NCT04655287

A Register Study of Effects Following Local Variation in Rates of Involuntary Care

Completed Last updated 29 January 2025

What this trial tests

trial in Schizophrenia and Related Disorders in 21,759 participants. Completed in 31 December 2018.

Timeline

1 January 2015

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	University Hospital, Akershus
Status	Completed
Study type	OBSERVATIONAL
Enrollment	21,759
Start date	1 January 2015
Primary completion	31 December 2018
Estimated completion	31 December 2018

Conditions studied

• Schizophrenia and Related Disorders — all drugs for Schizophrenia and Related Disorders →
• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

University Hospital, Akershus

Who can join

Adults 18 to 65, any sex, with Schizophrenia and Related Disorders or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Involuntary mental health care is permitted because it is believed to make people with severe mental disorders (SMD) better and prevent them from getting worse or even dying In this study we will investigate whether low levels of coercion in an area is connected with poorer outcomes in Norway. It can be assumed that too little involuntary care might lead to the opposite outcomes to those intended by the Norwegian Mental Health Act.

The same law applies all over Norway, but the rate of involuntary care varies: there is up to five-fold difference between the catchment areas of the 69 Community Mental Health Centers. The investigators will estimate rates of involuntary care and adjust for age, sex, urbanity and area deprivation. The data source is the Norwegian Patients Registry, and all patients in treatment for a severe mental disorder in 2015 and their use of mental health care until 2018 will be followed.

Model 1 follows all patients who were treated for a severe mental disorder in 2015. The model will test whether the rates of involuntary care in the area they live can predict the length of time to death.

Model 2 follows patients with treatment for severe mental disorders that had no episode of involuntary care in 2015. The model will test whether the rate of involuntary care in their area predicts their use of mental health inpatient care in 2016 and 2017.

Model 3 tests how long time patients with severe mental disorders that received only voluntary care in 2015 remain without a period of involuntary care in 2016-17, as a function of the rate of involuntary care in their area in 2015.

Model 4 estimates changes in the total number of patients with severe mental disorders in the catchment area in 2016-17 as a function of time and the rate of involuntary in 2015.

Model 5 tests whether suicide rates for a catchment area varies as a function of its rate of involuntary care. Because suicides are rare, we will observe the variables over longer time periods, using involuntary care rates from 2015 to 2018 and suicide rates for 2015-2019.

The study was evaluated by the Research Ethics Committee (ref 2018/795), who approved use of registry data, and by the Privacy Ombudsman at Akershus University Hospital (ref 2018-090).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The relationship between area levels of involuntary psychiatric care and patient outcomes: a longitudinal national register study from Norway.
   Nyttingnes O, Benth JŠ, Hofstad T, Rugkåsa J. · · 2023 · cited 5× · PMID 36803444 · DOI 10.1186/s12888-023-04584-4