Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03768674 |
| Other study ID # |
2019/FO244009 |
| Secondary ID |
2018/1124 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
September 1, 2021 |
Study information
| Verified date |
June 2024 |
| Source |
Oslo University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
Description:
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).
