NCT03989765

Brief Summary

There is considerable geographical variation in the rates of compulsion in psychiatric services within as well as between countries. Reducing the use of compulsion of patients with severe mental illness is an expressed policy aim, and also a demand from service user organisations. In Norway, municipalities hold responsibility for primary care and are therefore central to the delivery of services to people with severe mental illness. This indicates a potential for intervening at the municipal level to reduce the use of compulsion where it is high. The Reducing Coercion in Norway study (RECON) will, in collaboration with municipalities with high compulsion rates, develop a municipal-level intervention (Stage 1) that will be implemented in a cluster-RCT (Stage 2) to test if it has effect on compulsion rates.pulsion rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 6, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

June 25, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

3.3 years

First QC Date

June 6, 2019

Last Update Submit

June 4, 2024

Conditions

Compulsion

Outcome Measures

Primary Outcomes (2)

  • Change in prevalence rates of involuntary treatment episodes

    Change in prevalence rates of involuntary treatment episodes per 10K inhabitants over the age of 18. Involuntary treatment episodes will include both inpatient and outpatient episodes of compulsion

    12 months prior to and 12 months during the intervention

  • Change in prevalence rates of involuntary treatment episodes

    Change in prevalence rates of involuntary treatment episodes per 10K inhabitants over the age of 18. Involuntary treatment episodes will include both inpatient and outpatient episodes of compulsion

    12 months prior to and 12 months after the intervention period has ended

Secondary Outcomes (3)

  • Referral rates

    12 months prior to and 12 months during the intervention

  • Referral outcome

    12 months prior to and 12 months during the intervention

  • Duration of compulsion

    12 months prior to and 12 months during the intervention

Study Arms (2)

Intervention arm

EXPERIMENTAL

Municipalities in the intervention arm will, in Stage 1, be part of developing the intervention to reduce the rate of compulsion. In Stage 2 they will implement the intervention through their services.

Other: Programme to reduce involuntary treatment episodes

Control municipality

NO INTERVENTION

As all outcome measures will be collected from the National Patient Register, there will be treatment as usual.

Interventions

Programme to reduce involuntary treatment episodesOTHER

See description of trial arms

Also known as: Treatment as usual
Intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Municipalities neighbouring another eligible municipality will not be included to prevent contamination should one of them be randomised to the intervention group. The municipality with the lowest rate of involuntary treatment episodes will be removed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Related Publications (1)

  • Rugkasa J, Nyttingnes O, Saltyte Benth J, Husum TL, Kjus SHH, Wormdahl I, Hofstad T, Hatling T. Can primary mental health services impact levels of involuntary admissions? A cluster-RCT of the ReCoN intervention. Soc Psychiatry Psychiatr Epidemiol. 2025 Sep;60(9):2077-2087. doi: 10.1007/s00127-025-02914-3. Epub 2025 Apr 30.

    PMID: 40307589DERIVED

MeSH Terms

Conditions

Compulsive Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Impulsive BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The control group will be masked, but it is not possible to mask the intervention group.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomised controlled trial. 5 clusters per study arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 18, 2019

Study Start

June 25, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

NO(1)