NCT04284085: N'VIU

Evaluation of a Psychoeducational Intervention for People With Suicidal Behaviour in the Penitentiary Environment. N'VIU Project

Completed NA Last updated 25 February 2020

What this trial tests

NA trial testing Psychoeducational intervention in Suicide in 96 participants. Completed in 17 February 2020.

Timeline

15 October 2019

Primary endpoint
20 January 2020

17 February 2020

Quick facts

Lead sponsor	Consorci Hospitalari de Vic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	96
Start date	15 October 2019
Primary completion	20 January 2020
Estimated completion	17 February 2020
Sites	1 location across Spain

Drugs / interventions tested

• Psychoeducational intervention

Conditions studied

• Suicide — all drugs for Suicide →

Sponsor

Consorci Hospitalari de Vic

Who can join

18 and older, any sex, with Suicide. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective. The main objective is to determine the effectiveness of a psychoeducational program conducted by rehabilitation professionals to reduce the number of suicidal behaviors in prisons.

Methodology. The design of the study will be a multicenter, randomized, two-group clinical trial with blind evaluation of response variables, one year follow-up. The study population will be a male and female prison population of a total of two Catalan prisons. As a dependent or outcome variable, the total number of suicidal behaviors recorded for 12 months after the intervention will be determined. As independent variables, socio-demographic, clinical and prison situation variables will be collected. The suicidal ideation will be measured with the Columbia-Suicide Severity Rating Scale (C-SSRS). The anxiety and depression with Hamilton scale for assessing anxiety (HDRS) and the Hamilton scale for assessing severity of depressive symptoms (HAM-D). The EuroQoL-5D Health Questionnaire (EQ-5D) to measure quality of life. And a satisfaction survey of psychoeducational group intervention. Participants who meet the inclusion criteria will be divided into two groups, an intervention group that will conduct group sessions with a frequency of two per week and duration of 90 minutes for a total of 13 sessions, and a control group that will receive information on suicide counseling.

Discussion. Mortality from suicide is higher in the prison population than in the general population. This project aims to evaluate the effect of a psychoeducational intervention on reducing the number of suicidal behaviors in prison, in order to evaluate their implementation at the level of the entire prison network.

Publications & conference data

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

1. Psychosocial interventions for self-harm in adults.
   Witt KG, Hetrick SE, Rajaram G, Hazell P, et al · · 2021 · cited 79× · PMID 33884617 · DOI 10.1002/14651858.cd013668.pub2