NCT05932108

Brief Summary

The aim of this project is to evaluate the violence prevention method Therapeutic meeting with aggression (TERMA) regarding adverse events and perceived safety by patients and staff within forensic psychiatric inpatient care. Additionally, the project will investigate whether the organizational culture influences the implementation of the TERMA method and the experiences of patients and staff in situations involving threats, violence, and the use of coercive measures.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Status
unknown

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

June 15, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

July 11, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

June 15, 2023

Last Update Submit

July 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Perceived Safety Questionnaire (E13)

    Questionnaire data on perceived safety. E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.

    Change measure (baseline to 6 months)

  • Perceived Safety Questionnaire (E13)

    Questionnaire data on perceived safety. E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.

    Change measure (baseline to 1 year)

Secondary Outcomes (11)

  • Organisations Value Questionnaire (OVQ).

    Change measure (baseline to 6 months)

  • Organisations Value Questionnaire (OVQ).

    Change measure (baseline to 1 year)

  • Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)

    Baseline

  • Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)

    6 months

  • Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)

    1 year

  • +6 more secondary outcomes

Study Arms (2)

Staff

Educational intervention in TERMA. All staff are required to attend the education.

Behavioral: Education in TERMA

Patients

Patients will not attend any education in TERMA. Data will be collected before and after the staffs education to se if the patients think the attitude of the staff have changed.

Other: Changed work routines based on TERMA

Interventions

Education of staff in TERMA. The primary aim of TERMA is to prevent aggression and violence through a system of low-effective treatment that is divided into escalating levels based on the patient's aggression level, risk of violence, and acts of violence . The TERMA model focuses on treatment, communication, and management of compassionate healthcare in forensic psychiatric settings . The levels of the TERMA model are in a "cascading" order, whereby if the treatment and management of one level are ineffective, the next level is initiated, and so on. The primary level involves the daily behavior and health status of the patient. The secondary level involves risk assessment and violence management, with a focus on creating an understanding of the situation for both the patient and healthcare workers. The tertiary level is utilized when violence cannot be avoided . Each level corresponds to a specific response according to the demands of the situation and environment.

Staff

NO planned intervention but staff work routines and behavior may change after their education in TERMA. Patients are exposed to these changes.

Patients

Eligibility Criteria

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

Staff at a forensic psychiatry department. Patients at a forensic psychiatry departmen

You may qualify if:

  • ≥ 18 years of age who
  • work in forensic psychiatric inpatient care,
  • understand and speak Swedish or English, and are
  • willing to participate and sign a consent form.

You may not qualify if:

  • not willing to participate
  • ≥ 18 years of age who are
  • admitted to forensic psychiatric inpatient care according to the Swedish Forensic Psychiatric Care Act,
  • understand and speak Swedish or English,
  • have approval to participate from the treating physician, and are
  • willing to participate and sign a consent form.
  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Sara Wallström, PhD

    Västra Götalandsregionen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Wallström, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

July 6, 2023

Study Start

July 15, 2023

Primary Completion

February 25, 2024

Study Completion

September 25, 2024

Last Updated

July 11, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data (IPD)