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Clinical Trials/NCT05195554
NCT05195554
Unknown
N/A

Effectiveness of a Psycho-educational Intervention for People With Suicidal Conduct in the Prison Environment. N'VIU Project: a Randomized Control Trial

Consorci Hospitalari de Vic1 site in 1 country178 target enrollmentJanuary 15, 2022
ConditionsSuicide

Overview

Phase
N/A
Intervention
Not specified
Conditions
Suicide
Sponsor
Consorci Hospitalari de Vic
Enrollment
178
Locations
1
Primary Endpoint
Total number of suicidal behaviours
Last Updated
4 years ago

Overview

Brief Summary

This study has been designed as a multicentric, randomized, two parallel-group, controlled trial. The study population will be male and female inmates of nine prisons of Catalonia (Spain). The primary outcome will be the total number of suicidal behaviours for 12 months of follow-up. This project aims to assess the effectiveness of a psycho-educational intervention on reducing the number of suicidal behaviours in the prison environment. If positive, the prison community will have a new tool to curb suicide in prisons.

Detailed Description

Background: Suicide rates are higher in the prison environment than in the general population. Prevention involves strategies to promote mental health, early diagnosis, treatment and identification of precipitating factors. The aim of this study is to evaluate the effectiveness of a psychoeducational group intervention performed by rehabilitation professionals to decrease the number of suicidal behaviors in the penitentiary environment. Methods: This study has been designed as a multicentric, randomized, two parallel-group, controlled trial. The study population will be male and female inmates of nine prisons of Catalonia (Spain). The primary outcome will be the total number of suicidal behaviours for 12 months of follow-up. Secondary outcomes will be suicide risk evaluated with the International Neuropsychiatric Interview (MINI); the severity of suicidal ideations assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS), the presence of depressive and anxiety symptoms \[Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HARS)\] and health-related quality of life (EQ-5D). Other variables will be clinical and socio-demographic. Intervention will consist of 17 psychoeducation sessions for the intervention group and information on suicide for the control group. Conclusions: This project aims to assess the effectiveness of a psycho-educational intervention on reducing the number of suicidal behaviours in the prison environment. If positive, the prison community will have a new tool to curb suicide in prisons.

Registry
clinicaltrials.gov
Start Date
January 15, 2022
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Pere Roura-Poch

Head of epidemiology

Consorci Hospitalari de Vic

Eligibility Criteria

Inclusion Criteria

  • Participants who have presented some kind of suicidal or high-risk behavior in the criterion of self-directed violence according to the RisCanvi\*.

Exclusion Criteria

  • Decompensation of severe mental disorder
  • Intellectual disability
  • Cognitive impairment.
  • Isolation
  • RisCanvi is an instrument used by penitentiary professionals, based on the individualized and structured assessment of a set of pre-established variables, in order to manage the probabilities of increased and decreased risk of prison inmates for further episodes of violent behavior. The full RisCanvi scale consists of 43 risk factors grouped in the following areas: criminological, personal and biographical, social, family, clinical, and personality. These 43 factors are added to the assessment of the future risk of the emergence of four behaviors: self-directed violence, intra-institutional violence, repeat violence, and prison-breaking).

Outcomes

Primary Outcomes

Total number of suicidal behaviours

Time Frame: 12 months

The primary outcome will be the total number of suicidal behaviours -which includes both suicide attempts and suicides- registered during the first year after being included in the study.

Secondary Outcomes

  • Suicide risk(12 months)
  • Severity of suicidal ideation(12 months)
  • Depression(12 months)
  • Anxiety(12 months)
  • Quality of life (QOL)(12 months)

Study Sites (1)

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