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Clinical Trials/NCT04284085
NCT04284085
Completed
N/A

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

Consorci Hospitalari de Vic1 site in 1 country96 target enrollmentOctober 15, 2019
ConditionsSuicide

Overview

Phase
N/A
Intervention
Not specified
Conditions
Suicide
Sponsor
Consorci Hospitalari de Vic
Enrollment
96
Locations
1
Primary Endpoint
Number of suicidal behaviours
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
February 17, 2020
Last Updated
6 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

  • People who have attempted suicide or a risk of suicide moderate to high.

Exclusion Criteria

  • People with a mental disorder in a state of acute exacerbation
  • Intellectual disability
  • Cognitive impairment

Outcomes

Primary Outcomes

Number of suicidal behaviours

Time Frame: 12 months

Total number of suicidal behaviors recorded during 12 months after the start of the study in both groups.

Secondary Outcomes

  • Levels of depression(6 months)
  • Severity of suicidal ideation(6 months)
  • Levels of Anxiety(6 months)
  • Level of Quality of life: EuroQoL-5D Health Questionnaire, EQ-5D(6 months)

Study Sites (1)

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