychiatry (NAPP), National Centre for Suicide Research and Prevention (NSSF), Network for personality-focused treatment, Regional Centre for Early Intervention Psychosis (TIPS SØrØst), Regional Centre for Violence and Traumatic Stress (RVTS), Regional collaborators and users, Research Group Personality Psychiatry |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Learning disability screening as assessed by HASI | Learning disability will be assessed by use of Hayes Ability Screening Index (HASI) | 2019-2021 | |
Primary | 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 | |
Primary | 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 | |
Primary | Emotional regulation as assessed by DERS | Assessment of problems with emotional dysregulation entails use of Difficulties in emotional regulation scale (DERS) | 2019-2021 | |
Primary | 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 | |
Primary | Alexithymia as assessed by TAS-20 | Assessment of aspects of affect consciousness will be assessed by the Toronto Alexithymia scale (TAS-20) | 2019-2021 | |
Primary | 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 | |
Primary | Selfharming behaviors as assessed by LPC | Detailed assessment of selfharming behaviors will entail use of the interview: Lifetime Para suicide Count (LPC) | 2019-2021 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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