NCT07162909

Brief Summary

The overarching aim of the research project is to identify risk patterns preceding criminal acts among individuals later subject to forensic psychiatric evaluation (FPE) in Sweden, including factors within psychiatric care as well as broader individual or contextual factors. Although individuals who undergo an FPE represent a small subset of all individuals who commit criminal acts, the implications of being sentenced to forensic psychiatric care are profound. In Sweden, approximately 300 individuals are transferred to forensic psychiatric care each year, with a median duration of 7.5 years. Notably, the number of admissions exceeds the number of discharges annually, resulting in a growing forensic psychiatric population. This increasing trend underscores the need for increased knowledge and preventive efforts. All forensic psychiatric patients undergo an FPE before the sentencing, and previous studies show that most of these individuals were already known to the psychiatric system prior to the offenses, which means that individuals in these groups are overlapping. However, the mean length of stay in psychiatric inpatient compulsory care is much shorter than that in forensic psychiatric care. Clinical expertise from FPEs suggests that identifiable risk patterns may exist before the criminal offence. The question of whether such potential risk patterns exist within this patient group has not been systematically studied before, which is why the current study aims to investigate this issue. Can risk patterns be identified within psychiatric care prior to the offense? If risk patterns can be identified, knowledge of such risk patterns could hopefully increase risk awareness within psychiatric services and lead to more frequent and accurate violence risk assessments. Knowledge of such risk patterns could also serve as a foundation for preventive measures. The long-term goal is to reduce the likelihood that individuals receiving psychiatric care progress to becoming forensic psychiatric patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

June 23, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

June 23, 2025

Last Update Submit

August 17, 2026

Conditions

Keywords

severe mental disorderforensic psychiatric evaluationrisk patternsviolence

Outcome Measures

Primary Outcomes (1)

  • Risk markers

    26 predefined risk markers that will be searched for in the retrospective record review. All risk markers have their own specific definition. For detailed description, see attached document.

    All risk makers will be searched for in the three-month period before the date of the criminal act (case croup) and also in a three-month period for the control group.

Study Arms (2)

Cases

The study population consists of individuals aged ≥ 18 years who have had or currently have contact with a psychiatric care provider within Region Stockholm (public clinic or private provider with a regional agreement) whose medical records were requested by the National Board of Forensic Medicine (NBFM) in 2023 for forensic psychiatric evaluation (§ 7-evaluation or FPE), estimated to be n=250.

Controls

The control group consists of individuals aged ≥ 18 years who have had or currently have contact with a psychiatric care provider within Region Stockholm (public clinic or private provider with a regional agreement) whose medical records were not requested by the NBFM in 2023. The control group is matched to the study population based on gender, age and psychiatric care unit (psychiatric intensive care units, psychosis ward, general psychiatric ward, psychiatric outpatient clinic, psychiatric emergency unit). Thereby we hope that the control group will consist of individuals with similar psychiatric conditions and care burden as the study population.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Case group: individuals ≥ 18 years who had contact with at least one psychiatric care provider within Region Stockholm, Sweden. This included both clinics operated by a Swedish healthcare region and private clinics operating under regional agreements. Individuals eligible for the case group were those whose psychiatric medical records were requested by the Swedish National Board of Forensic Medicine (NBFM) in 2023 for the purpose of conducting a forensic psychiatric evaluation, either a preliminary assessment (§7 examination) or a full forensic psychiatric evaluation (FPE). Control group: Similar individuals, but whose psychiatric medical records were not requested by the NBFM in 2023 for the purpose of conducting a forensic psychiatric evaluation.

You may qualify if:

  • Age ≥ 18 years
  • Contact with a psychiatric care provider within Region Stockholm
  • Medical records requested by the NBFM in 2023 for forensic psychiatric evaluation
  • Age ≥ 18 years
  • Contact with a psychiatric care provider within Region Stockholm
  • Medical records NOT requested by the NBFM in 2023 for forensic psychiatric evaluation
  • Matching criteria:
  • Gender (male/female)
  • Age group (18-24, 24-39 and \>39 years)
  • Psychiatric care unit

You may not qualify if:

  • No registered psychiatric care contact in Region Stockholm's shared electronic medical record system, three months prior to the date of the index offense.
  • The index offense before 2018.
  • Individual previously underwent an FPE at some point.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Katarina Howner, MD, PhD, ass prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 23, 2025

First Posted

September 9, 2025

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations