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

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.

Study Overview

• Status: Completed
• Conditions: Suicide
• Intervention / Treatment: Other: Psychoeducational intervention

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Vic, Catalonia, Spain, 08500
      • Vic University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; There will be 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.	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.
No Intervention: Control group; They will receive a fact sheet on suicide and also tips on how to increase suicidal ideation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Consorci Hospitalari de Vic
• Collaborators: Government of Catalonia

Publications and helpful links

General Publications

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: AC277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No