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

Suicide Clinical Trial

— N'VIU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284085
• Other study ID #: AC277
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: February 17, 2020

Study information

• Verified date: February 2020
• Source: Consorci Hospitalari de Vic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 17, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide

Intervention

Other:
• Psychoeducational intervention
Psycho-educational groups of 10 to 12 people, led by two professionals, one of them will always be a psychologist and an educator. In some sessions, other collaborators will be invited to participate, such as psychiatrists, educators, social workers, etc. who may act as external observers or implement the session. The number of sessions will be 13, one or two sessions a week and duration of 90 minutes.

Locations

Country	Name	City	State
Spain	Vic University Hospital	Vic	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Hospitalari de Vic	Government of Catalonia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of suicidal behaviours	Total number of suicidal behaviors recorded during 12 months after the start of the study in both groups.	12 months
Secondary	Severity of suicidal ideation	Severity of suicidal ideation (Columbia-Suicide Severity Rating Scale, C-SSRS). Intensity of Ideation subscale, the total score ranges from 2 to 25,with a higher number indicating more intense ideation and greater risk.	6 months
Secondary	Levels of Anxiety	Hamilton Anxiety Rating Scale (HARS): Total score range of 0-56, where <17 indi-cates mild severity, 18-24 mild to moderate severity and25-30 moderate to severe.	6 months
Secondary	Levels of depression	Hamilton Depression Rating Scale (HDRS). Score: 0-7: No depression; 8-13: Mild depression; 14-18: Moderate depression; 19-22: Severe depression and = 23: Very severe depression.	6 months
Secondary	Level of Quality of life: EuroQoL-5D Health Questionnaire, EQ-5D	Quality of life (EuroQoL-5D Health Questionnaire, EQ-5D). Score: 0 (worst imagined state of health) to 100 (best imagined state of health).	6 months